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M.pharm chemistry.doc

STUDY AND EVALUATION SCHEME

Course: M. Pharm. (Pharmaceutical Chemistry) Effective From Session 2009- – 10
SEMESTER - I

(hours/week)
Course Code
MPHR- 111
Pharmaceutical Statistics & Computer MPHR- 112
Drug Regulatory Affairs & Intellectual Property MPHR- 113
MPHR- 114
PRACTICAL
Day to Day Evaluation
MPHR- 111 P
MPHR- 114 P
T- Theory, P- Practical, IA- Internal Assessment, ESE- End Semester Examination
Note: Duration of ESE – Theory exam will be of 3 hours and Practical exam of 8 hours
STUDY AND EVALUATION SCHEME

Course: M. Pharm. (Pharmaceutical Chemistry)
SEMESTER - II

(hours/week)
Course Code
MPHR- 121
MPHR- 122
MPHR- 123
MPHR- 120
PRACTICAL
Day to Day Evaluation
MPHR- 122 P
MPHR- 123 P
T- Theory, P- Practical, IA- Internal Assessment, ESE- End Semester Examination
Note: Duration of ESE – Theory exam will be of 3 hours and Practical exam of 8 hours
STUDY AND EVALUATION SCHEME
Course: M.Pharm (Pharmaceutical Chemistry)
Semester-III
Course Code
MPHR- 231
Evaluation of Project Work after Six Months STUDY AND EVALUATION SCHEME
Course: M.Pharm (Pharmaceutical Chemistry)
Semester-IV
Course Code
MPHR- 241
MPHR- 242
SEMESTER -I
MPHR 111

ADVANCED ANALYTICAL TECHNIQUES
Unit –I:
UV-Visible spectroscopy
- Introduction, factors governing absorption of radiation in the UV/visible
region, Beer-Lambert Law and its deviation, chromophore concept, Woodward-Fieser rule,
Instrumentation and instrument calibration, Diode array instruments. Study of UV spectra of some
representative drug molecules. Application in determination of pKa values, pharmaceutical quantitative
analysis, preformulation and formulation. Difference spectrophotometry, derivative spectra.
Solid State Analysis: X-ray diffraction and crystallography, thermal analysis and calorimetry,
micromeritic measurements.
Unit –II:
Infrared spectroscopy
- Introduction, Molecular vibrations, factors influencing vibrational frequencies,
Instrumentation and instrument calibration, sample preparation techniques. Application in structure
elucidation and in identifying polymorphs. I R as a fingerprint technique. Near IR analysis and its
applications, FTIR.
Unit –III:
a) Atomic spectrophotometry:
Atomic emission spectrophotometry: principle, instrumentation, interferences and
applications.
Atomic absorption spectrophotometry: principle, instrumentation and applications.
b) Molecular emission spectroscopy :
Fluorescence spectroscopy: Principles, molecules exhibiting fluorescence, factors interfering with
fluorescence intensity, application.
Raman spectroscopy: Principle, instrumentation and applications.
Unit –IV:
a) Nuclear Magnetic Resonance Spectroscopy :
Introduction, instrumentation, chemical shifts, shielding and deshielding effects, spin-spin coupling,
reference standard and solvents, proton NMR, carbon-13 NMR and 2D NMR spectra. Application to
structure confirmation and quantitative analysis.
b) Mass Spectrometry:
Principle, instrumentation, mass spectra obtained under electron impact (EI) ionization conditions,
molecular fragmentation patterns, molecular ion, metastable ion, McLafferty rearrangement, EI mass
spectra of some drug molecules.
GC-MS and LC-MS: principle and applications.
Unit –V:
Chromatographic techniques:
Chromatographic Theory: void volume, capacity factor, band broadening, calculation of column
efficiency, parameters used in evaluating column performance (resolution and peak asymmetry).
HPLC: instrumentation, stationary phases, mobile phases and its selection, columns and detectors,
applications in quantitative analysis of drugs in formulations, specialized HPLC techniques.
HPTLC, GC, High-performance capillary electrophoresis: principle, instrumentation and application.

MPHR – 111P
Practicals
1. Combination Drug Analysis (Any Five)
a. Vitamins
b. Oral antidiabetics
c. NSAIDs
d. Antimicrobials
e. Antihistamines
f. Antihypertensive
2. Illustrations of theoretical principles using assay of drugs official in various pharmacopoeias (Any
10). This should cover titrimetric, spectro-photometric (including flamephotometric) methods, HPLC etc. The titrimetric methods should include argentometric, conductometric, and potent iometric end-point determination. The students should be exposed to handling of as many instruments as possible by themselves or 3. Interpretation of UV and IR spectra of some unknown intermediates and drugs. (Any two) Books Recommended: (Latest Edition)
1- Watson, D.G., Pharmaceutical Analysis, A Textbook for Pharmacy Students and Pharmaceutical Chemists, Elsevier Churchill Livingstone. 2- Lee, D.C., Webb, M., Pharmaceutical Analysis, Blackwell Publishing, CRC Press, Wiley India 3- Willard, H. H., Merrit, L.L., Dean, J. A., Settle P. A., Instrumental Methods of Analysis, Von 4- Skoog, D.A., Holler, F.J., Nieman, T.A., Principles of Instrumental Analysis, Thomson 5- Christian, G, D., Analytical Chemistry, John Wiley and Sons. 6- Ahuja,S., Rasmussen,H., HPLC method development for Pharmaceuticals, Elesevier Academic 7- Silverstein, Spectrometric identification of Organic Compounds, Willy. 8- Kemp William, Organic Spectroscopy, Pal grave, New York. 9- Beckett and Stenlake, Practical Pharmaceutical Chemistry, CBS Publishers, New Delhi. 10- Sethi, P.D., Quantitative Analysis of Drugs in Pharmaceutical Formulations, CBS Publishers, MPHR- 112 Pharmaceutical Statistics and Computer Applications

Unit- I.

Basic Definitions and Concepts: Variables and Variation, Frequency Distributions and Cumulative Frequency
Distributions, Sample and Population, Measures Describing the center of Date Distributions, Measurement of the
Spread of Date, Coding, Precision, Accuracy and Bias, The Question of Significant Figures.
Data Graphics: Introduction, the Histogram, Construction and Labeling of Graphs, Scatter Plots (Correlation
Diagrams), Semilogarithmic Plots, Other Descriptive Figures.
Introduction to Probability The Binomial and Normal Probability Distributions : Introduction, Some Basic
Probability, Probability Distributions, the Binomial Distribution, Continuous Data Distributions, Other Common
Probability Distributions.
Unit- II
Choosing Samples:
Introduction, Random Sampling, Other Sampling Procedures: Stratified, Systematic, Cluster
Sampling, Sampling in Quality Control.
Statistical Inference: Estimation and Hypothesis Testing: Statistical Estimation (Confidence Intervals), Statistical
Hypothesis Testing, Comparison of Variances in Independent Samples, Test of Equality of More than Two Variances
confidence limits for variance Tolerance Intervals.
Sample Size and Power: Introduction, Determination of Sample Size for Simple Comparative Experiments for
Normally Distributed Variables, Determination of Sample Size for Binomial Tests, Determination of Sample Size to
Obtain a Confidence Interval of Specified Width, Power, Sample Size and Power for More than Two Treatments,
Sample Size for Bioequivalence Studies.
Unit- III
Linear Regression and Correlation:
Introduction, Analysis of Standard Curves in Drug Analysis: Application of
Linear Regression, Assumptions in Tests of Hypotheses in Linear Regression, Estimate of the Variance: Variance of
Sample Estimates of the Parameters, A Drug Stability Study: A Second Example of the Application of Linear
Regression, Confidence Intervals in Regression Analysis, Weighted Regression, Analysis of Residuals, Nonlinear
Regression Correlation, Comparison of Varia nces in Related Samples.
Analysis of Variance: One- Way Analysis of Variance Planned Versus a Posteriori (Unplanned) Comparisons in
ANOVA, Another Example of One- Way Analysis of Variance: Unequal Sample Sixes and the Fixed and Random
Models, Two-Way Analysis of Variance (Randomized Blocks), Statistical Models, Analysis of Covariance, ANOVA
for pooling regression lines as related to stability data.
Factorial Designs : Definitions Two Simple Hypothetical Experiments to Illustrate the Advantages of Factorial
Designs, Performing Factorial Experiments: Recommendations and Notation, A Worked Example of a Factorial
Experiment, Fractional Factorial Designs.



Unit- IV
Transformations and Outliers:
Transformations, Outliers
Experimental Design in Clinical Trials: Introduction, Some Principles of Experimental Design and Analysis, Parallel
Deign, Crossover Designs and Bioavailability / Bioequivalence Studies, Repeated Measures (Split- Plot) Designs,
Multiclinic Studies, Interim Analyses.
Quality Control: Introduction, Control Charts, Acceptance Sampling and Operating Characteristic Curves, Statistical
Procedures in Assay Development, Establishing In- House Limits, Some Statistical Aspects of Quality and the “Barr
Decision”, Important QC Tests for Finished solid Dosage Forms (Tablets and Capsules), Out of Specification (OOS)
Results.
Validation: Process Validation, Assay Validation.

Unit- V
Nonparametric Methods:
Data Characteristics and an Introduction to Nonparametric Procedures, Sign Test, Wilcoson
Signed Rank Test, Wilcoxon Rank Sum Test (Test for Differences Between Two Independent Groups), Kruskal
Wallis Test (One- Way ANOVA), Friedman Test (Two- WAY Analysis of Variance), Nonparametric Analysis of
Covariance, Runs Test for Randomness, Contingency Tables, Non Parametric Tolerance Interval.

Optimization Techniques and Screening Designs:
Introduction, Optimization Using Factorial Designs, Composite
Designs to Estimate Curvature, The Simplex Lattice, Sequential Optimization.

Applications of Computers in Pharmaceutical Sciences
Computer Intensive Methods:
Monte Carlo Simulation, Bootstrapping
Book Recommended:

1. Bolton, S and Bon, C, Pharmaceuticals Statistics- Practical & Clinical Applications, Marcel &
2. Fisher, R.A., Statistical Methods for Research Works, Oliver & Boyd, Edinburgh.
3. Chow, Statistical Design and Analysis of Stability Studies, Marcel Dekker, New York.
4. Buncher, Statistics in the Pharmaceutical Industry, Marcel Dekker, New York.
5. William E. Fassett, Computer Application in Pharmacy.
6. Ekins, S., Computer Application in Pharmaceutical Research & Development, Wiley.
MPHR- 113 DRUG REGULATORY AFFAIRS & INTELLECTUAL PROPERTY RIGHTS
A. Drug Information
Introduction
Primary, Secondary & Tertiary Literature
Spectrum of information, finding and managing Drug Information.
B. Drugs and Cosmetics Act and rules with special reference to schedule M and Y.
Unit- II
International Drug Regulatory affairs- registration procedure (Pharmaceutical products) for International Marketing,
Including preparation of dossiers SMF, Validation, Calibration and other documents like product development, stability
data for different countries.

Unit- III
Facilities for manufacturing pharmaceutical products qualifying.
CGMP requirements - 21 CFR parts 210 and 211, Orange Guide, TRS, ICH, etc.
Unit- IV
Facilities for quality control lab qualifying GLP requirements, facilities for warehouse qualifying GWP requirements.
Unit- V
Intellectual property rights, patents Act, Trademark and Copyright Act
Books Recommended:
1. Gennaro A.R., Remington- The science and practice of pharmacy, Lippircott, Williams & Wilkins.
2. Banker G.S., Rhodes C.T., Modern Pharmaceutics, Marcel Dekker.
3. Malik Vijay, Drug & Cosmetics Act, 1940, Eastern Book Company, Lucknow.
4. Guarino R.A., New Drug Approval Process, Marcel Dekker.
5. Sharma P.P., How to practice GMP, Vandana Prakashan, New Delhi.
6. Sharma P.P., how to practice GLP, Vandana Prakashan, New Delhi,
7. World Health Organization, quality assurance of Pharmaceuticals I & I, Pharma Book Syndicate, Hyderabad.
8. Weinlerg S., Good Laboratory Poactices, Marcel Dekker.
9. The Patent Act, 1970
10. The Trade Marks Act, 1999.
11. The Copyright Act, 1958.
12. Potdar M.A., Current Good Manufacturing Practices for Pharmaceuticals, Pharma Med Press, Hyderabad.
13. Rick N.G., Drug from Discovery to Approval, Wiley Black Well.
14. Swarlerick J., Boylan J., Encyclopedia / Pharmaceutical Technology Relevant Welesites of Regulatory
ADVANCED ORGANIC CHEMISTRY
Unit-I
Organic Reactions:
Mechanism, reactivity and reactions of-
a) Aliphatic and Aromatic electrophilic substitution.
b) Aliphatic and Aromatic nucleophilic substitution.
c) Free radical reactions.
d) Elimination reactions.

Unit-II
Name reactions
: Mechanism and applications in drug synthesis of following name reactions-
a) Beckmann Rearrangement b) Birch reduction c) Claisen Schimidt d) Diel’s Alder reaction e)
Grignard f) Hoffmann rearrangement g) Mannich h) Meerwein Ponndorf- Verley reduction i)
Oppenauer oxidation j) Perkin k) Reformatsky l) Wolf Kishner reduction.

Unit-III
Organic synthetic techniques involved in drug research, Protection and deprotection of functional
groups, Introduction to asymmetric synthesis, Microwave reactions.

Unit-IV
Stereochemistry and Chiral Techniques:
Principles of stereochemistry, optical rotation and optical rotatory dispersion.
Stereochemistry of five and six membered rings, fused and bridged rings.
Concept of chirality, chiral drugs, resolution procedures of racemic mixtures, asymmetric
synthesis of propranol, omeprazole,nifedipine and ethambutol.

Unit-V
Photochemical reaction
: light absorption, electronic transition, photosensitization, photochemistry of
conjugated dienes, enones.
Synthone Approach: Definition, terms, rules and guidelines used in synthesis of following drugs-
trimethoprim, ibuprofen, ciprofloxacin and diclofenac.



MPHR- 114P
Practicals:

1. Experimental techniques – Fractional distillation, Vacuum distillation, Preparative chromatography-
Column and TLC.
2. Synthesis of any five different heterocyclic compounds using reactions discussed under unit II of
theory syllabus.
3. Practical illustrations of any five reactions described in the unit II of theory syllabus.
4. Principles, mechanism and techniques of stereo controlled synthesis of Nifedipine, Chloroxazone and
Paracetamol.

Books Recommended: (Latest Edition)

1. J. March, Advanced Organic Chemistry, Reactions, Mechanism and Structures, JohnWiley & 2. M. E. Wolff, Burger’s Medicinal Chemistry and Drug discovery, Principle and Practice, John 3. Nogrady, Medicinal Chemistry, A Bio Chemical Approach, Oxford University Press, Oxford. 4. Laszlo Kurti, Barbara Czako, Strategic Applications of name reactions in Organic synthesis, 5. Eliel and H. Samuel, Stereochemistry of Organic compounds, John Wiley & Sons, New York. 6. Practical Organic Synthesis: A Student's Guide - Reinhart Keese, Martin Brändle, Trevor Toube 7. Norman, Principles of Organic Synthesis, Nelson Thornes, U.K. 8. Solomens and Fryhle, Organic Chemistry, John Wiley & Sons, Singapore. 9. Wade, Singh, Organic Chemistry, Dorly Kindersley, India. 10. Eliel, Willen, Mander, Stereochemistry of organic compounds, John Wiley & Sons, U.K. SEMESTER - II
MPHR-121 DRUG DESIGN

Unit-I

Introduction to Drug Design Concept, Lead Discovery, drug-receptor interactions Physicochemical
Properties in Relation to Biological Action, Stereoche mical Aspects in Drug Design.
Unit-II

Drug metabolism- Phase-I & Phase-II Metabolic Reactions, Introduction to Drug Designing on the Basis of
Metabolic Pathways, Analytical methods in drug metabolism. Prodrugs - Bioprecursor & Carrier Linked Prodrugs, Hard and Soft Drugs.
Unit-III

Analog Based Drug Design-Introduction, Designing of Analogs.
Structure Based Drug Design- Introduction, Drug Design on Structure Based.
Unit-IV

Combinatorial Chemistry- Introduction , Solid Phase Synthesis, Liquid Phase Synthesis, Methods of
Parallel and Mixed Combinatorial Synthesis, Deconvolution and High Throughput 0creening .
Unit-V

Molecular Modeling- Introduction to Molecular Mechanics, Quantum Mechanics, Molecular Dynamics,
Molecular Graphics and Molecular Docking. QSAR- Introduction, steric effects, methods used to correlate physicochemical Parameters with biological
activity, Quantitative Models, Introduction to 2D and 3D QSAR.
Books Recommended

1. Smith HJ, Williams H, eds, “ Introduction to the principles of Drug Design” Wright Boston.
2. Silverman R.B. “ The organic Chemistry of Drug Design and Drug Action” Academic Press New York. 3. Robert GCK,ed., “ Drug Action at the Molecular Level” University Prak Press Baltimore. 4. Martin YC. “ Quantitative Drug Design” Dekker, New York. 5. Lien EJ. SAR “ Side effects and Drug Design” Dekker, New York. 6. William H, Malick JB “ Drug Discovery and Dovelopment” Humana Press Clifton. 7. Delgado JN, Remers WA eds “ Wilson & Gisvolds’s Text Book of Organic Medicinal & Pharmaceutical 8. Foye WO “ Principles of Medicinal chemistry ‘ Lea & Febiger. 9. Koro lkovas A, Burckhalter JH. “Essentials of Medicinal Chemistry” Wiley Interscience. 10. Wolf ME, ed “The Basis of Medic inal Chemistry, Burger’s Medicinal Chemistry” John Wiley & Sons, 11. Ariens EJ “ Drug Design” Academic Press New York. 12. Olson EC “Computer Assisted Drug Design” American Chemical Society ACS Symposium Series 112. 13. Roberts SM, Price B.J.Eds. “ Medicinal Chemistry. The Role of Organic Chemistry in Drug Research “ 14. Pope & Perruuns “ Computer Aided Drug Design “ Academic Press New York. 15. Thomas , G.Medicinal Chemistry-An Introduction John Wiley and sons Ltd. 16. Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University Press. 17. Fischer Janos, Ganellin C. Robin “Analogue-based drug Discovery, Wiley-VCH Verlag Gmb H & Co. 18. Pandi, Veerapandian “Structure based drug design New York Marcel Dekker, inc., 1997. 19. Wermuth GC, “The Practice of Medicinal Chemistry” Second edition, Academic Press, Elsevier MPHR- 122 ADVANCED MEDICINAL CHEMISTRY
Psychopharmacological agents: a) Biochemical basis of mental disorders:- Abnormal protein factors,
endogenous amines and related substances, faulty energy metabolism, geneticfactors and nutritional
disorders; Phenothiazines: chemistry, synthesis and evaluation methods. The important pharmacological
activities of phenothiazines; SAR of phenothiazines, toxicity and clinical significance of phenothiazines.
b) Antidepressants: MAO inhibitors, tricyclic antidepressants and miscellaneous compounds.
Mechanism of action, clinical and biological uses side effects and their SAR studies. Synthesis of
clinically useful drugs of each of the above classes.

Unit- II
Chemotherapy of Cancer:
A detailed classification of antineoplatic agents, mechanisms of action of
different classes; Alkylating agents and radiomimetic agents, antimetabolites, their SAR studies, sex
hormones & analogs, and antibiotics. A mention of natural products used in cancer treatment; Vinca
alkaloids (Vincristine and Vinblastine) podophyllum and paclitaxel.
Unit- III
Advances in therapeutic agents for cardiovascular disorders:
Antihypertensive, Antiarrhythmics, Antihyperlipidemics.
Unit- IV
Miscellaneous Classes of Drugs:
Recent advances in the following classes of drugs:
Proton-pump inhibitors as antiulcer agents.
Immunosuppressive and immunostimulant agents.
Antiviral agents.
ß – Adrenergic blockers.
Unit- V
Steroids:

Steroid nomenclature, stereochemistry and numbering; New insights on steroid receptors; chemical and
physical properties of steroids; changes to modify pharmacokinetic properties of steroids. Sources and
structure elucidation of cholesterol; sources and structures of related steroids – Ergosterol. Stigmasterol,
ß- sitosterol and Diosgenin.
Steroidal Anti- inflammatory Agents; structures; structure-activity relationships; therapeutic uses. Steroidal Anti- fertility agents: Structures; mechanism of action; regimen. MPHR- 122P
PRACTICALS
1. Synthesis of compounds using 3-4 steps, structure confirmation by spectroscopic methods.
2. Resolution of racemic mixture.
3. Determination of partition coefficient, pka.

Books Recommended

1. Foye: Principles of Medicinal Chemistry, 6 ed. (Lippincott).
2. Ariens: Medicinal Chemistry Series.
3. Ellis and West: Progress in Medicinal Chemistry Series.
4. Butterworthser: Progress in Medicinal Chemistry Series.
5. Burgers Medicinal chemistry-The Basis of Medicinal chemistry by Manfred E. Wolff part-I (John
6. Medicinal chemistry – The Role of organic chemistry in drug research by S.M.Roberts and
7. Vogel’s Textbook of practical organic chemistry by Arthur I Vogel (ELBS and Lognman)
8. The Organic Chemistry of Drug Synthesis (3 volumes) by Daniel Lednicer & Laster A. Mitscher
9. An Introduction to Organic Laboratory Manual by Pavia, Lampman and Chris.
10. Principles of Organic and Medicinal Chemistry – Munson.
11. Comprehensive Medicinal Chemistry – Hansch and Leo.
ADVANCED CHEMISTRY OF NATURAL PRODUCTS

Unit-I
Natural sources of drugs (Plant, animal, microbial, and marine), Role of natural products in development
of medicinal chemistry, providing “leads”.
WHO Guidelines for assessment of crude drugs: Evaluation of identity, purity, and quality of crude
drugs, Determination of pesticide residue, Determination of Micro-organisms.
Unit-II
Study of Herbal Extracts: Processing, equipment and analytical profiles. Sterility, stability and
preservation of extracts.
Phytochemical screening of crude drugs: Extraction, isolation, purification,
characterization of following phytoconstituents.
Alkaloids: Caffeine, Morphine
Glycosides: Digoxin, Sennosides
Flavonoids: Rutin, Quercetin
Saponins: Glycyrrhizinic acid, Diosgenin
Unit-III
Brief introduction to Pharmacological Screening Methods with example of
Following category of medicinal herbs:
a) Hepatoprotecives
b) Antidaibetics
c) Hypolipidaemics
d) Antioxidants
e) Anti- inflammatory, analgesics.
f) Wound Healing
Unit-IV
Study of the following classes of alkaloids :

Alkaloids of Opium: Structure elucidation of Morphine, structure activity relationships in morphine
molecule.
Alkaloids of Atropa belladonna: Atropine, Hyoscyamine and Hyoscine, Structure elucidation of
Atropine, Therapeutic uses.
Alkaloids of Vinca rosea: Vincristine and vinblastine, structure elucidations, Structural modifications
and semisynthetic derivatives.
Alkaloids of Ergot: Classification, Structures, Structure elucidation of Ergometrine, therapeutic uses of
ergot alkaloids and derivatives (vinyl and methylsergide).
Unit-V
A Brief Account of the Following:
a) Anticancer Agents of Plant Origin: Sources and structures of podophyllotoxin, Taxol and
camptothecin; their semi synthetic derivatives, uses and mechanism of action.
b) Ginseng: Historical background, structures and uses of Ginsenosides, protopanaxadiols and triols.
c) Phototherapy: sources and structures of psoralens, Photodegradation of 8-methoxy psoralen, PUVA
therapy in psoriasis and ritiligo.



MPHR 123P
Practicals

1. Extraction, isolation, purification and characterization of important phytoconstituents
belonging to different classes.
a. Eugenol from Clove b. Sennosides from Senna c. Curcumin from Turmeric d. Glycerrhizin from Liquorice e. Hesperidine from Orange Peels f. Caffeine from Tea g. Strychnine and Brucine from Nux Vomica h. Cineole from Eucalyptus 2. Study of UV, Visible, and IR Spectral data of some phytoconstituents.
3. Study of HPLC and HPLTC (if possible) Techniques for some important
phytoconstituents.
4. Antimicrobial screening of plant extracts.
5. Screening of drugs for microbial count.
6. Experiments based on WHO guidelines of quality control of medicinal plant materials.

Books recommended: (Latest Edition)

1. Trease and Evans, Pharmacognosy, Saunders Company, London. 2. Tyler, Brady, and Robbers, Pharmacognosy, Lea Febiger, USA. 3. Kokate, Purohit, Gokhale, Pharmacognosy, Nirali Prakashan, Pune. 4. Agrawal O.P., Chemistry of Organic Natural Product, Vol. 1 and 2 Goel Publication House, UP. 5. Nadkarni, A.K., Indian Materia Medica. 2 volumes, Popular Prakashan Pvt. Ltd. 6. WHO, Quality Control methods for medicinal plant material. 7. Mukherjee Pulok, Quality Control of Herbal Drugs, Business Horizons. 8. Wagner, H., Bladt, S., Zgaimski, E.M. Plant Drug Analysis., Springer- Verlog, New York 9. Screening Methods of Pharmacology, by Robert Turner. 10. Biological Standardisation by, J. N. Barn, D. J. Finley and L. G. Goodwin 11. Matrindale, The extra Pharmacopoeia, Pharmaceutical press, London. 12. K.B.G. Torsell, Natural products chemistry, John Wiley & Sons, New York. 13. J. B. Harborne, Phytochemical methods, Chapman and Hall, London. 14. Monographs and relevant review articles appearing in various Periodicals and Journals. 15. Standardisation of Botanicals by V.Rajpal, Vol.1, Eastern Publishers, New Delhi. 16. Quality Standards of Indian Medicinal Plants, Vol 1, ICMR, New Delhi.
MPHR 120 SYNOPSIS OF THE PROPOSED PROJECT

SEMESTER - III
MPHR 231 EVALUATION OF PROJECT WORK AFTER SIX MONTHS
SEMESTER- IV
MPHR 241 THESIS
MPHR 242 PRESENTATION & VIVA- VOCE
STUDY AND EVALUATION SCHEME

Course: M. Pharm. (Pharmaceutics) Effective From Session 2009- – 10
SEMESTER - I

(hours/week)
Course Code
MPHR- 111
Pharmaceutical Statistics & Computer MPHR- 112
Drug Regulatory Affairs & Intellectual Property MPHR- 113
MPHR- 115
PRACTICAL
Day to Day Evaluation
MPHR- 111 P
MPHR- 115 P
T- Theory, P- Practical, IA- Internal Assessment, ESE- End Semester Examination
Note: Duration of ESE – Theory exam will be of 3 hours and Practical exam of 8 hours
STUDY AND EVALUATION SCHEME

Course: M. Pharm. (Pharmaceutics)
SEMESTER - II

(hours/week)
Course Code
MPHR- 124
MPHR- 125
MPHR- 126
MPHR- 120
PRACTICAL
Day to Day Evaluation
MPHR- 125 P
MPHR- 126 P
T- Theory, P- Practical, IA- Internal Assessment, ESE- End Semester Examination
Note: Duration of ESE – Theory exam will be of 3 hours and Practical exam of 8 hours
STUDY AND EVALUATION SCHEME
Course: M.Pharm (Pharmaceutics)
Semester-III
Course Code
MPHR- 231
Evaluation of Project Work after Six Months STUDY AND EVALUATION SCHEME
Course: M.Pharm (Pharmaceutics)
Semester-IV
Course Code
MPHR- 241
MPHR- 242
SEMESTER - I
ADVANCED ANALYTICAL TECHNIQUES

Unit –I:
UV-Visible spectroscopy
- Introduction, factors governing absorption of radiation in the UV/visible
region, Beer-Lambert Law and its deviation, chromophore concept, Woodward-Fieser rule,
Instrumentation and instrument calibration, Diode array instruments. Study of UV spectra of some
representative drug molecules. Application in determination of pKa values, pharmaceutical quantitative
analysis, preformulation and formulation. Difference spectrophotometry, derivative spectra.
Solid State Analysis: X-ray diffraction and crystallography, thermal analysis and calorimetry,
micromeritic measurements.

Unit –II:
Infrared spectroscopy
- Introduction, Molecular vibrations, factors influencing vibrational frequencies,
Instrumentation and instrument calibration, sample preparation techniques. Application in structure
elucidation and in identifying polymorphs. I R as a fingerprint technique. Near IR analysis and its
applications, FTIR.

Unit –III:

a) Atomic spectrophotometry:
Atomic emission spectrophotometry: principle, instrumentation, interferences and applications.
Atomic absorption spectrophotometry: principle, instrumentation and applications.

b) Molecular emission spectroscopy :
Fluorescence spectroscopy: Principles, molecules exhibiting fluorescence, factors interfering with
fluorescence intensity, application.
Raman spectroscopy: Principle, instrumentation and applications.

Unit –IV:

a) Nuclear Magnetic Resonance Spectroscopy :
Introduction, instrumentation, chemical shifts, shielding and deshielding effects, spin-spin coupling,
reference standard and solvents, proton NMR, carbon-13 NMR and 2D NMR spectra. Application to
structure confirmation and quantitative analysis.

b) Mass Spectrometry:
Principle, instrumentation, mass spectra obtained under electron impact (EI) ionization conditions,
molecular fragmentation patterns, molecular ion, metastable ion, McLafferty rearrange ment, EI mass
spectra of some drug molecules.
GC-MS and LC-MS: principle and applications.

Unit –V:

Chromatographic techniques:
Chromatographic Theory: void volume, capacity factor, band broadening, calculation of column
efficiency, parameters used in eva luating column performance (resolution and peak asymmetry). HPLC:
instrumentation, stationary phases, mobile phases and its selection, columns and detectors, applications
in quantitative analysis of drugs in formulations, specialized HPLC techniques. HPTLC, GC, High-
performance capillary electrophoresis: principle, instrumentation and application.


MPHR – 111P
Practicals
1.
Combination Drug Analysis (Any Five)
a. Vitamins b. Oral antidiabetics c. NSAIDs d. Antimicrobials e. Antihistamines f. Antihypertensive 2. Illustrations of theoretical principles using assay of drugs official in various pharmacopoeias (Any
10). This should cover titrimetric, spectro-photometric (including flamephotometric) methods, HPLC
etc. The titrimetric methods should include argentometric, conductometric, and potentiometric end-point
determination.
The students should be exposed to handling of as many instruments as possible by themselves or under the guidance of a teacher. 3. Interpretation of UV and IR spectra of some unknown intermediates and drugs. (Any two)
Books Recommended: (Latest Edition)

11- Watson, D.G., Pharmaceutical Analysis, A Textbook for Pharmacy Students and Pharmaceutical Chemists, Elsevier Churchill Livingstone. 12- Lee, D.C., Webb, M., Pharmaceutical Analysis, Blackwell Publishing, CRC 13- Willard, H. H., Merrit, L.L., Dean, J. A., Settle P. A., Instrumental Methods of 14- Skoog, D.A., Holler, F.J., Nieman, T.A., Principles of Instrumental Analysis, 15- Christian, G, D., Analytical Chemistry, John Wiley and Sons. 16- Ahuja,S., Rasmussen,H., HPLC method development for Pharmaceuticals, 17- Silverstein, Spectrometric identification of Organic Compounds, Willy. 18- Kemp William, Organic Spectroscopy, Pal grave, New York. 19- Beckett and Stenlake, Practical Pharmaceutical Chemistry, CBS Publishers, New 20- Sethi, P.D., Quantitative Analysis of Drugs in Pharmaceutical Formulations, CBS MPHR- 112 Pharmaceutical Statistics and Computer Applications

Unit- I.

Basic Definitions and Concepts: Variables and Variation, Frequency Distributions and Cumulative
Frequency Distributions, Sample and Population, Measures Describing the center of Date Distributions,
Measurement of the Spread of Date, Coding, Precision, Accuracy and Bias, The Question of Significant
Figures.
Data Graphics: Introduction, the Histogram, Construction and Labeling of Graphs, Scatter Plots
(Correlation Diagrams), Semiloga rithmic Plots, Other Descriptive Figures.
Introduction to Probability The Binomial and Normal Probability Distributions : Introduction,
Some Basic Probability, Probability Distributions, the Binomial Distribution, Continuous Data
Distributions, Other Common Probability Distributions.
Unit- II
Choosing Samples:
Introduction, Random Sampling, Other Sampling Procedures: Stratified,
Systematic, Cluster Sampling, Sampling in Quality Control.
Statistical Inference: Estimation and Hypothesis Testing: Statistical Estimation (Confidence
Intervals), Statistical Hypothesis Testing, Comparison of Variances in Independent Samples, Test of
Equality of More than Two Variances confidence limits for variance Tolerance Intervals.
Sample Size and Power: Introduction, Determination of Sample Size for Simple Comparative
Experiments for Normally Distributed Variables, Determination of Sample Size for Binomial Tests,
Determination of Sample Size to Obtain a Confidence Interval of Specified Width, Power, Sample Size
and Power for More than Two Treatments, Sample Size for Bioequivalence Studies.
Unit- III
Linear Regression and Correlation:
Introduction, Analysis of Standard Curves in Drug Analysis:
Application of Linear Regression, Assumptions in Tests of Hypotheses in Linear Regression, Estimate
of the Variance: Variance of Sample Estimates of the Parameters, A Drug Stability Study: A Second
Example of the Application of Linear Regression, Confidence Intervals in Regression Analysis,
Weighted Regression, Analysis of Residuals, Nonlinear Regression Correlation, Comparison of
Variances in Related Samples.
Analysis of Variance: One- Way Analysis of Variance Planned Versus a Posteriori (Unplanned)
Comparisons in ANOVA, Another Example of One- Way Analysis of Variance: Unequal Sample Sixes
and the Fixed and Random Models, Two-Way Analysis of Variance (Randomized Blocks), Statistical
Models, Analysis of Covariance, ANOVA for pooling regression lines as related to stability data.
Factorial Designs : Definitions Two Simple Hypothetical Experiments to Illustrate the Advantages of
Factorial Designs, Performing Factorial Experiments: Recommendations and Notation, A Worked
Example of a Factorial Experiment, Fractional Factorial Designs.



Unit- IV
Transformations and Outliers:
Transformations, Outliers
Experimental Design in Clinical Trials: Introduction, Some Principles of Experimental Design and
Analysis, Parallel Deign, Crossover Designs and Bioavailability / Bioequivalence Studies, Repeated
Measures (Split- Plot) Designs, Multiclinic Studies, Interim Analyses.
Quality Control: Introduction, Control Charts, Acceptance Sampling and Operating Characteristic
Curves, Statistical Procedures in Assay Development, Establishing In- House Limits, Some Statistical
Aspects of Quality and the “Barr Decision”, Important QC Tests for Finished solid Dosage Forms
(Tablets and Capsules), Out of Specification (OOS) Results.
Validation: Process Validation, Assay Validation.

Unit- V
Nonparametric Methods:
Data Characteristics and an Introduction to Nonparametric Procedures, Sign
Test, Wilcoson Signed Rank Test, Wilcoxon Rank Sum Test (Test for Differences Between Two
Independent Groups), Kruskal- Wallis Test (One- Way ANOVA), Friedman Test (Two- WAY Analysis
of Variance), Nonparametric Analysis of Covariance, Runs Test for Randomness, Contingency Tables,
Non Parametric Tolerance Interval.

Optimization Techniques and Screening Designs:
Introduction, Optimization Using Factorial
Designs, Composite Designs to Estimate Curvature, The Simplex Lattice, Sequential Optimization.

Applications of Computers in Pharmaceutical Sciences
Computer Intensive Methods:
Monte Carlo Simulation, Bootstrapping
Book Recommended:

7. Bolton, S and Bon, C, Pharmaceuticals Statistics- Practical & Clinical Applications,
8. Fisher, R.A., Statistical Methods for Research Works, Oliver & Boyd, Edinburgh.
9. Chow, Statistical Design and Analysis of Stability Studies, Marcel Dekker, New
10. Buncher, Statistics in the Pharmaceutical Industry, Marcel Dekker, New York.
11. William E. Fassett, Computer Application in Pharmacy.
12. Ekins, S., Computer Application in Pharmaceutical Research & Development, Wiley.
MPHR- 113 DRUG REGULATORY AFFAIRS & INTELLUCTUAL PROPERTY RIGHTS
A. Drug Information
Introduction
Primary, Secondary & Tertiary Literature
Spectrum of information, finding and managing Drug Information.
B. Drugs and Cosmetics Act and rules with special reference to schedule M and Y.
Unit- II
International Drug Regulatory affairs- registration procedure (Pharmaceutical products) for International
Marketing, Including preparation of dossiers SMF, Validation, Calibration and other documents like
product development, stability data for different countries.

Unit- III
Facilities for manufacturing pharmaceutical products qualifying.
CGMP requirements - 21 CFR parts 210 and 211, Orange Guide, TRS, ICH, etc.
Unit- IV
Facilities for quality control lab qualifying GLP requirements, facilities for warehouse qualifying GWP
requirements.
Unit- V
Intellectual property rights, patents Act, Trademark and Copyright Act
Books Recommended:
15. Gennaro A.R., Remington- The science and practice of pharmacy, Lippircott, Williams & Wilkins.
16. Banker G.S., Rhodes C.T., Modern Pharmaceutics, Marcel Dekker.
17. Malik Vijay, Drug & Cosmetics Act, 1940, Eastern Book Company, Lucknow.
18. Guarino R.A., New Drug Approval Process, Marcel Dekker.
19. Sharma P.P., How to practice GMP, Vandana Prakashan, New Delhi.
20. Sharma P.P., how to practice GLP, Vandana Prakashan, New Delhi,
21. World Health Organization, quality assurance of Pharmaceuticals I & I, Pharma Book Syndicate,
22. Weinlerg S., Good Laboratory Poactices, Marcel Dekker.
23. The Patent Act, 1970
24. The Trade Marks Act, 1999.
25. The Copyright Act, 1958.
26. Potdar M.A., Current Good Manufacturing Practices for Pharmaceuticals, Pharma Med Press,
27. Rick N.G., Drug from Discovery to Approval, Wiley Black Well.
28. Swarlbrick J., Boylan J., Encyclopedia / Pharmaceutical Technology Relevant Welesites of
Regulatory Anthoriter of different countries. MPHR- 115 PRODUCT DEVELOPMENT- I
A study of the Indian pharmaceutical industry vis- a vis global scenario. Stages in product development - flow chart. Unit- III
Formulation additives, drug excipient interactions and incompatibilities. Acceptance criteria of the final product. Pediatric and geriatric aspects of formulations. Development of suitable formulations, basis of selection of excipients. Stability testing – stress testing of drug substances, stability indicating assays. Role of kinetic studies. Stability testing protocols, retest period/ shelf life determination, Photo Stability Testing, Stability testing of biotechnological and phytopharmaceuticals, post approval changes. Books Recommended
1. The drug Development Hand book series, part 1 & 2 Locum House 2. Bankers & Rhodes , Modern Pharmaceutics”, Marcel Dekker. 3. Swarbrick James & Boylan J.C. “ Encyclopedia of pharmaceutical 4. Lachman, Leon, . Lieberman H.A, Kanig J. L., The theory & practice of industrial pharmacy”, Varghese Publication House, Bombay. 5. Rowe R.C., Sheskey P.J., & Owen S.C., “ Handbook of Pharmaceutical Excipients” Pharmaceutical Press, London. 6. .Aulton M.E , Pharmaceut ics: The design & manufacture of medicine , 7. .Ansel H.C, Allen L.V.,.Popovich N.G, “Pharmaceutical Dosage forms and drug delivery systems” , Indian edition, Lippincott Williams & Wilkins, 8. .Carstensen, J.T, Rhodes C.T. “Drug stability”, Marcel Dekker. 9. Wise D.L., “Handbook of Pharmaceutical Controlled release technology 13. .Weiner M.L, Kotkoskie L.A., Excipient Toxicity & Safety, , Marcel 14. .Guarino R.A, New Drug Approval process: the global challenge Marcel 15. Rodriguer A.D. Drug- drug interaction, Marcel Dekker 16. Dressman J & Kramer J. Pharmaceutical Dissolution testing, Taylor & 17. Blaisdell Peter Twenty first century Pharmaceutical development , MPHR- 115 P

SEMESTER - II

MPHR- 124 PRODUCT DEVELOPMENT- II
Pilot Plant Technique, Processes Validation Unit-II -
Unit-III - Technology Transfer
Unit-IV - Materials Management
Books Recommended
1. Lachman Leon,. Lieberman H.A, Kanig J. L. The theory & practice of industrial pharmacy”, Varghese Publication House, Bombay. 2. Levin Michael Pharmaceutical process scale- up , Marcel Dekker. 3. Williams R.O., Taft D.R, Mc- Conville ., J.T. Advanced drug formulation design the optimize therapeutic outcomes , Marcel Dekker 4. Banker & Rhodes Modern Pharmaceutics”, Marcel Dekker . 5. Nash Robert A, Wachter, A.H Pharmaceutical Process Validation., Marcel Dekker . 6. d’Spouts, J.F Automation & validation of information in pharmaceutical processing., 7. Swarbrick J. & Boylan J.C., Encyclopedia of Pharmaceutical Technology, Marcel MPHR – 125 BIOPHARMACEUTICS AND PHARMACOKINETICS
Introduction to BCS classification of drugs. Gastrointestinal absorption of drugs- Biologic, Physicochemical consideration and
Drug distribution, drug binding in blood and tissues.
Drug metabolism and excretion.
§ Pharmacokinetics: compartment models - one compartment & multi compartment • Non compartmentl & non linear Pharmacokinetics Unit- III
Pharmacokinetic Variability – Body weight, Age, Sex, Genetic factors, Disease and Drug Bioavailability Introduction, measurement and enhancement, in vitro dissolution & in
vivo bioavailability ( In vitro – in vivo correlation) bioavailability and bioequivalence studies- protocol and regulatory requirement. Dosage regimens - repetitive dosing and dose adjustments in renal and hepatic failure. Individualisation and optimization of drug dosing regimens. Books Recommended
Shargel Leon Applied Biopharmaceutics & Pharmacokinetics, McGraw- Hill. Notari R. E., Biopharmaceutics and Clinical Pharmacokinetics, an introduction, Marcel Gilbaldi M and Perrier D, Pharmacokinetics, Marcel Dekker. Venkateshwaralu v, Biopharmaceutics & Pharmacokinetics, Pharma Book Syndicate. Gilbadi M, Biopharmaceutics and clinical Pharmacokinetics, Pharma Book Rowland & Tozer, Clinical Pharmacokinetics- Concept and application, Waverly Welling P.G., Tse F.L., Pharmaceutical Bioequivalence, Marcel Dekker. MPHR - 125P
PRACTICAL
Experiments Based on:
A. Permeability measurement of drugs using artificial and biological membranes. B. Determination of Pharmacokinetics parameters from urinary execretion data. C. Determination of Pharmacokinetic parameters from animal experimentation / D. Determination of relative and absolute bioavailability from animal experimentation / E. In vitro dissolution studies of different formulation and study of different factors MPHR – 126 ADVANCES IN DRUG DELIVERY SYSTEMS
Polymers- Definition, Classification and Characterisation, Biodegradable and non biodegradable polymers – properties and applications. A) Controlled Drug Delivery System – Concept and system design, classification:- rate preprogrammed activation modulated, feedback regulated. B) Formulation and evaluation of controlled release systems.– oral, dental and parenteral Unit- III
Factors influencing delivery, formulation and evaluation of – Transmucosal, Gastroretentive and colonic drug delivery system. Transdermal Drug Delivery systems- factors influencing transdermal delivery, formulation and evaluation lonophoresis and Iontophoresis. Target oriented drug delivery systems- prodrugs, Liposomes, Niosomes, Microparticles, Nano particles, anti bodies, cellular carriers, activated carbon, lipoproteins, hormones dextran and other polysaccharides, Synthetics polymers, DNA, Glycoprotein Low Books Recommended:
1. Chien Y.W., Novel Drug Delivery Systems, Marcel Dekker 2. Robinson J.R. and Lee V.H., Controlled Drug Delivery: Fundamentals & 3. Tse F.L.S. and Jaffe J.J., Biodegradable Polymers as Drug Delivery Systems, 4. Banker G.S., Rhodes C.T., Modern Pharmaceutics, Marcel Dekker. 5. Wise D.L., Handbook of Pharmaceutical Controlled Release Technology, Marcel 6. Guy R.H., Hadgraft J., Transdermal Drug Delivery, Marcel Dekker. 7. Rathbone M.J., Hadgraft J., Modified Release Drug Delivery Technology, Marcel 8. Swarbrick J. & Boylan J.C., Encyclopedia of Pharmaceutical Technology, Marcel
MPHR – 126 P

Practicals on Formulation and Evaluation of Drug Delivery Systems
mentioned theory syllabus.

MPHR 120 SYNOPSIS OF THE PROPOSED PROJECT

SEMESTER - III
MPHR 231 EVALUATION OF PROJECT WORK AFTER SIX MONTHS
SEMESTER- IV
MPHR 241 THESIS
MPHR 242 PRESENTATION & VIVA- VOCE
STUDY AND EVALUATION SCHEME

Course: M. Pharm. (Pharmacology) Effective From Session 2009- – 10
SEMESTER - I

(hours/week)
Course Code
MPHR- 111
Pharmaceutical Statistics & Computer MPHR- 112
Drug Regulatory Affairs & Intellectual Property MPHR- 113
MPHR- 116
PRACTICAL
Day to Day Evaluation
MPHR- 111 P
MPHR- 116 P
T- Theory, P- Practical, IA- Internal Assessment, ESE- End Semester Examination
Note: Duration of ESE – Theory exam will be of 3 hours and Practical exam of 8 hours
STUDY AND EVALUATION SCHEME

Course: M. Pharm. (Pharmacology)
SEMESTER - II

(hours/week)
Course Code
Pharmacology- II (Basic Principles of Drug MPHR- 127
MPHR- 128
Pharmacology & Pharmaceutical Medicine) MPHR- 129
Pharmacological Methods & Toxicology MPHR- 120
PRACTICAL
Day to Day Evaluation
MPHR- 128 P
MPHR- 129 P
T- Theory, P- Practical, IA- Internal Assessment, ES E- End Semester Examination
Note: Duration of ESE – Theory exam will be of 3 hours and Practical exam of 8 hours
STUDY AND EVALUATION SCHEME
Course: M.Pharm (Pharmacology)
Semester-III
Course Code
MPHR- 231
Evaluation of Project Work after Six Months STUDY AND EVALUATION SCHEME
Course: M.Pharm (Pharmacology)
Semester-IV
Course Code
MPHR- 241
MPHR- 242
SEMESTER - I
ADVANCED ANALYTICAL TECHNIQUES

Unit –I:
UV-Visible spectroscopy
- Introduction, factors governing absorption of radiation in the UV/visible
region, Beer-Lambert Law and its deviation, chromophore concept, Woodward-Fieser rule,
Instrumentation and instrument calibration, Diode array instruments. Study of UV spectra of some
representative drug molecules. Application in determination of pKa values, pharmaceutical quantitative
analysis, preformulation and formulation. Difference spectrophotometry, derivative spectra.
Solid State Analysis: X-ray diffraction and crystallography, thermal analysis and calorimetry,
micromeritic measurements.

Unit –II:
Infrared spectroscopy
- Introduction, Molecular vibrations, factors influencing vibrational frequencies,
Instrumentation and instrument calibration, sample preparation techniques. Application in structure
elucidation and in identifying polymorphs. I R as a fingerprint technique. Near IR analysis and its
applications, FTIR.

Unit –III:

a) Atomic spectrophotometry:
Atomic emission spectrophotometry: principle, instrumentation, interferences and applications.
Atomic absorption spectrophotometry: principle, instrumentation and applications.

b) Molecular emission spectroscopy :
Fluorescence spectroscopy: Principles, molecules exhibiting fluorescence, factors interfering with
fluorescence intensity, application.
Raman spectroscopy: Principle, instrumentation and applications.

Unit –IV:

a) Nuclear Magne tic Resonance Spectroscopy :
Introduction, instrumentation, chemical shifts, shielding and deshielding effects, spin-spin coupling,
reference standard and solvents, proton NMR, carbon-13 NMR and 2D NMR spectra. Application to
structure confirmation and quantitative analysis.

b) Mass Spectrometry:
Principle, instrumentation, mass spectra obtained under electron impact (EI) ionization conditions,
molecular fragmentation patterns, molecular ion, metastable ion, McLafferty rearrangement, EI mass
spectra of some drug molecules.
GC-MS and LC-MS: principle and applications.

Unit –V:

Chromatographic techniques:
Chromatographic Theory: void volume, capacity factor, band broadening, calculation of column
efficiency, parameters used in evaluating column performance (resolution and peak asymmetry). HPLC:
instrumentation, stationary phases, mobile phases and its selection, columns and detectors, applications
in quantitative analysis of drugs in formulations, specialized HPLC techniques. HPTLC, GC, High-
performance capillary electrophoresis: principle, instrumentation and application.


MPHR – 111P
Practicals
1.
Combination Drug Analysis (Any Five)
a. Vitamins b. Oral antidiabetics c. NSAIDs d. Antimicrobials e. Antihistamines f. Antihypertensive 2. Illustrations of theoretical principles using assay of drugs official in various pharmacopoeias (Any
10). This should cover titrimetric, spectro-photometric (including flamephotometric) methods, HPLC
etc. The titrimetric methods should include argentometric, conductometric, and potentiometric end-point
determination.
The students should be exposed to handling of as many instruments as possible by themselves or under the guidance of a teacher. 3. Interpretation of UV and IR spectra of some unknown intermediates and drugs. (Any two)
Books Recommended: (Latest Edition)

21- Watson, D.G., Pharmaceutical Analysis, A Textbook for Pharmacy Students and Pharmaceutical Chemists, Elsevier Churchill Livingstone. 22- Lee, D.C., Webb, M., Pharmaceutical Analysis, Blackwell Publishing, CRC 23- Willard, H. H., Merrit, L.L., Dean, J. A., Settle P. A., Instrumental Methods of 24- Skoog, D.A., Holler, F.J., Nieman, T.A., Principles of Instrumental Analysis, 25- Christian, G, D., Analytical Chemistry, John Wiley and Sons. 26- Ahuja,S., Rasmussen,H., HPLC method development for Pharmaceuticals, 27- Silverstein, Spectrometric identification of Organic Compounds, Willy. 28- Kemp William, Organic Spectroscopy, Pal grave, New York. 29- Beckett and Stenlake, Practical Pharmaceutical Chemistry, CBS Publishers, New 30- Sethi, P.D., Quantitative Analysis of Drugs in Pharmaceutical Formulations, CBS MPHR- 112 Pharmaceutical Statistics and Computer Applications

Unit- I.

Basic Definitions and Concepts: Variables and Variation, Frequency Distributions and Cumulative
Frequency Distributions, Sample and Population, Measures Describing the center of Date Distributions,
Measurement of the Spread of Date, Coding, Precision, Accuracy and Bias, The Question of Significant
Figures.
Data Graphics: Introduction, the Histogram, Construction and Labeling of Graphs, Scatter Plots
(Correlation Diagrams), Semilogarithmic Plots, Other Descriptive Figures.
Introduction to Probability The Binomial and Normal Probability Distributions : Introduction,
Some Basic Probability, Probability Distributions, the Binomial Distribution, Continuous Data
Distributions, Other Common Probability Distributions.
Unit- II
Choosing Samples:
Introduction, Random Sampling, Other Sampling Procedures: Stratified,
Systematic, Cluster Sampling, Sampling in Quality Control.
Statistical Inference: Estimation and Hypothesis Testing: Statistical Estimation (Confidence
Intervals), Statistical Hypothesis Testing, Comparison of Variances in Independent Samples, Test of
Equality of More than Two Variances confidence limits for variance Tolerance Intervals.
Sample Size and Power: Introduction, Determination of Sample Size fo r Simple Comparative
Experiments for Normally Distributed Variables, Determination of Sample Size for Binomial Tests,
Determination of Sample Size to Obtain a Confidence Interval of Specified Width, Power, Sample Size
and Power for More than Two Treatments, Sample Size for Bioequivalence Studies.
Unit- III
Linear Regression and Correlation:
Introduction, Analysis of Standard Curves in Drug Analysis:
Application of Linear Regression, Assumptions in Tests of Hypotheses in Linear Regression, Estimate
of the Variance: Variance of Sample Estimates of the Parameters, A Drug Stability Study: A Second
Example of the Application of Linear Regression, Confidence Intervals in Regression Analysis,
Weighted Regression, Analysis of Residuals, Nonlinear Regression Correlation, Comparison of
Variances in Related Samples.
Analysis of Variance: One- Way Analysis of Variance Planned Versus a Posteriori (Unplanned)
Comparisons in ANOVA, Another Example of One- Way Analysis of Variance: Unequal Sample Sixes
and the Fixed and Random Models, Two-Way Analysis of Variance (Randomized Blocks), Statistical
Models, Analysis of Covariance, ANOVA for pooling regression lines as related to stability data.
Factorial Designs : Definitions Two Simple Hypothetical Experiments to Illustrate the Advantages of
Factorial Designs, Performing Factorial Experiments: Recommendations and Notation, A Worked
Example of a Factorial Experiment, Fractional Factorial Designs.



Unit- IV
Transformations and Outliers:
Transformations, Outliers
Experimental Design in Clinical Trials: Introduction, Some Principles of Experimental Design and
Analysis, Parallel Deign, Crossover Designs and Bioavailability / Bioequivalence Studies, Repeated
Measures (Split- Plot) Designs, Multiclinic Studies, Interim Analyses.
Quality Control: Introduction, Control Charts, Acceptance Sampling and Operating Characteristic
Curves, Statistical Procedures in Assay Development, Establishing In- House Limits, Some Statistical
Aspects of Quality and the “Barr Decision”, Important QC Tests for Finished solid Dosage Forms
(Tablets and Capsules), Out of Specification (OOS) Results.
Validation: Process Validation, Assay Validation.

Unit- V
Nonparametric Methods:
Data Characteristics and an Introduction to Nonparametric Procedures, Sign
Test, Wilcoson Signed Rank Test, Wilcoxon Rank Sum Test (Test for Differences Between Two
Independent Groups), Kruskal- Wallis Test (One- Way ANOVA), Friedman Test (Two- WAY Analysis
of Variance), Nonparametric Analysis of Covariance, Runs Test for Randomness, Contingency Tables,
Non Parametric Tolerance Interval.

Optimization Techniques and Screening Designs:
Introduction, Optimization Using Factorial
Designs, Composite Designs to Estimate Curvature, The Simplex Lattice, Sequential Optimization.

Applications of Computers in Pharmaceutical Sciences
Computer Intensive Methods:
Monte Carlo Simulation, Bootstrapping
Book Recommended:

13. Bolton, S and Bon, C, Pharmaceuticals Statistics- Practical & Clinical Applications,
14. Fisher, R.A., Statistical Methods for Research Works, Oliver & Boyd, Edinburgh.
15. Chow, Statistical Design and Analysis of Stability Studies, Marcel Dekker, New
16. Buncher, Statistics in the Pharmaceutical Industry, Marcel Dekker, New York.
17. William E. Fassett, Computer Application in Pharmacy.
18. Ekins, S., Computer Application in Pharmaceutical Research & Development, Wiley.
MPHR- 113 DRUG REGULATORY AFFAIRS & INTELLUCTUAL PROPERTY RIGHTS
A. Drug Information
Introduction
Primary, Secondary & Tertiary Literature
Spectrum of information, finding and managing Drug Information.
B. Drugs and Cosmetics Act and rules with special reference to schedule M and Y.
Unit- II
International Drug Regulatory affairs- registration procedure (Pharmaceutical products) for International
Marketing, Including preparation of dossiers SMF, Validation, Calibration and other documents like
product development, stability data for different countries.

Unit- III
Facilities for manufacturing pharmaceutical products qualifying.
CGMP requirements - 21 CFR parts 210 and 211, Orange Guide, TRS, ICH, etc.
Unit- IV
Facilities for quality control lab qualifying GLP requirements, facilities for warehouse qualifying GWP
requirements.
Unit- V
Intellectual property rights, patents Act, Trademark and Copyright Act
Books Recommended:
1. Gennaro A.R., Remington- The science and practice of pharmacy, Lippircott, Williams & Wilkins.
2. Banker G.S., Rhodes C.T., Modern Pharmaceutics, Marcel Dekker.
3. Malik Vijay, Drug & Cosmetics Act, 1940, Eastern Book Company, Lucknow.
4. Guarino R.A., New Drug Approval Process, Marcel Dekker.
5. Sharma P.P., How to practice GMP, Vandana Prakashan, New Delhi.
6. Sharma P.P., how to practice GLP, Vandana Prakashan, New Delhi,
7. World Health Organization, quality assurance of Pharmaceuticals I & I, Pharma Book Syndicate,
8. Weinlerg S., Good Laboratory Poactices, Marcel Dekker.
9. The Patent Act, 1970
10. The Trade Marks Act, 1999.
11. The Copyright Act, 1958.
12. Potdar M.A., Current Good Manufacturing Practices for Pharmaceuticals, Pharma Med Press,
13. Rick N.G., Drug from Discovery to Approval, Wiley Black Well.
14. Swarlerick J., Boylan J., Encyclopedia / Pharmaceutical Technology Relevant Welesites of
Regulatory Anthoriter of different countries. MPHR – 116 PHARMACOLOGY – I
SYSTEMIC PHARMACOLOGY
Unit- I.
Basic Principles of Pharmacology:
Mechanisms of drug action, membrane transporters
and drug response, adverse drug reactions, and pharmacokinetics.

Pharmacology of the Autonomic Nervous System:
1.
Neurotransmission: The Autonomic and Somatic Motor Nervous System
2. Muscarinic receptor agonists and antagonists
3. Anticholinesterase agents
4. Agents acting at neuromuscular junction and autonomic ganglia
5. Adrenergic agonists and antagonists drugs used in glaucoma
6. 5-Hydroxytryptamine receptor agonists and antagonists

Unit-11
Drugs acting on the Central Nervous System:

1) Neurotransmission and the Central Nervous System
2) General Anesthetics
3) Local Anesthetics
4) Hypnotics, Sedatives and Ethanol
5) Drugs effective in the therapy of Migr aine
6) Treatment of Central Nervous system degenerative disorders
7) Opioid Analgesics and Antagonists
8) Drug Addiction and Drug Abuse

Autacoids: Drug Therapy of Inflammation:
1)
Introduction
2) Histamine, Bradykinin and their Antagonists
3) Lipid- Derived Autocoids : Eicosanoids and platelet Activating factor
4) Analgesic-Antipyretic and Anti-Inflammatory agents

Unit- 111

Drugs Affecting Renal and Cardiovascular Function:
1.
Diuretics
2. Vasopressin and other agents affecting the renal conservation of water
3. Renin, angiotensin, and their modulators
4. Calcium channel blockers

Drugs Acting on the Blood and Blood-Forming Organs:
Hematopoietic agents: Growth factors, minerals, and vitamins
Blood coagulation and anticoagulant, thrombolytic, and antiplatelet drugs

Unit-1V
Pharmacology of Chemotherapeutic and Antimicrobial Agents:
1.
General considerations of antimicrobial therapy
2. Sulfonamides, trimethoprim, quinolones, other related agents
3. Penicillins, cephalosporins, and other beta- lactam antibiotics
4. Aminoglycosides
5. Protein synthesis inhibitors and miscellaneous antibacterial agents
6. Antifungal agents
7. Antiviral agents (Non-retroviral)
8. Antineoplastic Agents
9. Immunosuppressants, and Immunostimulants

Unit-V
Hormones and Their Antagonists:
1. Pituitatary hormones and their hypothala mic releasing factors
2. Thyroid and antithyroid drugs
3. Estrogens and progestins
4. Androgens
5. Adrenocortical steroids and their synthetic analogs, inhibitors of synthesis and actions

BOOKS RECOMMENDED

1) Modern Pharmcology by C.R. Craig and R.E. Stitzel
2) Goodman and Gilman’s : The Pharmcological Basis of Therapeutics, edited by Alfred
Goodman Gilman, Theodore W. Rall, Alan S Nies, and Palmar Taylor 3) Clinical Pharmcology by D.R. Laurence and P.N. Benett
4) . Essentials of Pharmcotherapeutics by F.S.K. Barar
5) Pharmacology by H.P. Rang and M.M. Dale
6) Lewis’s Pharmacology revised by James Crossland
MPHR 116P PHARMACOLOGY PRACTICALS – I


1. Experiments to study pharmacology of receptors (competitive and non-competitive
antagonists) using guinea pig ileum, and rat colon preprations
2. Experiments to calculate pA2 using isolated rectus abdominus muscle of rat, vas
deferens, muscle of rat, rat colon, and rat fundus preparations.
3 To study the effect of various agonists on isolated guinea pig tracheal chain, isolated
phrenic nervediaphragm, isolated rat aorta, isolated rabbit atria and gastrocnemius muscle
of rabbit
4. Effect of various agents on rat blood pressure.
5. Effect of various pharmacological agents on heart rate, coronary flow rate, and force of
contraction on isolated mammalian heart.
BOOKS RECOMMENDED
1.
Ghosh M.N., Fundamentals of Experimental Pharmacology, Scientific Book Agency,
2 Vogel (ed) H.G., Drug Discovery and Evaluation-Pharmacological Assays, Springer
SEMESTER – II
MPHR – 127 PHARMACOLOGY- II
(RECENT ADVANCES IN PHARMACOLOGY& PHARMACEUTICAL MEDICINE)
Unit-1
1. Molecular Pharmacology: Receptor occupancy and cellular signaling systems
including G- proteins,cyclic nucleotides, calcium and calcium binding proteins,
phospholipases.
Pharmacology of receptors: Classification, cellular signaling systems, and
pharmacology of agonists and antagonists of the following receptor types:
Excitatory Amino Acid receptors
Purinoreceptors
GABA and Benzodiazepine receptors
Neurosteroid receptors
Cannabinoid receptors
Melatonin receptors
Ion Channels and Their Modulators: Classification and biology of
potassium ionic channels, and pharmacology of their modulators
Novel Target Sites: Physiological functions, pharmacological implications, and
therapeuticpotential of the following target sites:
(a) Akt (Protein kinase B)
(b) Caspases
(c) AMP activated protein kinases
(d) Protein kinases
(e) Phosphodiesterases
Unit-11
Neuropeptides:
Biological functions, pharmacological implications, their agonists and
antagonists,and therapeutic potentials of the following neuropeptides:
Neuropeptide Y
Substance P
Cholecystokinin

Transporter Proteins:
Classification and biology of ATP binding cassette (ABC)
transporter superfamily
Multidrug resistance (MDR) proteins
Cystic fibrosis transmembrane regulator (CFTR)

Unit-111
Programmed Cell Death (Apoptosis):
Molecular biology, physiological and
pharmacological implications and therapeutic potentials of apoptosis.

Cytokines and Chemokines:
Classification, physiology, pharmacology, pathological,
and therapeutic implications of various cytokines and chemokines.
Growth Factors: Biology and therapeutic potentials of various growth factors. .
Biology of Vascular Endothelium: Biology of EDRF, EDCF, and EDHF.
Pharmacology of endothelins and nitric oxide. Clinical implications of endothelial
dysfunction.
Unit-1V

Nucleic Acid Therapies: Basic concepts and clinical potentials of gene therapy,
Genomics: Impact of human genome sequence on the discovery of newer
pharmacological agents. Basic concept and applications of bioinformatics in drug
discovery.
Stem Cell Therapeutics: Biology of stem cells and their potentials in various disorders.
Unit-V
Pharmacoepidemiology:
Types, methods, and factors affecting drug utilization,
applications of pharmacoepidemiology in health care and rational use of drugs.
Pharmacovigilance: Definition, scope, and epidemiology of adverse events, product
recall and withdrawal of drugs with specific examples, and drug related deaths.
Pharmcoeconomics: Principles, methods, and applications of pharmcoeconomics to
pharmacotherapy and managed health care.

BOOKS RECOMMENDED
1.
Fletcher A.J., Edwards L.D., Fox A.W., Stonier P. (eds.), Principles and Practice of
Pharmaceutical Medicine, John Wiley & Sons, Ltd., U.K. 2. Griffin J.P. and O`Grady J. (eds.), The Text Book of Pharmaceutical Medicine,
Blackwell Publishing Ltd., India, 2006.
3. Good P.I., A Managers Guide to Design and Conduct of Clinical trials, Wiley-
Liss, Hobokem, U.S.A.,
2. 5. Dipiro J.T., Talbert R.L., , Yee G.C., Matzke G.R., Wells B.G., Michael L. Posey
(eds.), Pharmacotherapy : A Pathophysiologic Approach, The McGraw Hill Companies, Inc.,
RECOMMENDED REFERENCE JOURNALS

1. Annual Review Pharmacology and Toxicology
2. Drugs
3. Pharmacological Reviews
4. Trends in Pharmacological Sciences
5. Indian Journal of Physiology & Pharmacology
6. Indian Journal of Experimental Biology
7. Indian Journal of Pharmacology
MPHR- 128 PHARMACOLOGY – II
BASIC PRINCIPLES OF DRUG THERAPY AND CLINICAL
PHARMACOLOGY
Definition, Scope, Organization and growth of Clinical Pharmacology, Cellular
Transduction Mechanisms, Monitoring of Drug Therapy, Adverse Drug Reactions,
Patient Compliance, Paediatric and Geriatric Pharmacology, Drug Interactions, Drug
Therapy during pregnancy and lactation.

Unit – II
Clinical Pharmacokinetics:
Determination and clinical relevance of various
armacokineticparameters. Concept and measurement of bioavailability, bioequivalence,
renal and hepatic clearances.Calculation of loading and maintenance doses and dose
adjustment in renal and hepatic impairments.
Unit- III.
Drug Therapy of Inflammatory Disorders:
Biology of inflammation, pathophysiology and drug therapy of osteoarthritis, rheumatoid
arthritis, and gout
Drug Therapy of Respiratory Diseases:
Pathophysiology and drug therapy of asthma.
Drug Therapy of Gastrointestinal Diseases:
Pathophysiology and drug therapy of peptic ulcers, emesis, irritable bowel syndrome, and
inflammatory bowel disease.
Unit – IV
Drug Therapy of Neurological Disorders:
Pathophysiology and drug therapy of epilepsy, Parkinson's disease, migraine, and
myasthenia gravis.
Drug Therapy of Psychiatric Disorders:
Pathophysiology and drug therapy of anxiety, schizophrenia, Alzheimer’s disease, mood
and sleep
disorders, and memory.
Drug Therapy of Endocrine Disorders:
Pathophysiology and drug therapy of diabetes mellitus, contraception, and infertility.
Drug Therapy of Metabolic and Sexual Disorders:
Pathophysiology and drug therapy of obesity and erectile dysfunction
Unit - V
Drug Therapy of Cardiovascular Disorders:
Pathophysiology and drug therapy of congestive cardiac failure, hypertension, cardiac
arrhythmia, ischemic heart disease, hyperlipidemia, and atherosclerosis
Drug Therapy of Infectious Diseases:
Pathophysiology and drug therapy of tuberculosis, leprosy, HIV and related opportunistic
infections,malaria, amoebiasis, and helminth infections.

BOOKS RECOMMENDED
1.
Dipiro J.T., Talbert R.L., , Yee G.C., Matzke G.R., Wells B.G., L. Michael Posey
Pharmacotherapy : A Pathophysiologic Approach, The McGraw Hill Companies, Inc., . 2. Herfindal E.T. and Gourley D.R, Text Book of Therapeutics: Drug and Disease
Management, Lippincott Williams & Wilkins, USA, 3. Speight T.M. and Holford NHG (ed.), Avery’s Drug Treatment: Principals and
Practice of Clinical Pharmacology and Therapeutics, 4th ed., ADIS Press, Sydney, Australia, 4. Kasper Dennis L., Braunwald Eugene, Fauci Anthony S., Hauser Stephen L., Longo
Dan, Jameson J. Larry and Isselbacher Kurt J., (Eds.), Harrison's Principles of Internal Medicine, , The McGraw Hill Companies, Inc.
MPHR 128 P
PHARMACOLOGY PRACTICALS – I1
1 Bioassays of various agonists and antagonists using guinea pig ileum, rat
uterus, rat fundus .e.g.
a.5HT bioassay(Comparative,graphical,4 point)
b.oxytocin bioassay(graphical)
c.Ach bioassay(rat fundus)
d.Histamine bioassay using guinea pig ileum(graphical &4 point)
2.
Exercises to calculate pharmacokinetic parameters, bioavailability and bioequivalence
using serum/plasma and urine excretion data.
BOOKS RECOMMENDED
1. M.N. Ghosh, Fundamentals of Experimental Pharmacology,
Scientific Book Agency, Calcutta, India,
2.Pharmacologica experiments on isolated Preparations by Edinburgh University
Pharmacology Staff.
3.Handbook of Experimental Pharmacology by S.K. Kulkarni,Vallabh Prakashan Delhi.
MPHR – 129 PHARMACOLOGY- IV
Pharmacological methods and Toxicology

Unit- I
Principles of Experimental Pharmacology:
Common laboratory animals in pharmacological research, limitations of animal tests,
alternatives to animal use, anesthetics used in laboratory animals, some standard
techniques used in laboratory animals, euthanasia of experimental animals. Regulations
for the care and use of laboratory animals. In vivo and in vitro experimentation,its
advantages and disadvantages
Unit-11
New Drug Development Process:
Preclinical evaluation:
Pharmacological evaluation of acute, sub acute, and chronic
toxicity studies.
Clinical Evaluation: Justification and purpose, clinical evaluation including phase I, II,
III and IV studies, ethical and legal aspects of clinical trials, methods of randomization,
size, documentation, monitoring and management of clinical trials

Unit- III
PRINCIPLES OF BIOLOGICAL STANDARDIZATION :

a) Statistical treatment of model problems in evaluation of drugs.
b) Methods of biological assay, principles of biological assays with certain
c) Development of new bioassay methods.
ESSENTIALS OF TOXICOLOGY:
a) Physicochemical, Biochemical and genetic basis of toxicity, principles of
b) Guidelines and regulatory agencies – CPCSEA, OECD, FDA, WHO etc.
c) cellular and sub-cellular toxicity hypersensitivity and immune response.
d) Acute poisoning and its treatment


Unit- IV
Pharmacological Techniques to evaluate drugs belonging to following categories.
a)
Cardiovascular pharmacology– Anti-hypertensives, anti-arrythmics, vasodilators and
b) Drugs for neurodegenerative diseases like Parkinsonism, Alzheimers,
c) Respiratory pharmacology – Anti- asthmatics, Anti- allergic and antitussives
d) Reproductive pharmacology – and anti- fertility agents.
e) Analgesics ,anti- inflammatory and antipyretic agent.
f)

Unit- V

a) CNS pharmacology – behavioural and muscle co-ordination, CNS stimulants and depressants, anxiolytics, anti-epileptics and Nootropics b) Gastrointestinal drugs – Anti- ulcer, anti-emetic, anti-diarrhoeal and laxatives.
c) Anti-cancer agents.
d) Drugs for metabolic disorders like anti-diabetic, anti- hyperlipidemic ,antiobesity, e) Screening of free radical scavenging activity.


BOOKS RECOMMENDED
1.
H.G. Vogel (ed), Drug Discovery and Evaluation-Pharmacological Assays, 2nd
edition, Springer Verlag, Berlin, Germany, 2002. 2. M.N. Ghosh, Fundamentals of Experimental Pharmacology, 2nd edition, Scientific
Calcutta, India, 1984.
3. D.R. Laurence and A.L. Bacharach (eds), Evaluation of Drug Activities:
4. Academic Press, London, U.K., 1964.
5. David R. Gross, Animal Models in Cardiovascular Research, 2nd edition, Kluwer
Academic Publishers, London, U.K., 1994.
MPHR 129P
PHARMACOLOGY PRACTICALS – I11
.
1.Experiments in intact animals to evaluate local anesthetics, mydriatics, miotics,
analgesics,anti- inflammatory agents, hypnotics, antianxiety agents, antiepileptic agents,
antidepressants,antipsychotics, antiparkinsonian agents, nootropics, and antiulcer agents
2. Design and statistical analysis of experimental data.
3.Calculation of LD50 and experiments related to toxicity

BOOKS RECOMMENDED
1. M.N. Ghosh, Fundamentals of Experimental Pharmacology,
Scientific Book Agency, Calcutta, India, .
2 H.G. Vogel (ed), Drug Discovery and Evaluation-Pharmacological Assays, Springer
Verlag, Berlin, Germany,
3.Screening Methods in Pharmacology by turner ,vol.1& 2 ,Academic Press,New York
4.W.W. Daniel, Biostatistics: A Foundation for Analysis in the Health Sciences, 7th ed.,
John Wiley &Sons, Inc., India, 2000.
5. S.P. Gupta, Statistical Methods, 31st ed., Sultan Chand & Sons, India, 2003.

MPHR 120 SYNOPSIS OF THE PROPOSED PROJECT

SEMESTER - III
MPHR 231 EVALUATION OF PROJECT WORK AFTER SIX
SEMESTER- IV
MPHR 241 THESIS
MPHR 242 PRESENTATION & VIVA- VOCE

Source: http://www.dit.edu.in/syllabus/B.%20PHARM/Mpharma_12year.pdf

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