department of pharmacy semester-wise structure for the m

Central University of Rajasthan Department of Pharmacy

Semester-wise structure for the

M. Pharm. in Pharmaceutical Chemistry (MPC) programme Semester I

No. Sub. Code

Title of the Course Type of Course

Credits Contact hours/week

ESE (hour)

Weightage (%)

CIE ESE

C/E/S L I.L P T P ST IA

1. MPC 101

Modern Pharmaceutical Analytical Techniques

C 4 3 1 - 3 - 40 10 50

2. MPC 102

Advanced Organic Chemistry-I C 4 3 1 - 3 - 40 10 50

3. MPC 103

Advanced Medicinal Chemistry-I C 4 3 1 - 3 - 40 10 50

4. MPC 104

Chemistry of Natural Products C 4 3 1 - 3 - 40 10 50

5. MPC 105P

Pharmaceutical Chemistry Lab-I C 3 - - 6 6 - 20 80

6. MPC 106P

Pharmaceutical Chemistry Lab-II C 3 - - 6 6 - 20 80

7. MPC 151

Research Seminar/Assignment-I C 2 - 2 - 1 - - - 100

Total Credits: Semester I–24 Credits

CIE Continuous Internal Evaluation; ESE End Semester Examination; ST Sessional Tests; IA Internal

Assessment, L Lectures, I.L. Integrated Learning involving Tutorials, Group Discussions, Assignments,

Field Work; P Practicals, Lab. work, Project, C Core, E Elective, S Supportive.

The guide will be chosen based on mutual consent of the student and faculty member. After selection of

the research guide the student will formulate his/her Seminar topic (MPC 151).

Semester II

No. Sub. Code



ESE (hour)

Weightage (%)

CIE ESE


1 MPC

201

Advanced Spectral Analysis C 4 3 1 - 3 - 40 10 50

2 MPC

202

Advanced Organic Chemistry-II C 4 3 1 - 3 - 40 10 50

3 MPC 203 Advanced Medicinal Chemistry-II

C 4 3 1 - 3 - 40 10 50

4 MPC 204 Computer Aided Drug Design C 4 3 1 - 3 - 40 10 50

5 MPC 205 MPC 206 MPC 207 MPC 208

Elective Subject Pharmaceutical Process Chemistry Or Basic Molecular Biology Or Advances in Drug Metabolism and Pharmacokinetics Or Drug Evaluation Techniques

E 2 1 1 - 3 - 40 10 50

6 MPC 209P

Pharmaceutical Chemistry Lab-III

C 3 - - 6 - 6 - 20 80

7 MPC 210P

Pharmaceutical Chemistry Lab-IV

C 3 - - 6 - 6 - 20 80

Total Credits: Semester II –24

Semester III

No. Sub. Code Title of the Course Type of Course


ESE (hour)

Weightage (%)

CIE ESE


1 MPC 300 Research Methodology C 2 1 1 - 3 - 40 10 50

2 MPC 301 Drug Regulatory Affairs C 2 1 1 - 3 - 40 10 50

3 MPC 351 Research Seminar-II/Journal Club

C 2 - 2 - 1 - - - 100

4 MPC 303 Research Project C 18 - - - 1 - - - 100

Total Credits: Semester III –24

The full time research work will commence from this Semester. The students will submit progress report

and present seminar(s) based on the progress of his research work that should be attended by all

students in the department, the research guide, the HOD and other faculty of the Department. The

student will be evaluated by all faculty members. The final marks will be the average of the marks given

by the faculty. The progress report should be handed in by the student the next day after the delivery of

the seminar.

*The student is free to opt one audit course of his/her interest, offered by any department of the

University, however, the subject will appear in the Marks Sheet (if examination is qualified), but credits

will not be accumulated.

Semester IV

No. Sub. Code



ESE (hour)

Weightage (%)

CIE ESE


1 MPC 451

Research Seminar-III/Journal Club

C 2 - 2 - 1 - - - 100

2 MPC 403 Research Project C 22 - - - 1 - - - 100*

Total Credits: Semester IV –24

This Semester is devoted totally to research which will culminate in the submission of a thesis. The

student will deliver a pre-submission seminar before submission of his/her thesis at a date and time fixed

by the department, that should be attended by all students in the department, the research guide, the

HOD and other faculty of the Department. The Seminar will be followed by a discussion.

*The theses of the students will be evaluated by all faculty members (for Max. Marks of 70). The final

marks will be the average of the marks given by the faculty (for Max. Marks of 70). The viva-voce will be

conducted by an external examiner (for Max. Marks of 30).

Strong emphasis should be placed on the novelty/IPR aspects of the research work, beside publications

in peer reviewed journals of good impact factors. Students should be encouraged to attend conferences,

seminars where they will present their research work.

Detailed Syllabus Semester I

Course No MPC 101 Title of the Course: Modern Pharmaceutical Analytical Techniques Credits 4

Unit Course Content (Topics) Contact Hours

1.0 Ultraviolet / Visible Spectroscopy and Fluorimetry 5

Energy level and selection rules, effect of substituents, effect of conjugation, conformation and geometry, the Woodward-Fisher rules, the Fisher-Kuhn rules, applications of UV with reference to different electronic systems. Derivative spectroscopy and its applications. Fluorescence and chemical structure, fluorescence intensity, factors affecting fluorescence, instrumentation, comparison of fluorometry with spectrophotometry, applications of fluorimetry in pharmaceutical analysis.

2.0 Infrared Spectroscopy 6

The Hook’s law and calculation of stretching frequencies for different types of bonds and their bond strengths, coupled interactions, hydrogen bonding, examination of infrared spectrum, survey of important functional groups with examples, radiation source, detectors used, sample handling, quantitative applications, qualitative applications with special reference to stereochemical aspects and hydrogen bonding, absorption and reflectance spectroscopy Near-IR spectroscopy, instrumentation, applications, Far Infrared spectroscopy. Introduction to FTIR, instrumentation and its applications.

3.0 Raman spectroscopy 2

Introduction, theory and polarization measurement, rules of selection and polarization, instrumentation, applications in pharmaceutical sciences. Comparison of Infrared and Raman spectra.

4.0 Nuclear Magnetic Resonance Spectroscopy 15

1H-NMR spectroscopy: Magnetic equivalence, failure of the N+1 rule, chemical shifts, local diamagnetic shielding, hybridization effects, magnetic anisotropy, mechanism of spin-spin coupling, the origin of spin-spin splitting, Pascal’s triangle, the coupling constant, protons on oxygen, nitrogen and sulphur, diastereomeric protons, chemical shift reagents, long range coupling, spin decoupling methods, nuclear over Hauser effect.

Correlation NMR spectrometry: introduction to 1H -1H cosy and 1H - 13C cosy and its applications. Introduction and applications of 2D NMR; solid state NMR.

13C-NMR spectroscopy: Introduction, peak assignments, off resonance decoupling, selective proton decoupling; chemical shift equivalence; chemical shifts; spin coupling.

Spectrometry of other important nuclei: Introduction to 15N, 19F, 31P, basic

concepts.

5.0 Electron Spin Resonance Spectroscopy: Introduction, derivative curves, g values, hyperfine splitting, ESR instrumentation, ESR spectra of free radicals, applications.

1

6.0 Mass Spectrometry 6

Basic principle and theory involved; instrumentation, various ion sources, electron impact source, chemical ionization sources, field ionization sources, desorption sources, mass analysers, double focusing, quadripole, time of flight, ion trap analyzer, ionization, fragmentation, rearrangements, mass spectra of representative compounds, recognition of molecular ion peak, metastable peak, isotopic peaks, applications.

7.0 X-Ray Spectroscopy 4

Introduction, production and properties of the X-ray, X-ray emission, X-ray absorption, principles of X-ray diffraction, powder diffraction, X-ray diffraction methods, application of X-ray diffraction technique in pharmaceutical sciences.

8.0 Thermal Analysis 3

Pharmaceutical applications of thermo gravimetric analysis (TGA), differential thermal analysis (DTA), differential scanning calorimetry (DSC) and microcalorimetry, different types of calorimeters and micro calorimeters, advantages of microcalorimetry over DSC.

9.0 Chromatography 12

Gas Chromatography: Gas liquid chromatography, gas solid chromatography,

instrumentation and applications (GC-MS and GC-FTIR). Derivatization as a means of sampling of thermosensitive compounds.

High Performance Liquid Chromatography: Partition, adsorption, ion exchange, size exclusion; pharmaceutical applications of HPLC and LC-MS. Super critical fluid chromatography; brief introduction to HPTLC.

10.0 Optical Rotatory dispersion and Circular Dichroism: Definition, cotton effect and stereochemistry, octet rule and applications.

2

11.0 Electrophoresis (paper, gel, capillary, zone, moving boundary, isoelectric) and Immunological assays (RIA, ELISA and bioluminescence assays)

4

Total 60

Books 1. Spectroscopy, Pavia D. L., Lapman G. M., Kritz G. S., Vyvyan J. R., Brooks/Cole Indian Reprint. 2. Modern NMR Techniques for Chemistry Research, Derome A. E., Pergamon Press. 3. Spectroscopic Methods in Organic Chemistry, Williams D. H., Fleming I., Tata McGraw Hill.

4. Spectrometric Identification of Organic Compounds, Silverstein R. M., Bassler G. C., Morrill T. C., John Wiley. 5. Instrumental Methods of Analysis, Willards, 7thedn., CBS publishers. 6. Pharmaceutical Analysis-Modern Methods-Part B-JW Munson, Volume 11, Marcel Dekker Series

Course No MPC 102 Title of the Course: Advanced Organic Chemistry - I Credits 4


1. Nomenclature and classification of organic compounds and introduction of modern concepts of organic molecules, hybridization of carbon atom, and bonding (sigma and pi bonds).

5

2. Acids and Bases Bronsted and lewis concepts, acidic and basic catalysis, hard and soft acids and bases, effect of structure on the strength of acids and bases, effect of medium on the acidic and basic strength.

5

3. Organic intermediates Carbocations, carbanions, free radicals, carbenes and nitrenes. Their method of formation, stability and synthetic applications.

5

4. Mechanisms and Methods for Determination Thermodynamic requirements for reaction, kinetic requirements for reaction, basicmechanistic concepts, kinetics versus thermodynamic control. Methods for determining mechanisms: a. Non-kinetic: Identification of products, determination of the presence ofintermediate, isolation of an intermediate, detection of an intermediate, trapping of an intermediate and addition of suspected intermediate, study of catalysis,isotopic labelling stereochemical evidences and crossover experiments. b. Kinetic studies: First order reactions, second order reactions, third order reactions,determination of the order of reaction and reversible reactions.

5

5. Stereochemistry Elements of symmetry: Plane of symmetry and center of symmetry, alternating axis of symmetry, simple axis of symmetry. Kinds of molecules displaying optical activity: compounds with a chiral carbon atom, compounds with other quadrivalent chiral atoms, compounds with tervalent chiral atoms suitably substituted adamantanes. Optical isomerism in compounds containing no chiral atom: biphenyls, allenes, compounds with exocylic double bonds, spiranes, chirality due to a helical shape, chirality caused by restricted rotation of other types. Cis-trans isomerism: resulting from double bonds, monocyclic compounds, fused ring systems, out-in isomerism. Enantiotopic and diastereotopic atoms, groups and faces. Chirality and importance of chiral drugs, techniques for preparing chiral drugs (chirality pool, enzymatic transformation and asymmetric synthesis).

15

6. Alkylation of Nucleophilic Carbon, Enolates and Enamines Generation of carbanions by deprotonation, regioselectivity and stereoselectivity in enolate formation, other means of generating enolates, alkylation of enolates, oxygen versus carbon as the site of alkylation, alkylation of aldehydes, esters, amides and nitriles. The nitrogen analogs of enols and enolates enamines and imine anions.

5

7. Additions to Carbon-Carbon Multiple Bonds Addition of hydrogen halides, hydration and other acid-catalyzed additions, oxymercuration, addition of halogens to alkenes, electrophilic substitution alpha to carbonyl groups, addition of allenes and alkynes. Addition at double bonds via organoboranes: hydroboration, reactions of organoboranes, enantioselective hydroboration, hydroboration of alkynes.

5

8. Elimination Reactions E2, E1 and E1cb mechanisms, orientation effects in elimination reactions, stereochemistry of E2 elimination reactions, elimination not involving C-H bonds.

5

9. Aromatic Substitution Reactions Electrophilic aromatic substitution: nitration, halogenation, Friedel-crafts alkylations and acylations. Nucleophilic aromatic substitution: aromatic diazonium ions as synthetic intermediates, substitution by the addition-elimination mechanism, substitution by the elimination-addition mechanism, substituion by the Srn1 mechanism.

5

10. Reduction of Carbonyl and Other Functional Groups Addition of hydrogen: Catalytic hydrogenation. Group III hydride-donor reagents: Reduction of carbonyl compounds, reduction of other functional groups by hydride donors. Group IV hydride donors. Dissolving-Metal reductions: addition of hydrogen, reductive removal of functional groups, reductive carbon-carbon bond formation, reductive deoxygenation of carbonyl groups.

5

Total 60

Books 1. Carey FA and Sundberg RJ. Advanced Organic Chemistry. Part B: Reactions and Synthesis. Plenum

Press, 2. Ernest EI and Samuel H. Stereochemistry of Organic Compounds. John Wiley and Sons, New York.

Latest Edition. 3. Lehr RE and Marchand AP. Orbital Symmetry: A Problem Solving Approach. Academic Press, New

York. Latest Edition. 4. March J. Advanced Organic Chemistry: Reactions, Mechanisms and Structures. John Wiley and

Sons, New York. Latest Edition. 5. Stereochemistry of carbon compounds, Eliel E, Wilen S H, Manden L N, Wiley. 6. Stereochemistry of Organic Compounds, Nasipuri D, Wiley Eastern. 7. Organic Chemistry, Clayden J, Greeves N, Warren S, Wothers P, Oxford University Press. Books

Course No MPC103. Title of the Course: Advanced Medicinal Chemistry-I Credits 4


1.0 Drug Discovery 16

1.1 Historical perspective

1.2 Lead Discovery

1.3 Lead Modification – identification of the pharmacophore, functional group modification, privileged structures and drug-like molecules, modifications to increase potency and the therapeutic index, modifications to increase oral bioavailability.

1.4 Analog Design: Introduction, Classical & Non classical,Bioisosteric replacement strategies, rigid analogs,alteration of chain branching, changes in ring size, ring position isomers, design of stereo isomers andgeometric isomers, fragments of a lead molecule,variation in inter atomic distance.

2.0 Receptors 14

2.1 Basic ligand concepts – agonist, antagonist, partial agonist, inverse agonist, efficiency and potency

2.2 Interactions (Forces) involved in drug-receptor complexes

2.3 Receptor theories – occupancy theory, rate theory and activation theory

2.4 Receptor classification – the four superfamilies

2.5 Receptor binding assays- measurement of Kd, Bmax and IC50

2.6 Topographical and stereochemical considerations in drug –receptor interactions

3.0 Prodrugs and Drug Delivery Systems 16

3.1 Enzyme activation of drugs, utility of prodrugs – aqueous solubility, absorption and distribution, site specificity, instability, toxicity, poor patient acceptability, formulation problems.

3.2 Carrier-linked prodrugs – carrier linkages for various functional groups, carrier-linked bipartite prodrugs, macromolecular drug carrier systems, tripartite prodrugs, mutualprodrugs, bioprecursor prodrugs (hydrolytic activation, elimination activation, oxidative activation, reductive activation, nucleotide activation, phosphorylation activation, sulfation activation and decarboxylation activation).

4.0 Enzymes 14

4.1 Introduction to enzymes, binding site, specificity of enzyme catalyzed reactions and rate acceleration, MichaelisMenten kinetics and methods for plotting enzyme kinetic data

4.2 Mechanisms of enzyme catalysis – covalent catalysis, acid-base catalysis, electrostatic catalysis, some examples of the mechanisms of enzyme catalysis

4.3 Coenzyme catalysis – pyridoxal 5’-phosphate (racemases, decarboxylases, aminotransferases), nictoinamide and flavin (two-electron mechanism, carbanion followed by two one-electron transfers, one-electron mechanism and hydride mechanism), folic acid and thiamine (one carbon transfer reactions).

4.4 Enzyme therapy

Total 60

Books 1. The Organic Chemistry of Drug Design and Drug Action, Silverman R. B., Academic Press. 2. Textbook of Drug Design and Discovery, Eds. Krogsgaard-Larsen P., Liljefors T., Madsen U., Taylor & Francis. 3. Drug Discovery – A History, Sneader W., Wiley. 4. Medicinal Chemistry: An Introduction, Thomas G, Wiley. 5. Drug Discovery – A History, Sneader W, John Wiley & Sons

Course No MPC104. Title of the Course: Chemistry of Natural Products Credits 4


1.0 Natural products in drug discovery 8 1.1 Historical perspective, Natural Products as a Source for Modern Medicinal Chemistry

Compounds, Natural Product Chemical Space, ways of using natural products for drug discovery, optimization of natural product leads, Importance of marine natural products in drug discovery, High Throughput Screening in natural products

2.0 Recent advances in the chemistry and total synthesis of some naturally occurring medicinal agents.

12

3.0 Different extraction methods including solid phase micro-extraction, supercritical fluid extraction, microwave-assisted extraction and ultrasound assisted extraction and comparison with conventional extraction methods,

17

4.0 Introduction to bioassay-guided fractionation of phytoconstituents and its application.

5

5.0 Introduction and applications of various separation techniques in plant drug analysis including vacuum liquid chromatography, flash chromatography, TLC, GC, droplet counter-current chromatography, centrifugal counter-current chromatography, centrifugally accelerated chromatography.

18

Total 60 Books

1. Torseel KBG. Natural Product Chemistry. John Wiley and Sons, New York. Latest Edition. 2. Harborne JB. Phytochemical Methods. Chapman and Hall, London. Latest Edition. 3. Finar IL. Organic Chemistry. The English Language Book Society, London. Latest Edition. 4. Wolff ME. Burger’s Medicinal Chemistry and Drug Discovery, Principle and Practice. John Wiley and Sons, New

York. Latest Edition. 5. Boldi AM. Combinatorial Synthesis of Natural Product Based Libraries. Taylor and Francis, London. Latest Edition. 6. Modern Methods of Plant Analysis-Peach and Tracy, Springer Verlag 7. Practical Evaluation of Phytopharmaceuticals – Brain and Turnetr, Wright Scientechnica 8. Phytochemical techniques, N. Raaman , New India Publishing Agency. 9. Grabley S. and Thiericke R. (Eds.) Drug Discovery form Nature. Springer-Verlag, Berlin Heidelberg. Latest Edition. 10. Kaufman PB, Warber CS, Duke JA and Brielmann HL. (Eds.) Natural Products from Plants. CRC Press, Florida.

Latest Edition. 11. Williamson EM, Okpako DT and Evans FJ. (Eds.) Selection, Preparation and Pharmacological Evaluation of Plant

Material. John Wiley and Sons, New York. Latest Edition. 12. Hostettmann K, Hostettmann M and Marston A. Preparative Chromatography Techniques: Applications in Natural

Product Isolation. Springer-Verlag, Berlin. Latest Edition. 13. Cannell RJP. (Ed.) Natural Products Isolation. Humana Press, Totowa, New Jersey. Latest Edition. 14. Monographs and relevant review articles appearing in various periodicals and journals.

Course No MPC105P. Title of the Course: Pharmaceutical Chemistry Lab - I Credits 3

A number of practicals based on the theory syllabus such as:

1. Analysis of Pharmacopoeial compounds and their formulations by UV Vis spectrophotometer, RNA & DNA estimation

2. Simultaneous estimation of multi component containing formulations by UV spectrophotometry 3. Experiments based on Column chromatography 4. Experiments based on HPLC 5. Experiments based on Gas Chromatography 6. Estimation of riboflavin/quinine sulphate by fluorimetry 7. Estimation of sodium/potassium by flame photometry A number of practicals based on the theory syllabus such as:


1.1 Friedel crafts alkylation: t-butyl alcohol to t-butylchloride to t-butylbenzene

1.3 Friedel crafts acylation: phthalic anhydride to o-benzoylbenzoicacid to anthraquinone

2.1 Wolff Kischner reduction: acetophenone to ethylbenzene

2.2 LAH reduction: cyclohexanone to cyclohexanol

2.3 Oxidation reduction: p-nitrotolune to p-nitrobenzoic acid to p-aminobenzoic acid

Total 90

Course No MPC106P. Title of the Course: Pharmaceutical Chemistry Lab - II Credits 3 A number of practicals based on the theory syllabus such as:


1.1 Hydroquinone to quinone to triacetoxybenzene

1.2 Hydroquinone to hydroquinone diacetate to 2,5-dihydroxyacetophenone

2.1 Napthalene to nitronapthalene to 4-nitronapthylamine

3.1 Mannich reaction of acetophenone

4.1 Anthranilic acid to o-chlorobenzoic acid to N-phenylanthranilic acid to acridone

5.0 Synthesis of heterocycles:

5.1 Aniline to quinoline

5.2 Urea to barbituric acid

5.3 Resorcinol to 7-hydroxy-4-methyl coumarin

5.4 Cyclohexanone to 1,2,3,4-tetrahydrocarbazole

5.5 o-phenylenediamine to benzimidazol

5.6 o-phenylenediamine to benzotriazole

5.7 Benzil to diphenylquinazoline

5.8 Acetylacetone to 3,5-dimethypyrazole

6.0 Grignard reaction, enamine synthesis and its acylation, NaBH4 reduction, hydroboration oxidation, Green synthesis could also be easily incorporated in the practical program

Total 90

Course No MPC 151 Title of the Course: Research Seminar-I/Assignment Credits 2

The student in consultation with his/her research guide will choose a topic related to his/her area of

research and will deliver a Seminar at a date and time fixed by the department, that should be attended

by all students in the department, the research guide, the HOD and other faculty of the Department. The

Seminar will be of 25 minutes duration, followed by a discussion. The student will be evaluated by all

faculty members under the following parameters: coverage of literature, presentation skills, defence and

the seminar report (the report should be handed in by the student the next day after the delivery of the

seminar and a copy of the seminar report should be housed in the department). The final marks will be

the average of the marks given by the faculty.

Semester II Course No MPC201 Title of the Course: Advanced Spectral Analysis Credits 4


1.0 Molecular Formulae, Elemental Analysis and calculation, Determination of molecular mass, Index of Hydrogen Deficiency, Rule of thirteen,Isotopedetection,Nitrogen rule

2

2.0 Analysis of IR spectrum of Organic compounds

10

3.0 UV spectroscopy: Wood ward – Fieser rule for 1,3- butadienes, cyclic dienes and α, β-carbonyl compounds and interpretation compounds of enones. Calcualtion of λmax values by applying these rules

4

4.0 NMR spectroscopy

4.1 Spin Spin coupling: Coupling constants, one bond couplings, two bond couplings, three bond couplings, long range couplings. Magnetic equivalence, Nonequivalence within a group, Measuring coupling constants from first order spectra, mechanisms of coupling in alkenes; allylic coupling, second order spectra: strong coupling, coupling in aromatic and heteroaromatic systems, Homotopic, enantiotopic and diastereotopic systems. Intrepretation of diastereotopic systems.

14

4.2 Other topics in 1-D NMR: Protons on oxygen, exchange in water and D2O, other types of exchange. Protons on nitrogen, effect of solvent on chemical shifts, Chemical shift reagents, chiral resolving agents, spin decoupling methods

4

4.3 Advanced NMR techniques: DEPT, NOESY, COSY and HETCOR, INADEQUATE techniques, MRI.

3

5.1 Mass Spectroscopy Mass fragmentation and its rules, Fragmentation of important functional groups like alcohols, amines, carbonyl groups and alkanes, Meta stable ions, Mc Lafferty rearrangement, Ring rule, Isotopic peaks, Interpretation of organic compounds.

6

6.0 Problems involving structure determination based on UV, IR, NMR and Mass spectra.

17

Total 60

Books

1. Silverstein RM and Webster FX. Spectrometric Identification of Organic Compounds. John Wiley and Sons, New York. Latest Edition.

2. Chatten LG. Pharmaceutical Chemistry, Vol I & II. Marcel Dekker, New York. Latest Edition. 3. James WD and Kenneth HT. Analytical Chemistry by Oipen Learning: Thermal Methods. John

Wiley and Sons, New York. Latest Edition.

4. Abraham RJ, Fisher J and Bftus P. Introduction to NMR Spectroscopy. John Wiley and Sons, New York.

Latest Edition. 5. Pavia DL, Lampman GM and Kriz GS. Introduction to Spectroscopy. Harcourt College

Publishers, Orlando. Latest Edition.

6. Skoog DA, Holler FJ and Nieman TA. Principles of Instrumental Analysis. Harcourt College Publishers, Harcourt Asia. Latest Edition

Course No MPC202 Title of the Course: Advanced Organic Chemistry-II Credits 4 Unit Course Content (Topics) Contact

Hours

1. Reactions of Carbon Nucleophiles with Carbonyl Groups Aldol condensation: The general mechanism, mixed aldol condensation with aromatic aldehydes, control of regiochemistry and stereochemistry of mixed aldol condensation of aliphatic aldehydes and ketones, intramolecular aldol condensations and the robinsons annulation. The Mannich reaction, amine-catalyzed condensation reactions. Acylation of carbanions, the Wittig and related reactions, nucleophilic addition-cyclization.

5

2. Rearrangements 5.1 Carbon to carbon migration: Wagner-Meerwein and related reactions, expansion and contraction of rings, acid catalyzed rearrangements of aldehydes and ketones, dienones-phenol rearrangement, benzil-benzilic acid rearrangement, Favorskii rearrangement, Arndt-Eistert synthesis, homologization of aldehydes and ketones; Neber’s rearrangement. 5.2 Carbon to nitrogen migration: Hofmann rearrangement, Curtius rearrangement, Lossen rearrangement, Schmidt rearrangement, Beckmann rearrangement, Stieglitz and related rearrangements. 5.3 Carbon to oxygen and oxygen to carbon migration: Bayer-Villiger rearrangement, rearrangement of hydroperoxide and Claisen rearrangement. 5.4 Nitrogen to carbon, oxygen to carbon migrations: Steven’s rearrangement, Witting rearrangement.

10

3. Electrocyclic Reactions Concept of molecular orbital symmetry, Woodward and Hoffmann Rules of conservation of orbital symmetry and its application to electrocyclic (Diels-Alder reaction) and sigmatropic reactions (Cope rearrangement, Benzidine rearrangement, Fischer synthesis). Cycloaddition and ene reactions.

5

4. Photochemical Reactions Basic principles of photochemical reactions. Photo-oxidation, photo-addition and photo-fragmentation.

5

5. Catalysis: a. Types of catalysis, heterogeneous and homogenous catalysis, advantages and disadvantages b. Heterogeneous catalysis – preparation, characterization, kinetics, supported catalysts, catalyst deactivation and regeneration, some examples of heterogeneous catalysis used in synthesis of drugs. c. Homogenous catalysis, hydrogenation, hydroformylation, hydrocyanation, Wilkinson catalysts, chiral ligands and chiral induction, Ziegler‐Natta catalysts, some examples of homogenous catalysis used in synthesis of drugs. Introduction, Classification of organometallic compounds based on

10

hapticityand polarity of the M-C bond. Nomenclature and general characters. Synthesis, stability and decomposition pathways. Transition metal π-complexes with unsaturated organic molecules, carbon monoxide, alkenes, alkynes, allyl, dienes, cyclopentadienyl, arene complexes, preparation, properties, nature of bonding and structural features, important reactions relating to nucleophilic attack on ligands and to organic synthesis. Basic organometallic reactions covering oxidative reactions, migratory reactions, insertions, extrusion, additions, eliminations – their mechanisms and stereochemistry.

6. Retro synthesis

1. Methods of asymmetric synthesis using chiral pool, chiral auxiliaries and catalytic asymmetric synthesis, enantiopure separation and Stereo selective synthesis with examples.

2. Retrosynthesis and its advantages, rules for dissection of molecules, meaning of the term, disconnection, FGI, FGA and synthons, guidelines for the order of events

3. C-X disconnections; C-C disconnections – alcohols and carbonyl compounds; 1,2-, 1,3-, 1,4-, 1,5-, 1,6-difunctionalized compounds

4. Strategies for synthesis of three, four, five and six-membered rings

5

7. Heterocyclic Chemistry:IUPAC nomenclature, Aromatic heterocycles: with five-membered, six-membered rings and with one or two heteroatoms. Synthesis and reactivity

5

8. Green Chemistry:

a. Introduction, principles of green chemistry

b. Microwave assisted reactions: Merit and demerits of its use, increased reaction rates, mechanism, superheating effects of microwave, effects of solvents in microwave assisted synthesis, microwave technology in process optimization, its applications in various organic reactions and heterocycles synthesis

c. Ultrasound assisted reactions: Types of sonochemical reactions, homogenous, heterogeneous liquid-liquid and liquid-solid reactions, synthetic applications

d. Continuous flow reactors: Working principle, advantages and synthetic applications.

5

9. Asymmetric Synthesis

Methods of asymmetric synthesis using chiral pool, chiral auxiliaries and catalytic asymmetric synthesis, enantiopure separation and Stereo selective synthesis with examples.

5

10. Boron chemistry:

Control of chemo-, regio- and stereo-selectivity, rearrangement of alkylboranes, Alkylboranes as organometallic reagents, e.g., 9-BBN, thexylboranes, disiamylborane, chiral boranes- Ipc2BH, IpcBH2, etc.

5

Total 60

Books 1. Stereochemistry of carbon compounds, Eliel E, Wilen S H, Manden L N, Wiley.

2. Stereochemistry of Organic Compounds, Nasipuri D, Wiley Eastern. 3. Advanced Organic Chemistry, Carey FA and Sundberg RJ, Part A and B, Springer 4. Introduction to Green Chemistry, Ryan M. A., Tinnesand M., American Chemical Society (Washington). 5. Organic Chemistry, Clayden J, Greeves N, Warren S, Wothers P, Oxford University Press. 6. Stereoselective Synthesis, Atkinson R S, John Wiley & Sons. 7. Molecular Photochemistry, Turro N J, Publisher W A Benjamin. 8. Pericyclic Reactions, Mukherjee S M, McMillan Press. 9. Heterocyclic Chemistry Joules J. A., Mills K, Blackwell publishing 2008.

Course No MPC203 Title of the Course: Advanced Medicinal Chemistry-II Credits 4


1.0 Enzyme Inhibition 12

1.1 Coverage of basic aspects of enzyme kinetics, catalysis, transition-state theory.

1.2 Reversible enzyme inhibitors – competitive inhibition, non-competitive inhibition, uncompetitive inhibition with suitable examples. Detection of type of inhibition by suitable plotting methods. Concepts of IC50 and Ki.

1.3 Slow-tight binding inhibitors, covalent enzyme inhibitors and mechanism-based inhibitors with suitable examples. Concept of Kinact and Ki for irreversible inhibitors

2.0 Drug Resistance and Drug synergism 05

2.1 Drug Resistance through alterations of drug uptake, overproduction of enzyme, alterations of the enzyme active site, overproduction of the substrate or new pathways for formation of the product

2.2 Drug synergism, concepts and mechanisms.

3.0 DNA-Interactive Agents 12

3.1 Introduction

3.2 DNA Structure and Properties

3.3 Classes of Drugs that Interact with DNA - reversible DNA binders, DNA alkylators, DNA stand breakers

4.0 Discovery, development and mechanistic aspects of selected classes such as antibiotics, anticancer, antiviral, CVS, CNS, and GIT disorders

07

5.0 Peptides and Peptidomimetics 06

5.1 Coverage of peptide structure, biosynthesis of peptides and solid-phase/solution synthesis of peptides.

5.2 Design of peptidomimetics by manipulation of the amino acids, modification of the peptide backbone, incorporating conformational constraints locally or

globally, α-helix, β-sheet, β-and γ-turn mimetics

5.3 Examples of peptidomimetics for some enzymes and receptors like ACE, CCK, bradykinin

6.0 Antisense therapeutic agents 8

6.1 History and principles

6.2 Design of antisense oligonucleotides and small interfering RNAs (siRNAs) with some examples

7.0 Molecular Biology, Genetic engineering and Biotechnology in production of biologicals as drugs.

10

Total 60

Books 1. The Organic Chemistry of Drug Design and Drug Action, Silverman R. B., Academic Press. 2. Textbook of Drug Design and Discovery, Eds. Krogsgaard-Larsen P., Liljefors T., Madsen U., Taylor & Francis. 3. Drug Discovery – A History, Sneader W., Wiley. 4. Medicinal Chemistry: An Introduction, Thomas G, Wiley. 5. Drug Discovery – A History, Sneader W, John Wiley & Sons, Ltd.

Course No MPC204 Title of the Course: Computer Aided Drug Design Credits 4


1.0 2D-QSAR 12

1.1 Historical Aspects

1.2 Electronic Effects- the Hammett equation, lipophilic effects, experimental measurement of lipophilicity, logP and logD, effect of ionization on logP, calculation of logP and logD, Steric effects- the Taft equation

1.3 Hansch Analysis, Free-Wilson method, Topliss operational scheme

1.4 Design of training and test sets using factorial design

2.0 3D-QSAR 6

2.1 CoMFA and CoMSIA. Mention of other 3D-QSAR techniques and introduction to the 4th, 5th and 6th dimension in QSAR.

3.0 Molecular Modeling and Docking

12

3.1 Molecular and Quantum Mechanics in drug design.

3.2 Energy Minimization Methods: comparison between global minimum conformation and bioactive conformation

3.3 Molecular docking and drug receptor interactions: Rigid docking, flexible docking and extra-precision docking. Agents acting on enzymes such as DHFR, HMG-CoA reductase and HIV protease, choline esterase ( AchE& BchE)

4.0 Molecular Properties and Drug Design

4.1 Prediction and analysis of ADMET properties of new molecules and its importance in drug design

15

4.2 De novo drug design: Receptor/enzyme-interaction and its analysis, Receptor/enzyme cavity size prediction, predicting the functional components of cavities, Fragment based drug design.

4.3 Homology modeling and generation of 3D-structure of protein.

5.0 Pharmacophore Mapping and Virtual Screening

15

5.1 Concept of pharmacophore, pharmacophore mapping, identification of Pharmacophore features and Pharmacophore modeling

5.2 Conformational search used in pharmacophore mapping

5.3 In SilicoDrug Design and Virtual Screening Techniques Similarity based methods and Pharmacophore based screening, structure based In-silicovirtual screening protocols

Total 60

Books 1. Computational and structural approaches to drug discovery, Robert M Stroud and Janet. F Moore, RCS Publishers. 2. Introduction to Quantitative Drug Design by Y.C. Martin, CRC Press, Taylor & Francis group. 3. Drug Design by Ariens Volume 1 to 10, Academic Press, 1975, Elsevier Publishers. 4. Principles of Drug Design by Smith and Williams, CRC Press, Taylor & Francis. 5. The Organic Chemistry of the Drug Design and Drug action by Richard B. Silverman, Elsevier Publishers. 6. Medicinal Chemistry by Burger, Wiley Publishing Co. 93 7. An Introduction to Medicinal Chemistry –Graham L. Patrick, Oxford University Press. 8. Wilson and Gisvold’s Text book of Organic Medicinal and Pharmaceutical Chemistry, Ippincott Williams & Wilkins. 9. Comprehensive Medicinal Chemistry – Corwin and Hansch, Pergamon Publishers. 10. Computational and structural approaches to drug design edited by Robert M Strouand Janet. F Moore

Course No MPC209 P Title of the Course: Pharmaceutical Chemistry Lab - III Credits 3 A number of practicals based on the theory syllabus such as:


1.1 Hydroquinone to quinone to triacetoxybenzene

1.2 Hydroquinone to hydroquinone diacetate to 2,5-dihydroxyacetophenone

2.1 Napthalene to nitronapthalene to 4-nitronapthylamine

3.1 Mannich reaction of acetophenone

4.1 Anthranilic acid to o-chlorobenzoic acid to N-phenylanthranilic acid to acridone

5.0 Synthesis of heterocycles:

5.1 Aniline to quinoline

5.2 Urea to barbituric acid

5.3 Resorcinol to 7-hydroxy-4-methyl coumarin

5.4 Cyclohexanone to 1,2,3,4-tetrahydrocarbazole

5.5 o-phenylenediamine to benzimidazol

5.6 o-phenylenediamine to benzotriazole

5.7 Benzil to diphenylquinazoline

5.8 Acetylacetone to 3,5-dimethypyrazole

6.0 Grignard reaction, enamine synthesis and its acylation, NaBH4 reduction, hydroboration oxidation, Green synthesis could also be easily incorporated in the practical program

Total 90

Course No MPC210P Title of the Course: Pharmaceutical Chemistry Lab - IV Credits 3 A number of practicals based on the theory syllabus such as:

Practicals based on computer aided drug design helping in learning techniques of QSAR, Molecular

modeling and docking, Pharmacophore mapping and virtual screening. A number of practicals based on the theory syllabus such as:

Unit Course Content (Topics) Contact

Hours

1.0 Measurement of logP of a poorly water soluble and a highly water soluble drug

2.0 Determination of the pKa of a drug (weak acid and weak base) by potentiometric titration and by UV/visible spectroscopy

3.0 Determination of Km and Vmax for the esterase catalyzed hydrolysis of p-nitrophenyl acetate by plasma esterases. Can also include inhibition of the reaction by paraoxon and determination of IC50

4.0 Estimation of two drugs by simultaneous equation method and by absorbance ratio method.

5.0 Synthesis of some drugs for e.g. thiazide and hydrothiazide derivatives involving multistep reactions.(Students should learn to monitor the reaction by TLC, separate the main product from impurities by column chromatography and learn use of IR and 1H and 13C NMR to check the structures of the intermediates and the final compounds). Comparison of microwave versus conventional synthesis for two different reactions with respect to time requirements and overall yield comparison

6.0 Resolution of racemic mixtures of acidic and basic compounds by formation of diastereomers, e.g. RS-warfarin using (-) brucine

7.0 Synthesis of prodrugs of some common drugs and study of their decomposition (kinetics) to the parent drug

8.0 Separation of drug and metabolites from plasma/urine. e.g. if volunteers are given coumarin and 0-3 hrs urine is collected, it will have both coumarin and 7-hydroxy coumarin (metabolite is present as glucuronide and has to be acid-hydrolysed before HPLC injection)

9.0 Isolation of microsomes from liver tissue by calcium aggregation method. Determination of protein content by Biuret method/Lowry method (BSA as standard), determination of CYP content using CO binding by method of Omura and Sato. Determination of catalytic competence using p-nitrophenol to p-nitrocatechol reaction in presence of NADPH by RP-HPLC. Can also include inhibition of the reaction by antipyrine or SKF-525 or chlorzoxazone.

10.0 Isolation of glutathione S-transferase fraction from liver tissue. Determination of protein content (as above) and assay for 2,4-dichoronitrobenzene-glutathione conjugate formation in the presence of reduced glutathione by following change in absorbance with respect to time. Can also study inhibition of reaction by ethacrynic acid or styrene oxide

11.0 Isolation of crude fraction of xanthine oxidase from rat liver. (involves heat precipitation, solvent fractionation and ammonium sulfate precipitation) and

monitoring xanthine to uric acid formation by UV

Total 90

ELECTIVE SUBJECTS Course No. MPC 205 Title of the Course: Pharmaceutical Process Chemistry Credits 2


Hours

1.0 Process chemistry Introduction, Synthetic strategy Stages of

scale up process: Bench, pilot and large scale process. In-

process control and validation of large scale process. Case

studies of some scale up process of APIs. Impurities in API,

types and their sources including genotoxic impurities

6

2.0 a) Extraction: Liquid equilibria, extraction with reflux,

extraction with agitation, counter current extraction. b)

Filtration: Theory of filtration, pressure and vacuum filtration,

centrifugal filtration, c) Distillation: azeotropic and steam

distillation d) Evaporation: Types of evaporators, factors

affecting evaporation. e) Crystallization: Crystallization from

aqueous, nonaqueous solutions factors affecting crystallization,

nucleation. Principle and general methods of Preparation of

polymorphs, hydrates, solvates and amorphous APIs

15

5.0 Industrial Safety a) MSDS (Material Safety Data Sheet), hazard

labels of chemicals and Personal Protection Equipment (PPE)

b) Fire hazards, types of fire & fire extinguishers c)

Occupational Health & Safety Assessment Series 1800

(OHSAS-1800) and ISO-14001(Environmental Management

System), Effluents and its management

9

Total 30

Books

1. Process Chemistry in the Pharmaceutical Industry: Challenges in an EverChanging Climate-An

Overview; K. Gadamasetti, CRC Press.

2. Pharmaceutical Manufacturing Encyclopedia, 3rd edition, Volume 2.

3. Medicinal Chemistry by Burger, 6th edition, Volume 1-8.

4. W.L. McCabe, J.C Smith, Peter Harriott. Unit operations of chemical engineering, 7th edition,

McGraw Hill

5. Polymorphism in Pharmaceutical Solids .Dekker Series Volume 95 Ed: H G Brittain (1999)

6. Regina M. Murphy: Introduction to Chemical Processes: Principles, Analysis, Synthesis

7. Peter J. Harrington: Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale-

Up

8. P.H.Groggins: Unit processes in organic synthesis (MGH)

9. F.A.Henglein: Chemical Technology (Pergamon)

10. M.Gopal: Dryden’s Outlines of Chemical Technology, WEP East-West Press

11. Clausen,Mattson: Principle of Industrial Chemistry, Wiley Publishing Co.,

12. Lowenheim& M.K. Moran: Industrial Chemicals

13. S.D. Shukla & G.N. Pandey: A text book of Chemical Technology Vol. II, Vikas Publishing House

14. J.K. Stille: Industrial Organic Chemistry (PH)

15. Shreve: Chemical Process, Mc Grawhill.

16. B.K.Sharma: Industrial Chemistry, Goel Publishing House

17. ICH Guidelines

18. United States Food and Drug Administration official website www.fda.gov 97

Course No MPC206 Title of the Course: Basic Molecular Biology Credits 2


1.0 The beginnings of molecular biology 1

2.0 DNA Structure and Role of DNA 7

2.1 Organization of the genome, building from nucleotides to chromatin

2.2 The genetic code and its relationship to protein structure

2.3 DNA replication, Telomere maintenance, mechanisms of DNA repair, DNA recombination

3.0 The versatility of RNA 11

3.1 Transcription and translation in prokaryotes; Transcription and translation in eukaryotes

3.2 Epigenetics and monoallelic gene expression

3.3 RNA processing and post-transcriptional gene regulation

3.4 Mechanisms of translation

4.0 Genetically modified organisms: Use in basic and applied research 9

4.1 Recombinant DNA technology, molecular cloning, & some tools for analyzing gene expression

4.2 Genome analysis: DNA typing; Genomics and beyond; Medical molecular biology: applications in Cancer and Gene therapy; Genes and behaviour

5.0 Plant tissue culture and animal cell culture 2

Total 30

Course No. MPC 207 Title of the Course: Advances in Drug Metabolism and Pharmacokinetics

Credits 2


Hours

1.0 Drug Metabolism 5

1.1 Introduction

1.2 Pathways for drug deactivation and metabolism

2.0 Metabolism, Pharmacokinetics and Toxicity of Functional

Groups

2.1 Drugs and their structural mofits 1

2.2 ADMET for drugs 2

2.3 Amines and their isosters 3

2.4 Carboxylic acids and their bioisosters 5

2.5 Sulphonamide as essential functional group in drug design 5

2.6 Influence of aromatic and heteroaromatic rings on ADME

properties

9

Total 30

Books

1. Comprehensive Medicinal Chemistry, Series Ed., Hansch C., Pergamon Press. 2. Wilson and Gisvold’s, Textbook of Organic Medicinal and Pharmaceutical Chemistry,

Lippincott-Raven 3. Foye’s Principles of Medicinal Chemistry, Lippincott Williams and Wilkins. 4. Drug Metabolizing Enzymes-Cytochrome P450 and Other Drug Metabolizing Enzymes in Drug

Discovery and Development, Lee JS, Obach SR and Fisher MB, Marcel Dekker, Fontis India, 2003 5. Pharmaceutical Profiling in Drug Discovery for Lead Selection, Borchardt RT, Kerns EH, Lipinski

CA, Thakker DR and Wang B, AAPS Press, 2004 6. Drug Metabolism – Current Concepts, Ionescu C and Caira MR, Springer International Edition 7. Handbook of Drug Metabolism, Woolf TF, Marcel Dekker, 1999. 8. Metabolism, Pharmacokinetics and Toxicity of Functional Groups-Impact of Chemical Building

Blocks on ADMET, Dennis A. Smith, RSC Publishing, Latest Edn. Course No. MPC 208Title of the Course: Drug Evaluation Techniques Credits 2


Hours

1.0 Pharmacodynamic models for evaluation of DDS containing

drugs of various categories such as Cardiovascular agents;

Antidiabetic; Antiinflammatory; Antiepileptic; Anticancer;

Hepatoprotectives; Analgesics; Antistress; Antiasthmatic and

CNS active agents etc.

6

2.0 In vitro cell culture techniques for evaluation of drug

permeation from DDS including isolation maintenance of cell

lines, culturing monolayers, evaluation of drug transport.

6

3.0 In vitro / ex vivo models for evaluation of Drug absorption 3

4.0 In vitro cytotoxicity evaluation using cell cultures and

techniques such as MTT assay, Dye uptake etc.

6

5.0 Toxicity testing: In vitro:In vitro toxicity testing and its

application to safety evaluation, General perspectives, in vitro

toxicity trends and issue, Ocular and cutaneous

irritation,Validation of In vitro toxicity tests.

Acute, sub acute and chronic toxicity testing – Biochemical

basis of toxicity, Design of toxicological studies, Quality

assurance in toxicology studies, Toxicity by routes – Parental,

oral, percutaneous and inhalation, Target organ toxicity

exemplified by hepatotoxicity and cutaneous (dermal)

toxicity.

Regulatory status- Ethical, moral and professional issues.

9

Total 30

Books:

1. Bioassay Techniques for drug Development, Atta Ur Rahman, M. Iqbal Choudhary, William J. Thomsen

2. In vitro Methods in Pharmacuetical Research, Edited by J. V. Casterll, M. J. Gomer, Lechon, Academic Press.

3. In Vitro Toxicity Testing by John M. Fraizer 4. General and Applied Toxicology by Bryan Ballantyne, T. Marrs& P. Turner.

Semester III

Course No MPC 300. Title of the Course: Research Methodology Credits 2


1.0 Objectives and purposes of research, types of research (educational, clinical, experimental, basic , applied, patent oriented research) Literature survey: Methods, Objectives and Tools Data Collection and Data Analysis: Types and methods, Application of statistical tools like variance, standard deviation, standard error, mean, t-test, ANOVA, coefficient of correlation and coefficient of determination. Methods and tools of documentation with a special emphasis on computer applications. Report/Thesis and manuscript preparation, contents of report/thesis/manuscript, kinds of abstracts, IMRAD concept, authorship and ethics in medical writing, introduction of plagiarism. Introduction to impact factor, citation analysis, h-index and other metrics.

10

2.0 Laboratory and Biological Safety: Historical background, laboratory protective equipments, primary contaminants of biohazards, biosafety levels for laboratories, regulations and guidelines related to biosafety. Disposal of chemical and carcinogenic waste.

10

3.0 Intellectual Property Rights: Introduction to various kinds of IPRs, need of 10

IPR in pharmaceutical research, introduction to history of important IPR treaties like GATT, WTO, WIPO and TRIPS, introduction to Indian Patent Act 1970, patent filing process in India with a special emphasis on PCT, product patent, process patent, requirements and preparation of patent proposals, registration of patents in foreign countries.

Total 30 Books

1. Pharmaceutical Statistics – Practical and Clinical Applications, Bolton S., Marcel Dekker, Inc. N. Y. USA

2. Biostatistics: A Foundation for Analysis in Health Sciences, Wayne W Daniel, John Wiley & Sons, Inc.

3. Research in Education, Best J. W., Khan J. V., Prentice Hall of India Pvt. Ltd. 4. Thesis and Assignment Writing, Jonathan A., Berry H D., Wiley Eastern Ltd., Bangalore. 5. Writing a Technical Paper, Menzel D. H., McGraw Hill Book Co., Inc. 6. Research Methodology-A step-by-step guide for beginners, Ranjit Kumar, SAGE Publications,

UK. 7. CRC Handbook of Laboratory Safety by Furr A. K.; CRC Press.

Course No MPC 301. Title of the Course: Drug Regulatory Affairs Credits 2

1. Harmonization: Harmonization of regulatory requirements including ICH activity. Regulatory requirements of different regions applicable to pharmaceutical developments, manufacturing, quality control on finished products, extended release products, biopharmaceutical and bioequivalence assessment and good clinical practices and Comparison with regulation in India. Filing of INDA, NDA and ANDA for approval and registration.

8

2. Documentation: Master formula record, Drug master file, distribution records, BoMs. General documentation procedures followed during various stages of formulation developments including the storage of control samples.

7

3. Post Approval Regulatory Affairs: CMC post approval changes, CTD, eCTD, industry and FDA liaison. A comparison between regulatory requirements of CDSCO, EU, MHRA, TGA and ROW countries. Introduction to SUPAC.

8

4. Clinical Trials: Ethics committee (as per ICMR), Types of trials, Clinical trials protocols, Sample size determination, Evaluation of trials, Pharmacovigilance. Stand of CDSCO on clinical trials.

7

Recommended Readings: 1. The Pharmaceutical Regulatory Process, Second Edition, edited by Ira R. Berry and Robert P.

Martin, Drugs and the Pharmaceutical Sciences, Vol. 185, Informa Healthcare Publishers. 2. New Drug Approval Process: Accelerating Global Registrations, Richard A Guarino, 5th edn.,

Drugs and the Pharmaceutical Sciences, Vol. 190, Informa Healthcare Publishers. 3. http://www.ich.org/products/guidelines.html 4. https://clinicaltrials.gov/

Course No:MPC351 Title of the Course: Research Seminar II/Journal Club Credits: 2

The students will do a literature survey for the research work that is to be carried out in Semesters III

and IV and present a Seminar which should cover aspects of literature report, plan of research work,

methodology timelines, and expected outcome of the work before a committee that will constitute the

Research guide, Head of the Department and the other faculty of the Department. The final marks will

be the average of the marks given by the faculty. All the students in the department should attend

seminar.

Course No. MPC 303 Title of the Course: Research Project Credit: 18

The full time research work will commence from this Semester. The students will submit progress report

and present seminar(s) based on the progress of his research work that should be attended by all

students in the department, the research guide, the HOD and other faculty of the Department. The

student will be evaluated by all faculty members. The final marks will be the average of the marks given

by the faculty. The progress report should be handed in by the student the next day after the delivery of

the seminar.

Semester IV

Course No:MPC451 Title of the Course: Research Seminar III/Journal Club Credits: 2 This Semester is devoted totally to research which will culminate in the submission of a thesis. The student will deliver a pre-submission seminar before submission of his/her thesis at a date and time fixed by the department, that should be attended by all students in the department, the research guide, the HOD and other faculty of the Department. The Seminar will be followed by a discussion.

Course No:MPC403 Title of the Course: Research Project Credits: 22

Strong emphasis should be placed on the novelty/IPR aspects of the research work, beside publications

in peer reviewed journals of good impact factors. Students should be encouraged to attend conferences,

seminars where they will present their research work.

*The theses of the students will be evaluated by all faculty members (for Max. Marks of 70). The final

marks will be the average of the marks given by the faculty (for Max. Marks of 70). The viva-voce will be

conducted by an external examiner (for Max. Marks of 30).

department of pharmacy semester-wise structure for the m

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