SHIVAJI UNIVERSITY, KOLHAPUR

Accredited By NAAC

2009

STRUCTURE and SYLLABUS

for

Ph.D. COURSE WORK

(PHARMACY)

Under

FACULTY OF ENGINEERING & TECHNOLOGY

 Ph.D. (Pharmacy) Paper II Subject List

Select any one subject of the following subject with consent of guide

1. Advances in Pharmaceutical Sciences (Pharmacological Screening and Assays)

2. Advances in Pharmaceutical Sciences (Separation Techniques)

3. Advances in Pharmaceutical Sciences (Molecular modelling)

4. Advances in Pharmaceutical Sciences (Isolation And Characterization Of

Phytoconstituents)

5. Advances in Pharmaceutical Sciences (Optimization Technology)

6. Advances in Pharmaceutical Sciences (Biopharmaceuticals)

Paper - II

ADVANCES IN PHARMACEUTICAL SCIENCES

Note: A candidate has to take any one subject with consent of research guide.

ADVANCES IN PHARMACEUTICAL SCIENCES (PHARMACOLOGICAL

SCREENING AND ASSAYS)
Teaching Scheme: Examination Scheme:

Theory: 4 hrs/week Theory Examination: 100 Marks

Unit-1.General principles of screening, correlations between various animal models and human
situations, animal ethics and regulations. Specific use of reference drugs and
interpretation of screening results. Human equivalent dose calculations, animal
equivalent dose calculation.
Unit-2.Pharmacological screening models for therapeutic areas such as hypertension, cerebral
ischaemia, pain, epilepsy, depression, Parkinson’s disease, Alzheimer’s disease and
diabetes.
Unit-3.Pharmacological screening models for infectious diseases.
Unit-4.Correlation between in-vitro and in-vivo screens; Special emphasis on cell based assay,
biochemical assay, radioligand binding assay, high through put screening, high through
put pharmacokinetic analysis.

References:
1. Nodine Siegler, Animal and Clinical Pharmacological Techniques in Drug Evaluation.
2. Turner RA, Screening Methods in Pharmacology, Academic Press, London
3. Goldsteine, Principles of Drug Action, John Wiley and Sons, NewYork
4. Crossland J, Lewis’s Pharmacology, Churchill Livingstone, Edinburgh
5. Goodman and Gilman: Pharmacological Basis of Therapeutics, Pregamon Press, New York.
6. Bacq ZM, Capek, Fundamentals of Biochemical Pharmacology
7. Lawrence DR and Bacharach AL, Evaluation of Drug Activities: Pharmacometrics, Academy
Press, London.
8. Ghosh MN, Fundamentals of Experimental Pharmacology, Scientific Book Agency, Calcutta
9. Kulkarni SK, Handbook of Experimental Pharmacology, Vallabh Prakashan, Delhi
10. Seth UK, Dadkar NK, and Kamat UG: Selected Topics in Experimental Pharmacology,
Kothari Book Depot, Bombay
11. Vogel HG, Drug Discovery and Evaluation, Springer, Germany
12. Drill V. A. Pharmacology in medicine. (McGraw Hill Co. New York)
13. Sarewitz D, Pielke RA Jr: Prediction in Science and Policy. In Prediction: Science, Decision
Making, and the Future of Nature. Edited by Sarewitz D, Pielke RA Jr, Byerly R Jr. Island
Press; 2000:11-22.
14. LaFollette H, Shanks N: Brute Science: Dilemmas of animal experimentation. London and
New York: Routledge; 1996.
15. Kaiser J: Gender in the pharmacy: does it matter? Science 2005, 308:1572.
16. Pound P, Ebrahim S, Sandercock P, Bracken MB, Roberts I: Where is the evidence that
animal research benefits humans?
17. Hau J: Animal Models. In Handbook of Laboratory Animal Science Animal Models. Volume
II. 2nd edition.
18. Wall RJ, Shani M: Are animal models as good as we think? Theriogenology 2008, 69:2-9.
19. Overmier JB, Carroll ME: Basic Issues in the Use of Animals in Health Research. In Animal
Research and Human Health. Edited by Carroll ME, Overmier JB. American Psychological
Association; 2001:5.
20. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance
s/ucm078932.pdf
21. Shanks N, Greek R, Nobis N, Greek J: Animals and Medicine: Do Animal Experiments
Predict Human Response?
22. Houdebine LM: Transgenic animal models in biomedical research.
23. Methods Mol Biol 2007, 360:163-202.
24. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance
s/ucm078932.pdf

ADVANCES IN PHARMACEUTICAL SCIENCES (SEPARATION TECHNIQUES)

Teaching Scheme: Examination Scheme:

Theory: 4 hrs/week Theory Examination: 100 Marks

Unit-1.Chromatography – Principles, retention parameters, stationary phases, separation and

purification methods of Column chromatography, HPLC, vacuum liquid chromatography
(VLC), Gas chromatography, Ion exchange, ion-pair, ion suppression, molecular Sieve
and affinity FPLC. Chiral separation, chiral stationary phases and its application in
pharmaceutical industry.
Unit-2.Detectors for HPLC – types, principles of operation, sensitivity, trouble shooting in
HPLC, maintenance. HPLC method development for ionic and non-ionic compounds,
matrix effect. Sample preparation techniques – Precipitation, Liquid-Liquid extraction,
Solid phase extraction, and microfiltration. Column switching and its applications.
Unit-3.Hypanated Techniques: GC-MS, LC-MS, LC-MS-MS, LC-MS_NMR, LC-MS-IR, LC-
S-IR-NMR.
Unit-4.TLC, HPTLC, over pressure layer chromatography (OPLC), centrifugal chromatography
and Capillary electrophoresis – Theory and principle, retention parameters, classification
and comparative account with respect to HPLC.

References:
1. The Quantitative Analysis of Drugs – D.C. Garratt 3rd Edn. CBS Publishers & Distributors,
New Delhi (2001).
2. Pharmaceutical Drug Analysis – Ashutosh Kar , Minerva Press, New Delhi (2001).
3. Remington – The Science and Practice of Pharmacy, 21 Edn. Lippincott Williams & Wilkins.
4. Wim Kok : Capillary Electrophoresis : Instrumentation and Operation.
5. LC/MS –A Practical User’s Guide by M.Macmaster , John Wily and Sons Inc.
6. Product safety Evaluation HandBook by S.C. Gad, CRC press 1999.
7. Molecular Biomethods Handbook by R. Raphley and J.M. Walker by Humana Press Inc.,
1998.
8. Tandem Techniques(Separation Science Series) by R.P. Scott, John Wily and Sons Inc.
9. Separation Techniques in Chemistry and Biochemistry by R. A. Keller.
10. Bioanalytical Separations, Vol. 4 (Handbook of Analytical Separations) ed., J. D. Wilson,
Elsevier publications.
11. Modern methods of pharmaceutical analysis, Roger E. Schirmer.
 ADVANCES IN PHARMACEUTICAL SCIENCES (MOLECULAR MODELLING)
Teaching Scheme: Examination Scheme:

Theory: 4 hrs/week Theory Examination: 100 Marks

Unit-1.Quantum chemistry and Molecular force fields: Single- and multiple electron systems.
Ab initio- methods, Hartree-Fock equations, gaussian basis sets. Orbitals, calculation of
partial charges, practical program usage. Molecular force fields: Bonds, angles, torsions.
Electrostatics and van der Waals forces, parameterisation from experiments or quantum
chemistry. Effective pair potentials, hydrogen bonds. Computation of molecular
properties and limitations, examples of commonly used force fields. Energy landscapes:
Minimizations, algorithms, normal modes, transition states and reaction pathways.
Unit-2.Bioinformatics: Sequence analysis, protein structure, homology modeling, 3D structure
prediction from sequence, chemoinformatics and combinatorial databases.
Advanced applications: Free energy calculations from simulations, free energy of
solvation, chemical reactions, molecular docking, modern drug design with simulations
and quantum chemistry. Introduction to Protein folding, Experimental techniques for
studying protein folding, Computational methods for studying protein folding.
Unit-3.Introduction to structure and ligand based drug design and Simulation methods:
Pharmacophore model, Homology Model Building, Complementary-based docking,
Molecular-dynamics and Monte-Carlo based docking, Fragment based methods, Build-up
methodology & bridging methodologies with suitable case studies, Molecular dynamics,
equilibration, thermodynamical properties from simulations, stochastic dynamics, energy
conservation, conformational analysis.
Unit-4.Molecular Interactions and Recognition: Electrostastics, VDW interactions,
hydrophobic effect, molecular recognition (binding energy) Inhibitors types:
allosteric, transition state, covalent vs non-covalent, selective and competitive.

References:
1. Leach, A. R. Molecular modelling: principles and applications, 2nd ed., ISBN 0-582-38210-6
2. Charifson P.S (1997) “Practical Application of Computer Aided Drug Design” Dekker, New
York.
3. Computational drug design A Guide for Computational and Medicinal Chemists by David C.
Young, John Wiley & Sons.
4. K.I.Ramachandran, G Deepa and Krishnan Namboori. P.K. Computational Chemistry and
Molecular Modeling Principles and Applications 2008 [1] ISBN 978-3-540-77302-3 Springer-
Verlag GmbH.
5. http://en.wikipedia.org/wiki/Molecular_modelling

ADVANCES IN PHARMACEUTICAL SCIENCES (ISOLATION AND

CHARACTERIZATION OF PHYTOCONSTITUENTS)
Teaching Scheme: Examination Scheme:

Theory: 4 hrs/week Theory Examination: 100 Marks

Unit-1.Extraction techniques such as Soxhlet extraction, microwave extraction, supercritical

fluid extraction, solid phase extraction. Isolation and estimation of Secondary
metabolites- Alkaloids, Glycosides, Tannins, Flavonoids, Polyphenolics, Terpenoids,
Steroids, Organic acids and Proteins.
Unit-2.Isolation and estimation of phytopharmaceuticals:
1) Artimesia -Artimicinine
2) Mapia foetida-Camptothicin
3) Bacopa monnieri-Bacosides
4) Curcuma longa-Curcumin
5) Gymnema sylvestre-Gymnemic acid
6) Mucuna pruriuens –L-Dopa
7) Psoralea corylifolia- Psoralin
8) Taxus baccata-Taxol
9) Tinospora cordifolia- Cordifolioside
Unit-3.Structural elucidation of important phytoconstituents belonging to different groups.
1. Alkaloids –Atropine, Morphine.
2. Glycosides –Strophanthidin.
3. Steroids – Cholesterol.
4. Terpenes – Citral.
Unit-4.Overview of various methods used in characterization including UV, IR, Proton NMR,
C13NMR, Mass spectroscopy and crystallographic characterization. Spectral
characterization of taxol, pinocembrin, curcumin and digoxin.

References
1. Atal, C.K., Kapur, B.M., Cultivation and Utilization of Medicinal and Aromatic Plants,
R.R.L. Jammu.
2. Farooqui, A.A., Sreeramu, B.S., Cultivation of Medicinal and Aromatic Plants University
press, 2001.
st
3. Yoganasimhan, S.N., Medicinal Plants of India, 1 Edition, Interlive Publishing Pvt. Ltd.
4. Medicinal and Aromatic Plant abstracts (MAPA) CSIR, New Delhi.
5. Evans, W.C., Trease and Evans Pharmacognosy, W.B. Saunder & co., London.
6. Wallis, T.E., Text Book of Pharmacognosy.
7. Indian Herbal Pharmacopoeia.
8. Kalia, A.N., Textbook of Industrial Pharmacognosy.
9. Mohammad Ali, Pharmacognosy and Phytochemistry.
10. Bruneton Jean, Pharmacognosy and Phytochemistry of Medicinal Plants.
11. Kaufmann, Natural Products from Plants, CRC Press, New York.
12. Butler, M., Poucher’s Perfumes, Cosmetics and Soaps.
13. Panda, Herbal Soaps and Detergents.
14. Vimladevi, Text Book of Cosmetics.
15. D’Amelio, Botanicals, A Phytocosmetic Desk reference.

ADVANCES IN PHARMACEUTICAL SCIENCES (OPTIMIZATION

TECHNOLOGY)
Teaching Scheme: Examination Scheme:

Theory: 4 hrs/week Theory Examination: 100 Marks

Unit-1.Experiments and optimization process: Design of experiments (DOE) and its need.
Identifying formulation and process variables. How to design experiments. Fundamentals
of optimization process, need, parameters and methods. Understanding of correlation,
linear and non linear regression analysis & mathematical models.
Unit-2.Experimental designs: Design of experiments with special reference to small and large
number of variables. Formulation optimization a case study using Factorial Design, Box
design, Doehiert Hexagon or Uniform Shell design, Mixture design, Simplex Lattice
design, Extreme-Vertices design, Evolutionary methods, D-Optimal, grid search .
Generating contour plot and response surfaces, understanding.
Unit-3.Artificial Inteligence & Expert system: Knowledge components, knowledge
representation schemes, production systems. Expert system tools, Languages, shells, Lisp
Machines and PC based expert system tools. Artificial neuron, Hopfield networks,
Kohenen self organizing maps, adaptive resonance. Schemes of neuro-control,
identification and control of dynamical system, case study.
Unit-4.Optimization of fermentation and extraction processes: Fermentation: Ethyl Alcohol,
Antibiotics, Vitamins, Amino-acids and Pharmaceutical solvents-raw materials, process
and process validation Extraction of phytoceuticals and optimization of the extraction
process.
References:
1. Theory and Practice of Industrial Pharmacy By Lachmann and Libermann. Third edition,
Varghese Publishing House.
2. S. Bolton: Pharmaceutical statistical: Marcel Dekker.
3. Modern Pharmaceutics; By Gillbert and S. Banker.
4. Higgins 1.1., Best, DJ & Jones “ Biotechnology, Principles & Applications” Blackwell
Scientific Publications, Oxford.
5. Stanbary P.F. and Whitaker, A “ Principles of Fermentation Technology” Pergamon
Press, Oxford.
6. Bickerstaff GF. “ Enzymes in Industry and Medicine,New Studies in Biology” Edwin
Arnold, London
7. Klir G.J. and Folger T.A, Fuzzy sets, Uncertainty and Information, PHI
8. Simon Hayking, Neural network, ISA, Research Triangle Parke, 1995.

ADVANCES IN PHARMACEUTICAL SCIENCES (BIOPHARMACEUTICALS)

Teaching Scheme: Examination Scheme:

Theory: 4 hrs/week Theory Examination: 100 Marks

Unit-1.Pharmacotherapeutics of Biopharmaceuticals: Biopharmaceuticals, Definition and

Classification, Vaccines, Monoclonal antibodies, Abzymes, Recombinant Proteins,
Biotherapeutic Proteins. Pharmacokinetics and Pharmacodynamics of Biologicals,
Absorption, Distribution, Protein Binding, Elimination, Proteolysis, Pharmacokinetics of
Oligonucleotides, Immunogenecity and Pharmacogenetic challenge-Pharmacogenomic
variations, Controlled and sustained delivery of drugs, Biomaterials for the sustained
drug delivery, Liposome mediated drug delivery. Drug delivery methods for therapeutic
proteins
Unit-2.Bioprocess Technology and Bioengineering Aspects: Strategies of biopharmaceutical
production using microbiological processes and mammalian cell culture, Operating
considerations for bioreactors for suspension and immobilized cultures, Aeration, mixing
and hydrodynamics in bioreactors, Fed-batch cultivation of mammalian cells for the
production of recombinant proteins, Optimization of high cell density perfusion
bioreactors, Selection, scale-up, operation and control of bioreactors
Unit-3.Recent technologies in optimizing Quality Policies/Processings: Characterization and
Bioanalytical Aspects of Recombinant Proteins as Pharmaceutical Drugs, Blotting
Technique, ELISA technique (Electrochemiluminescence (ECL) - Meso Scale Discovery
(MSD)), PCR, Gel-Permeation chromatography, Size-Exclusion chromatography,
MALDI-TOF analyzers, FACS-calibur, Patent procedures and international protection
Unit-4.Research Advances in Biotherapeutics: Biopharmaceuticals Expressed in Plants,
Strategies of biopharmaceutical discovery using molecular methods like proteomics,
genomics and metabolomics, Biophysical Approaches to stabilize
biopharmaceuticals/protein pharmaceuticals, Lyophilization/freeze drying and Foam
drying technologies to improve stability of proteins, protein engineering, Stem Cell
therapies impact to synthesize new biopharmaceuticals.

References:
1. Pharmaceutical Biotechnology, Drug Discovery and Clinical Applications - O. Kayser and
R.H.Muller., 2004 Wiley-VCH.
2. Biotechnology and Biopharmaceuticals- Rodney J.Y. Ho and Milo Gibaldi., 2003 Wiley-Liss
3. Biopharmaceuticals: Biochemistry and Biotechnology. Gary Walsh. John Wiley and Sons
Ltd., 1998, 2nd Edn.
4. Pharmaceutical Biotechnology. Daan J. A. Crommelin, Robert D. Sindelar. Informa
Healthcare; 3rd Edn.
5. Bioprocess Engineering: Basic Concepts 2nd Edn Schuler and Kargi, 2002 Prentice Hall.
6. Svensson’s course site: http://www.uiowa.edu/~c046138/KINETICS_HOMEPAGE.htm
7. Malcolm Rowland and Thomas N. Tozer, Clinical Pharmacokinetics: Concepts and
Applications, 1995 3rd Edn, Williams & Wilkins, Baltimore.
 Ph.D. (Pharmacy) Paper III Open Elective Subject List

Select any one subject of the following Electives with consent of guide

1. Open elective (Polymorphs And Salts In The Pharmaceutical Industry)

2. Open elective (Chemotherapy of Parasitic and Microbial Infections)

3. Open elective (Synthetic strategies in synthesis of complex organic molecules)

4. Open elective (Clinical Research)

5. Open elective (Spectral Analysis)

6. Open elective (Drug Regulatory affairs)

7. Open elective (Quality Assurance & Quality Control)

8. Open elective (Process Analytical Technology)

9. Open elective (Industrial Pharmacognosy)

Paper – III

OPEN ELECTIVE

Candidate should select any one subject from the following with the recommendation of the
research guide.

OPEN ELECTIVE (POLYMORPHS AND SALTS IN THE PHARMACEUTICAL

INDUSTRY)
Teaching Scheme: Examination Scheme:
Theory: 3 Hrs. per week Uni. Exam: 80 marks
Tutorial: 1 Hr. per week Term Work: 20 Marks

Unit-1.Introduction and relation to Drug Discovery and Development. Polymorphism,

physicochemical properties and bioavailability with appropriate examples.
Unit-2.Salt Selection, Pseudopolymorphs, Hydrates, Solvates, Amorphous Solids.
Unit-3.Analytical Tools for assessment of polymorphism with reference to Process Development
and Formulation Development.
Unit-4.Regulatory Concerns, Patent Implications and uncertainties involved in prediction of
polymorphism.

References:
1. Borka, L., Pharmeuropa, 1995, 7(4), 574 (compiles 200 drugs showing polymorphism).
2. Borka, L., Pharmeuropa, 1995, 7(4), 586 (lists 200 drugs exhibiting polymorphism).
3. Knapman, K., Mod. Drug Discov., 2000, 57.
4. Stahl, H. P., Wermuth, C. G. (Eds.), Handbook of Pharmaceutical Salts: Properties, Selection
and Use, Wiley-VCH, Zurich, 2002.
5. Brittain, H. G., Polymorphism in pharmaceutical solids, in Drugs and the Pharmaceutical
Sciences, Vol. 95, Marcel Dekker, New York, 1999, Chap. 5.
6. www.ich.org. and www.usfda.gov and www.fda.gov/cder/ob/default.htm.
7. Teva Pharma, Sertraline hydrochloride polymorphs, U.S. patent 6,452,054.
8. Teva Pharma, Clopidogrel hydrogensulfate polymorph, WO 03/051362.
9. Gupta, M. K., Van Wert, A., Bogner, R. H., J. Pharm. Sci., 2003, 92, 536.
10. Harper, J. K., Grant, D. M., J. Am. Chem. Soc., 2000, 122, 3708.
11. Lipinski, C. A., Lombardo, F., Dominy, B. W., Feeney, P. J., Adv. Drug Deliv. Rev., 1997,
23, 3.
12. Beckmann, W., Org. Process Res. Dev., 2000, 4, 372.
13. Bauer, J., Spanton, S., Henry, R., Quick, J., Dziki, W., Porter, W., Morris, J., Pharm.Res.,
2001, 18, 859.
14. Chemburkar, S. R., Bauer, J., Deming, K., et al., Org. Process Res. Dev., 2000, 4, 413.
15. Masui, Y., Kituara, Y., Kobayashi, T., Goto, Y., Ando, S., Okuyama, A., Takahashi, H., Org.
Process Res. Dev., 2003, 7, 334.
16. Liebermann, H. A., Lachman, L., Schwartz, J. B., Pharmaceutical Dosage Forms: Tablets,
Vol. 1, Marcel Dekker, New York, 1989, p. 39.
17. Amlodipine maleate vs mesylate, “The Pink Sheet”, July 14, 2003, p. 22.
18. McGlone, in Physics and Chemistry of the Organic Solid States, Fox, D., Labes, M. M.,
Weissberger, A. (Eds.), Interscience, New York, 1965, Vol. 2, p. 725.
19. Desiraju, G. R., J. Indian Chem. Soc., 2003, 80, 151.

OPEN ELECTIVE (CHEMOTHERAPY OF PARASITIC AND MICROBIAL

INFECTIONS)
Teaching Scheme: Examination Scheme:
Theory: 3 Hrs. per week Uni. Exam: 80 marks
Tutorial: 1 Hr. per week Term Work: 20 Marks

Unit-1.Introduction to parasitic and infectious diseases, life cycle of the parasites causing
following infections, immunology of these infectious diseases.
Unit-2.Biology of tuberculosis, amoebiasis, filariasis, leishmaniasis and HIV infection.
Unit-3.Mechanism of action of drugs used in treatment of above infections. Mechanism of drug-
resistance in tuberculosis, leishmaniasis and malaria.
Unit-4.Targets for development of treatment of above infections.

References:
1. Infectious disease secrets, By Robert H. Gates
2. Martin C (2006). "Tuberculosis vaccines: past, present and future". Curr Opin Pulm Med 12
(3): 186–91
3. http://en.wikipedia.org/wiki/Tuberculosis; http://en.wikipedia.org/wiki/Amoebiasis;
http://en.wikipedia.org/wiki/Filariasis; http://en.wikipedia.org/wiki/Filariasis;
http://en.wikipedia.org/wiki/HIV/AIDS.
4. Berger SA, Marr JS. Human Parasitic Diseases Sourcebook. Jones and Bartlett publishers:
Sudbury, Massachusetts, 2006.
5. John P. Overington, Bissan Al-Lazikani and Andrew L. Hopkins, doi:10.1038/nrd2199
Nature Reviews Drug Discovery 5, 993-996 (2006)
6. Hardy LW, Malikayil A. Curr Drug Discov. 2003:15.
7. Shailza Singh, Balwant Kumar Malik, Durlabh Kumar Sharma, Molecular drug targets and
structure based drug design: A holistic approach.
8. Current Medicinal Chemistry AntiInfective Agents (2003).
9. Burger: Medicinal Chemistry, John Wiley & Sons N.Y.
10. Ariens: Medicinal Chemistry Series
11. Bunerworther Progress in Medicinal Chemistry Series
12. Comprehensive Medicinal Chemistry - Series –I – VI (Academic Press)

OPEN ELECTIVE (SYNTHETIC STRATEGIES IN SYNTHESIS OF COMPLEX

ORGANIC MOLECULES)
Teaching Scheme: Examination Scheme:
Theory: 3 Hrs. per week Uni. Exam: 80 marks
Tutorial: 1 Hr. per week Term Work: 20 Marks

Unit-1.Retrosynthetic analysis, disconnections and reliability of reactions, synthons: Donor and

acceptor, functional group interconversions, one group carbon-heteroatom and carbon-
carbon disconnections, chemo- ,region- and stereo-selectivity considerations , natural
reactivity and umpolung. 1, 3 and 1, 5- difunctional compounds.
Unit-2.Principles of synthetic planning : Logic-centered molecular synthesis; Dislocation,
synthetic tree, synthons, logical imposition of boundary conditions, direct associated
approach; structurefunctionality relationships, functionality and unsaturation levels; Polar
reactivity analysis; Control elements, consonant and dissonant circuits; Protocol for
synthetic design.
Unit-3.General synthetic reaction patterns and strategies: Aliphatic nucleophilic and
electrophilic substitutions, aromatic nucleophilic and electrophilic substitutions, addition
to carbon-carbon and carbon- heteroatom multiple bonds, elimination, rearrangements,
 oxidations and reductions. Chemistry of protecting groups: protection for alcohols,
carbonyl groups, carboxylic groups and amino groups.
Unit-4.Chiral synthesis: The chiral pool approach, stereoselective transformation, chiral
auxiliary, chiral catalyst, enzymes as chiral catalysts. Asymmetric synthesis of Ibuprofen,
levofloxacin and esomeprazole.

References:
1. Synthetic organic chemistry, Vol-1, Francesco Nicotra.
2. Reaction Mechanisms in Organic Synthesis, Rakesh Parashar, John Wiley & Sons, 2009.
3. Principles of Asymmetric Synthesis, R.E. Gawley & J. Aub, Elsevier.
4. Ledinicer: Organic Drug synthesis Vol. 1, 2, 3, 4 (John Wiley & Sons N.Y.)
5. Stuart Warren: Organic Synthesis- The Disconnection, approach (John Wiley & Sons)
6. Stuart Warren : Designing Organic Syntheses: A Programmed Introductionto the Synthon
Approach
7. Burger: Medicinal Chemistry (John Wiley & Sons N.Y.)

OPEN ELECTIVE (CLINICAL RESEARCH)

Teaching Scheme: Examination Scheme:
Theory: 3 Hrs. per week Uni. Exam: 80 marks
Tutorial: 1 Hr. per week Term Work: 20 Marks

Unit-1.Clinical Research – Introduction, History, Present & Future Scenario, Drug Development
– Discovery, Screening, Formulation, Preclinical, Various Phases (Phase I to Phase IV)
of Clinical Study, Clinical & Product Registration. BA/BE Studies.
Unit-2.Investigational New Drug & New Drug Application. Regulations – Schedule Y, 21CFR
part 11, 50, 54, 56, 310, 312, Drug Registration: Introduction, U.S regulation, Japan
regulation, U.K regulation, Indian regulation, Ethnic issues in drug Registration. Ethics –
Principles & Practices - History, Ethical Principles, Clinical Trial Regulations,
Declaration of Helsinki, Ethics Committee, Informed Consent, Investigator’s
responsibilities, Vulnerable populations.
Unit-3.Study Setup and monitoring – Feasibility assessment, Site selection, Budget proposal.
Monitoring Responsibilities: Type of monitoring visits, Site Initiation, Interim
Monitoring, Site close out, monitoring activities, Monitoring methods, Problem solving,
Writing monitoring reports. Study Design & Planning – Design, Study Protocol, Case
Report Form, Quality of Life, Study Plan, Study Flow Chart, Investigator Selection,
Clinical Trial Application. Organization – Contracts & Agreements, Liability &
Insurance, Financial Disclosure, Clinical Trial Committees, Logistics & Clinical
Laboratory.
Unit-4.Study Conduct and reporting – Essential Documents, Subject Recruitment,
Randomization & Blinding, Investigational Product Management, Clinical Trial Supplies.
Safety Reporting – Adverse Events, Serious Adverse Events, Adverse Drug Reactions,
Patient Care in Clinical Research, Pharmacovigilance. Study Report – Interpretation,
Report & Retention of data/report.

References
1. Principal and practice of Pharmaceutical Medicine edited by Andrew j Fleteher. Lionel D
Edwards, Anthony W Fox. Peter Stonier Published by John Wiley & sons Ltd.
2. Clinical Pharmacotherapeutics- edited by Kamalesh Kholi. Elsevier Publication.
3. Statistical Methods for Clinical Trials, by Mark X Norleans, Marcel and Dekker, Inc, New
York, 2001.

OPEN ELECTIVE (SPECTRAL ANALYSIS)

Teaching Scheme: Examination Scheme:
Theory: 3 Hrs. per week Uni. Exam: 80 marks
Tutorial: 1 Hr. per week Term Work: 20 Marks

Unit-1.Ultra violet and visible spectroscopy: Energy levels and selection rules, Woodward-
Fieser and Fieser-Kuhn rules; Influence of substituent, ring size and strain on spectral
characteristics; Solvent effect; Stereochemical effect; Non-conjugated interactions.
Spectral correlation with structure. Spectral interpretations with drug examples.
Unit-2.Infrared spectroscopy (IR): Characteristic regions of the spectrum. Influence of
substituents, ring size, hydrogen bonding, vibrational coupling and field effect on
frequency. Determination of stereochemistry. Spectral interpretations with drug
examples.
Unit-3.Nuclear magnetic resonance spectrometry (NMR): Magnetic nuclei, chemical shift and
shielding, relaxation processes, chemical and magnetic non-equivalence, local
diamagnetic shielding and magnetic anisotropy, spin-spin splitting, Pascal’s triangle,
coupling constant, mechanism of coupling, quadrupole broadening and decoupling, effect
of conformations and stereochemistry on the spectrum, diastereomeric protons, virtual
coupling, long range coupling-epi, peri, bay effects. Shift reagents-mechanism of action,
spin decoupling and double resonance. Spectral interpretations with drug examples.
Unit-4.Mass Spectrometry (MS): Molecular ion and metastable peak, fragmentation patterns,
nitrogen and ring rules, McLafferty rearrangement, electron and chemical ionization
modes, applications. Spectral interpretations with drug examples.

References:
1. Skoog : Principles of Instrumental Analysis (Saunders College Publishing Philadelphia)
2. M.Orchin and H.H-Jaffe - Theory and applications of ultra violet spectroscopy (John Wiley
Md Sons, N.Y.)
3. Silverstein. Basseler, Moiril – Spectrometric identification of organic compounds (John
Wiley and Sons, N.Y.)
4. Willard, Merritt, Dean - Instrumental Methods of Analysis (CBS Publishers and Distributors,
Delhi)
5. J. R. Dyer - Applications of Absorption Spectroscopy of Organic compounds (Prentice Hall,
London)
6. CN. R. Rao - Chemical applications of IR spectroscopy (Academic press, N.Y.)
7. Higuchi : Instrumental Methods of Analysis (CBS Publishers)
8. Analytical Chemistry by open learning series
9. R. J. Hamilton - Introduction to High Performance Liquid chromatography, (Chapman and
Hall, London)
10. Ewing - Instrumental Methods of Chemical Analysis (McGraw Hill Book Co. New York).
11. Modern methods of pharmaceutical analysis, Roger E. Schirmer.

OPEN ELECTIVE (DRUG REGULATORY AFFAIRS)

Teaching Scheme: Examination Scheme:
Theory: 3 Hrs. per week Uni. Exam: 80 marks
Tutorial: 1 Hr. per week Term Work: 20 Marks

Unit-1.Concept and historical development of pharmaceutical product registration. Effect of

GATT and WTO on commerce of pharmaceuticals. Introduction to IPR, Schedules,
NDA, ANDA.
Unit-2.Globalization of drug industries, Export – import policy of drug, WHO certification,
Batch Processing / Sample Analysis – Documentation & SOPs, 21 CFR Part 11
Compliance. Indian, American and European patent acts.
Unit-3.Introduction to Bioethics, Ethical issues in Clinical studies, ICMR ethical guidelines for
biomedical research, Institutional Ethics committee – composition, role & responsibility,
IRB, SOPs – Ethics committee.
Unit-4.Schedule Y with appendices, CDSCO, ICMR guidelines, Other Indian Regulatory
Authorities: DCGI/DBT/BARC. Introduction, Historical perspective (Nuremberg,
Tuskegee, Belmont, Helsinki), ICH, ICH – GCP and its difference with Indian GCP.
Requirements for BA / BE studies.

References:
1. Guidance for preparing documents that meets Regulatory Requirements by Janet Gough.
2. FDA Regulatory Affairs by Donglas J Pisano & David Mantus.
3. FDA Guidelines.
4. ICH Guidelines.
5. ICMR ethical guidelines
6. Drugs & Cosmetics Act
7. Handbook for GCP: 2005.
8. http://www.who.int/medicines/
9. Good Laboratory Practice Regulations by Weinberg, Marcel Dekker Inc., NY.
10. Good Laboratory Practice by Sharma P.P., Vandana Publishing, New Delhi.

OPEN ELECTIVE (QUALITY ASSURANCE & QUALITY CONTROL)

Teaching Scheme: Examination Scheme:
Theory: 3 Hrs. per week Uni. Exam: 80 marks
Tutorial: 1 Hr. per week Term Work: 20 Marks

Unit-1.Basic concept of Quality Control & Quality Assurance, Total Quality

Management,Philosophy of GMP, cGMP, GLP, ISO, Introduction to ICH guidelines. In
Process quality controls on various dosage forms-sterile and non sterile, SOPs for various
operations. Quality Assurance guidelines for human blood products and large volume
parenterals.
Unit-2.Quality Control Laboratory - Responsibilities and laboratory practices, Routine controls
on instruments, standard test procedure sampling plans. Quality control documentation
and audits of quality control facilities.
Unit-3.Introduction to validation – Equipment validation, Calibration of equipments, Method
validation, Personnel & Process validation, Asceptic validation, Validation of water and
air handling systems.
Unit-4.Regulatory Audits, Regulatory Affairs and compliance – QA in Bioanalytical Laboratory,
Medical diagnostic laboratory and Clinical Departments. Quality assurance in: Queries
and Query resolution, fraud and misconduct, auditing and inspection. Development,
Submission and storage of Quality assurance reports.

References:
1. A Practical guide to Quality management in Clinical Trial research, Graham D. Ogg,CRC
Taylor and Francis.
2. Clinical audit in Phramaceutical Development, Michael R.hamrell, Informa Health Care.
3. Validation and Qualification in Analytical Laboratories, Ludwig Huber, Marcel Dekker
series.
4. Quality Assurance in Pharmaceuticals, OPPI Publication.
5. Pharmaceutical Process Validation by Berry IR and Nash RA (Eds.) Marcel Dekker Inc.,
NY.
6. How to Practice GMPs 2nd Edn. By Sharma P.P., Vandana Publishing, New Delhi.
7. A Guide to Total Quality Management – Kaushik Maitra and Sedhan K. Ghosh

OPEN ELECTIVE (CONTROL PROCESS ANALYTICAL TECHNOLOGY)

Teaching Scheme: Examination Scheme:
Theory: 3 Hrs. per week Uni. Exam: 80 marks
Tutorial: 1 Hr. per week Term Work: 20 Marks

Unit-1.Background of PAT, Goals of PAT, PAT Framework and Process Understanding.

Principles and Tools of PAT.
Unit-2.Quality by Design: History, Defining Product Design Requirements and Critical Quality
Attributes, The Role of Quality Risk Management in QbD, Design Space and Control
Strategy, Quality Systems, Product centric quality by design, Quality by design across the
product lifespan, Quality Systems, Steps involved, Real Time Quality Control. Benefits
of Quality by Design (QbD
Unit-3.Risk Assessment: Introduction , Scope , Principles Of Quality Risk Management, General
Quality Risk Management Process , Risk Management Methodology, Integration of
Quality Risk Management into Industry And Regulatory Operations, Definitions, Risk
Management Methods And Tools, Potential Applications for Quality Risk Management.
Trend Analysis.
Unit-4.Impact of PAT on industry organization & process and regulatory aspects of PAT:
Potential benefits PAT to industry, Draft PAT Guidance September 2003, Final PAT
Guidance September 2004, PAT Team Certification September 2004, PAT Guidance,
PAT Team, ASTM Standards, and support infrastructure Guidance on CFR Part 11
,Compliance Policy Guide 7132c.08, Draft Guidance on “Comparability Protocol”, Draft
Guidance on “Quality Systems Approach to Pharmaceutical CGMP Regulations-Sept
2004, ICH Q8, Q9, and proposed Q10.
References:
1. Guidance for Industry: PAT —A Framework for Innovative Pharmaceutical
Development, Manufacturing, and Quality Assurance, September 2004
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid
ances/ucm070305.pdf
2. Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good
Manufacturing Practice Regulations, September 2006
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid
ances/ucm070337.pdf
3. Guidance for Industry: Q9 Quality Risk Management, June
2006http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm073511.pdf
4. Guidance for Industry: Q8(R2) Pharmaceutical Development Revision 2, November
2009http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm073507.pdf
5. Guidance for Industry: Q10 Pharmaceutical Quality System, April
2009http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm073517.pdf
6. Guidance for Industry: Process Validation: General Principles and Practices, January
2011http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM070336.pdf
7. Eriksson, L., Johansson, E., Kettaneh-Wold, N. and Wold, S., "Multi- and Megavariate
Data Analysis, Principles and Applications." 1st Edition, Umetrics Academy, June 07,
2001, ch 3-4.
8. http://www.fda.gov/cder/OPS/PAT.htm
9. Food and Drug Administration. PAT - A Framework for Innovative, Manufacturing and
Quality Assurance, Draft Guidance. Rockville, MD: 2003.
10. Brown, S., presented at InCINC'94 "Has the 'Chemometrics Revolution' ended? Some
views on the past, present and future of chemometrics." Department of Chemistry and
Biochemistry, University of Delaware 3. Wold, S., presented at InCINC'94
Chemometrics; what do we mean with it, and what do we want from it?" Institute of
Chemistry, Umea University, Umea, Sweden.
11. Kirsch, J., Drennen, J., "Determination of film coated tablet parameters by near infrared
spectroscopy." Journal of Pharmaceutical and Biomedical Analysis, 13, 1273-1281, 1995

OPEN ELECTIVE (INDUSTRIAL PHARMACOGNOSY)

Teaching Scheme: Examination Scheme:
Theory: 3 Hrs. per week Uni. Exam: 80 marks
Tutorial: 1 Hr. per week Term Work: 20 Marks

Unit-1.Cultivation of commercially important plant drugs, factors affecting quality of plant and
animal drugs like Ashwagandha,Glycerrhiza, Dioscorea, Belladonna, Hyoscyamus,
Cinchona, Opium, Digitalis, Senna, Plantago, Mentha, Rauwolfia, medicinal
yams,Guggul,Gymnema,Insulin.
Unit-2.WHO guidelines on good agricultural and collection practices (GACP) for medicinal
plants. Problems and recent trends in pest management, scope of biological control and
use of environment friendly pesticides especially plant derived products, Pyrethroids,
pheromones and juvenile hormones.
Unit-3.Technology for Commercial Utilization of following aromatic plants and derived
products-Lemon grass, Geranium, Basil, Vetier, Patchouli, Celery and Davana ,Valerian.
Unit-4.Herbal cosmetics and their preparation for skin, hair and dental care. Determination of
shelf life of raw drugs, powered drugs, extracts, fractions and finished products.

References
1. Atal, C.K., Kapur, B.M., Cultivation and Utilization of Medicinal and Aromatic Plants,
R.R.L. Jammu.
2. Farooqui, A.A., Sreeramu, B.S., Cultivation of Medicinal and Aromatic Plants University
press, 2001.
st
3. Yoganasimhan, S.N., Medicinal Plants of India, 1 Edition, Interlive Publishing Pvt. Ltd.
4. Medicinal and Aromatic Plant abstracts (MAPA) CSIR, New Delhi.
5. Evans, W.C., Trease and Evans Pharmacognosy, W.B. Saunder & co., London.
6. Wallis, T.E., Text Book of Pharmacognosy.
7. Indian Herbal Pharmacopoeia.
8. Kalia, A.N., Textbook of Industrial Pharmacognosy.
9. Mohammad Ali, Pharmacognosy and Phytochemistry.
10. Bruneton Jean, Pharmacognosy and Phytochemistry of Medicinal Plants.
11. Kaufmann, Natural Products from Plants, CRC Press, New York.
12. Butler, M., Poucher’s Perfumes, Cosmetics and Soaps.
13. Panda, Herbal Soaps and Detergents.
14. Vimladevi, Text Book of Cosmetics.
15. D’Amelio, Botanicals, A Phytocosmetic Desk reference.