ch. bansi lal university, bhiwani - cblu.edu.in€¦ · ch. bansi lal university, bhiwani. session:...

Session: 2016-17

1

Schemes of Examinations

&

Syllabi

of

M. Pharmacy

for

Pharmacology

(2016-2017)

Ch. Bansi Lal University, Bhiwani

Session: 2016-17

2

Ch. Bansi Lal University, Bhiwani

Scheme of Examination for M. Pharmacy -Pharmacology

Semester-I Credits: 34 Marks: 750

Paper

Code

Subjects

Type

of

Course

Contact Hours Per Week Credits Examination Scheme Total

Theory Practical Total Theory Practical Total Internal

Assessment

Theory Practical

MPP-101 Modern Analytical

Techniques-I (MAT-I)

C.M.C 04 -- 04 04 -- 04 20 80 100

MPP-102 Pharmacology and

Therapeutics

C.C 04 -- 04 04 -- 04 20 80 100

MPP-103 Pharmacological

Techniques

C.C 04 -- 04 04 -- 04 20 80 100

MPP-104 Drug Discovery and

Toxicology

C.C 04 -- 04 04 -- 04 20 80 100

MPP-105 Biostatistics I.D.C 04 -- 04 04 -- 04 20 80 100

MPP-106 Practical (MAT-I) C.M.C - 06 (6X1) 06 -- 03 03 -- - 100 100

MPP-107 Practical Pharmacology

(MPP-102-104)

C.C - 18 (6X3) 18 -- 09 09 -- - 100 100

MPP-108 Seminar/ Journal Club C.C 03 -- 03 -- -- 01 -- -- -- 25

MPP-109 Self-study Paper C.C -- -- -- -- -- 01 -- -- -- 25

Total 23 24 47 20 12 34 100 400 200 750

Session: 2016-17

3

Scheme of Examination for M. Pharmacy -Pharmacology

Semester-II Credits: 34 Marks: 750

Paper

Code

Subjects

Type

of

Course

Contact Hours Per Week Credits Examination Scheme Total

Theory Practical Total Theory Practical Total Internal

Assessment

Theory Practical

MPP-201 Modern Analytical

Techniques-II (MAT-II) C.C 04 -- 04 04 -- 04 20 80 100

MPP-202 Clinical Pharmacology C.C 04 --- 04 04 04 20 80 100 MPP-203 Drug Designing and

Pharmacogenomics C.C 04 -- 04 04 -- 04 20 80 100

MPP-204 Molecular Pharmacology C.C 04 -- 04 04 -- 04 20 80 100 MPP-205 Advances in Pharmacology C.M.C 04 - 04 04 -- 04 20 80 - 100 MPP-206 Practical (MAT-II) C.C 06 (6X1) 06 -- 03 03 -- -- 100 100 MPP-207 Practical Pharmacology

(MPP-202-204) C.C -- 18 (6X3) 18 -- 09 09 -- -- 100 100

MPP-208 Seminar/ Journal

Club/Synopsis C.C 3 - 3 - - 01 - - 25

MPP-209 Self-Study Paper C.C - - - - - 01 - - - 25

Total 23 24 47 20 12 34 100 400 200 750

Session: 2016-17

4

Scheme of Examination for M. Pharmacy -Pharmacology 3

rd Semester Credits: 23 Marks: 225

PART-I (DISSERTATION WORK)

Paper

Code Subject

Contact

Hours

Credits

Examination Marks Max. Marks

Internal External

MPP-301 Pharmaceutical Entrepreneurship 04 04 20 80 100

MPP-302 Midterm Evaluation/Presentation/Viva voce -- -- -- 100 100

MPP-303 Journal Club (One Research Paper Per Student) 02 1 25 - 25

MPP-304 Research Work 36 18 - - -

Total 42 23 45 180 225

4th

Semester Credits: 23 Marks: 250

PART-II (DISSERTATION WORK)

Paper

Code

Subject Contact

Hours

Credits

Examination Marks Max. Marks

Internal External

MPP-401 Intellectual Property Rights 04 04 20 80 100

MPP-402 Journal Club (One Research Paper Per Student) 02 01 25 25

MPP-403 Research Work 36 18

MPP-404 Dissertation Evaluation by External Examiner - - - 100 100

MPP-405 Dissertation / Final Presentation & Viva voce - 50 50

Total 42 23 45 230 275

Duration- 02 years (04 semesters)

Total Marks- 2000

Total Credits- 114

Session: 2016-17

5

M. Pharmacy (Pharmacology)

Semester 1

MPP-101

Modern Analytical Techniques -I (MAT- I)

Maximum Marks: 100

Theory Examination: 80

Internal Assessment: 20

Time: 3 hrs

Note: There shall be nine questions in all. Question no. 1 shall be compulsory,

consisting of eight short answer type questions covering the entire syllabus. Two

questions will be asked from each unit. Student will have to attempt one question from

each unit. Each question shall carry equal marks.

UNIT-I

UV-Visible spectroscopy: Brief review of electromagnetic spectrum, UV-Visual range,

energy-wavelength colour relationships. Interaction of electro - magnetic radiation (UV-Vis)

and matter and its effects, Chromophores and their interaction with EMR, Woodward-Fieser

rule, Absorption spectra of organic compounds and complexes illustrating the phenomenon

and its utilization in qualitative and quantitative studies of drugs, Beer-Lambert‟s law, Shifts

and their interpretation (including solvent effects). Multi component analysis, derivative

spectroscopy.

Spectrofluorimerty: Fluorescence, Phosphorescence, Chemiluminescence-Theory,

instrumentation and applications. (9 Lectures)

UNIT-II

Infra-Red Spectroscopy: Nature of Infra-red radiation, Interaction of IR radiation with

organic molecules and effects on bonds, Molecular or infra-red spectra, Brief outline of

classical IR instrumentation and interpretation of spectra, including sample preparation for

spectroscopy, Qualitative interpretation of IR Spectra, Influence of substituents, ring size,

hydrogen bonding vibrational coupling and field effect on frequency, Quantitative methods,

FT-NIR and applications. Recent advances in IR Spectroscopy.

Raman spectroscopy- Principle, Instrumentation and applications.

Laser Spectroscopy: Introduction, principle, instrumentation and applications. (9 Lectures)

UNIT-III

Chromatographic Techniques: Introduction and classification.

High performance TLC – Principle, adsorbents, retention and separation parameters,

detection methods, quantitative and quantitative HPTLC.

Gas Chromatography: Introduction, Principles, Instrumentation, carrier gas, types of

columns, column selection- liquid stationary phases, column efficiency parameters, the Van

Deemter equation, Resolution, Derivatisation methods, Detectors. A critical comparison of

sensitivity, selectivity and field of applications of these detectors. Applications of GC in

Pharmaceutical sciences. (9 Lectures)

Session: 2016-17

6

Unit-IV

Liquid Chromatography: Instrumentation, columns, packing materials, column selection,

mobile phase selection, efficiency parameters, resolution and optimization of

chromatographic parameters. Detectors in HPLC: Comparison of sensitivity, selectivity and

field of applications of these detectors. Modes of HPLC-Ion pair, Ion-exchange, Size

exclusion, Supercritical, Chiral, Gel-permeation, Flash chromatography. Applications of

liquid chromatography. Ultra Performance Liquid Chromatography.

Emission Spectrometry (Atomic Absorption Spectrometry, Flame Photometry).

(9 Lectures)

Reference books:

1. Principles of Instrumental Analysis, 5th Ed., D.A. Skoog, F.J. Holler and T. A. Nieman.

2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M., Bassler &

Morril 5th Ed., 1991.

3. Instrumental Methods of Analysis, H.H. Willard, L.L Merritt, J.A. Dean, F.A. Settle,

7th Ed.

4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol. -2.

5. Drugs & Pharma, Sciences Series, Marcel Dekker Inc.

6. “Applications of absorption spectroscopy of organic compounds” by John R. Dyer.

7. “Contemporary practice of chromatography” by Poole, Colin F. and Sheila A. Schuette.

8. Ewing‟s Analytical Instrumentation Handbook, edited by Jack Cazes, CRC press.

9. “Practical HPLC method development” by L. R. Snyder Willey Interscience, Second

Ed.

10. Aldrich FT-IR Spectral Library.

11. “Pharmaceutical Analysis” by David C. Lee Blackwell Publisher.

Session: 2016-17

7


Semester 1

MPP-106

Practical (MAT)

Maximum Marks: 100

Time: 06 hrs/week

1. Use of UV Vis spectrophotometer for analysis of Pharmacopoeial compounds and

their formulations.

2. Simultaneous estimation of multi component containing formulations by UV

spectrophotometry.

3. Effect of pH and solvent on UV spectrum of certain drugs.

4. Experiments on factors affecting the absorbance/fluorescence in UV spectroscopy/

Fluorimetry.

5. Interpretation of IR spectra

6. Experiments based on various chromatography techniques for separation of mixture

of compounds.

7. Any other practical based on aforementioned theory.

Reference books:

1. Principles of Instrumental Analysis, 5th Ed., D.A. Skoog, F.J. Holler and T. A.

Nieman.




7th Ed.

4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol. -2.



7. “Contemporary practice of chromatography” by Poole, Colin F. and Sheila A.

Schuette.



Ed.



Session: 2016-17

8


Semester 1

MPP-102

PHARMACOLOGY AND THERAPEUTICS

Maximum Marks: 100



Time: 3 hrs





UNIT-I

Introduction to Pharmacology:

Pharmacokinetics: The dynamics of drug absorption, distribution and elimination with

special reference to factors affecting drug metabolism.

Pharmacodynamics: (Mechanisms of drug action and the relationship between drug

concentration and effect) Mechanisms of drug actions: Receptors, Structural and functional

families of receptors, Signal transduction through cytoplasmic second messengers, receptor

regulation, Classification of receptors, Methods of receptor characterization. Quantitation of

drug-receptor interactions and elicited effect. Autonomic Nervous System. (9 Lectures)

UNIT-II

Pathophysiology and Drug Therapy of Cardiovascular Disorders

Angina, arrhythmia, congestive heart failure, hyperlipoproteinemias andhypertension.

Drug Therapy of Endocrine Disorders

Disorders of thyroid gland, adrenal gland, diabetes mellitus, gonadal hormones and

contraceptives. (9 Lectures)

UNIT-III

Pathophysiology and Drug Therapy of Neurological and Psychiatric Disorders

Alzhiemer's disease, anxiety, depression, epilepsy, Huntington‟s disease, Parkinson's disease

and schizophrenia.

Pain and Inflammation

Drugs used in the treatment of osteoarthritis, gout and NSAIDs.

Pathophysiology and Drug Therapy of Gastrointestinal Disorders

Peptic ulcers, Helicobacter pylori and inflammatory bowel disease.

Pathophysiology and Drug Therapy of Respiratory Disorders

Asthma, tuberculosis COPD and Cough. (9 lectures)

Session: 2016-17

9

UNIT-IV

Chemotherapy of Microbial and Parasitic Diseases

Sulfonamides, quinolones, chloramphenicol, aminoglycosides, tetracyclines,penicillins,

cephalosporins, antiviral, antifungal, helminthiasis, malaria, leprosy,tuberculosis and

antineoplastic agents. Protozoal and Leishmania.

Multi-drug resistance, mechanism and drug resistant tuberculosis and malaria, antimicrobial

and anticancer. (9 Lectures)

Reading Material Recommended:

1. Brunton L.L., Lazo J.S. and Parker K.L., Eds. Goodman & Gilman‟s The

Pharmacological Basis ofTherapeutics. McGraw-Hill, New York. Latest Edition.

2. Katzung B.G. Basic and Clinical Pharmacology. Lange/McGraw-Hill Medical

Publications, NewYork. Latest Edition.

3. Kalant H. and Roschlan WHE. Principles of Medical Pharmacology. Oxford

University Press,New York. Latest Edition.

4. Rang H.P., Dale M.M. and Ritter J.M. Pharmacology. Churchill Livingstone,

New York. LatestEdition.

5. Sharma H.L. and Sharma K.K. Principles of Pharmacology. Paras Publisher,

Delhi. LatestEdition.

6. Shargel L., Mutnick A.H., Souney P.F. and Swanson L.N. Comprehensive

Pharmacy Review.Wolters Kluwer Health / Lippincott William & Wilkins, New

Delhi. Latest Edition.

7. Dipiro J.T., Talbert R.L., Yee G.C., Matzke G.R., Wells B.G. and Posey L.M.,

Eds.Pharmacotherapy: A Pathophysiologic Approach. McGraw-Hill, New York.

Latest Edition.

8. Gudman & Gillman

Session: 2016-17

10


Semester 1

MPP-103

PHARMACOLOGICAL TECHNIQUES

Maximum Marks: 100



Time: 3 hrs





UNIT-I

Development and Scope of Experimental Pharmacology: CPCSEA guidelines to conduct experiments on animals, Animal house: Design and

facilities to maintain the animals, Common laboratory animals, breeding methods,

anesthesia& euthanasia of experimental animals, different routes of drug administration.

Alternatives to Animal Screening

Cell lines and other in-vitro techniques (ELISA, PCR techniques). (9 Lectures)

UNIT-II

Biological assays

Bioassay, various types of bioassays, advantages and limitations of bioassays with suitable

examples

Immunoassays: General principles and procedures of immunoassays. Immunoassay for

digoxin and insulin

Genetically Modified Animals as Tools of Experimental Pharmacology Transgenic animals and their applications in drug discovery, techniques involved in

transgenic technology and gene knockout, gene knockdown and gene silencing animals.

(9 Lectures)

UNIT-III

Experimental Techniques Employed in the Screening of Drugs Belonging to Following

Categories-I Antipsychotics, antianxiety agents, nootropics, antidepressants, antiparkinsonianagents,

antiepileptics, analgesics and anti-inflammatory agents.

Antidiabetic and antiobesity drugs. (9 Lectures)

UNIT-IV

Experimental Techniques Employed in the Screening of Drugs Belonging to Following

Categories-II Antianginals, antiarrhythmics, antiatherosclerotics, antihypertensive agents and drugs for

myocardial infarction.

Antiulcer, antimalarial and anthelmintic agents.

Hepatoprotectives and renoprotectants.

Evaluation of antioxidant profile (Biochemical estimation). (9 Lecture)

Session: 2016-17

11

Books Recommended:

1. Remington’s Pharmaceutical Sciences 20th edn.

2. Bartfai T. and Lee G.V. Drug Discovery. Elsevier, New York. Latest Edition.

3. Huang Z. Drug Discovery Research. Wiley Inter Science, USA. Latest Edition.

4. Evans R.P., Drug and Biological Development. Springer, USA. Latest Edition.

5. Ricky N.G. Drugs from Discover to Development. Wiley-Blackwell, USA.

Latest Edition.

6. Evaluation of drug activities: Pharmacometrics by D R Laurence and A L

Bacharach Vol1 and 2 Academic Press, London, U.K., 1964.

7. Drug Discovery and Evaluation Pharmacological Assay by Vogel H G and

Vogel W H (Springer publication)

8. Kulkarni S.K. Handbook of Experimental Pharmacology. Vallabh Prakashan,

New Delhi. Latest Edition.

9. Modern drug research- Paths to better and safe drugs (Medicinal Chemistry vol

9) by Y C Martin, E. Kutter and V. Austel

10. Modern Methods of Drug Discovery by Hillisch, A and Hilgenfeld, R

11. David R. Gross, Animal Models in Cardiovascular Research, 2nd

edition,

Kluwer Academic Publishers, London, U.K., 1994.

Session: 2016-17

12


Semester 1

MPP-104

DRUG DISCOVERY AND TOXICOLOGY

Maximum Marks: 100



Time: 3 hrs





UNIT-I

Introduction to Drug Discovery: History of drug discovery, sources of drugs (plants, animals, microorganisms, drugs from

organic synthesis), existing drugs as a source of new drug, lead identification and

optimization.

Preclinical Studies and Drug Development

Stages of drug discovery, phase zero, pre-clinical and safety evaluation, acute, sub-acute,

chronicstudies, in-vivo and in-vitro studies (behavioral, biochemical, neurochemical

models)and special studies including carcinogenicity, mutagenicity, teratogenicity.

(9 Lectures)

UNIT-II

Novel Drug Targets for Drug Discovery: Exploration and investigation of therapeutic drug targets as enzymes, receptors, genes,

platelets and matrix metalloproteases for drug design. (9 Lectures)

UNIT-III

Toxicology:

Concept, development and scope of toxicology, behavioural and neurotoxicity, teratology,

endotoxin, pesticides, cardiac, hepatic, renal and pulmonary toxicity. Industrial,

environmental and forensic toxicology, clinical toxicology, principles andmanagement of

different types of poisoning, toxicity reactions, Reproductive toxicology assessment,

relationship between maternal and developmental toxicity, target organ toxicity like kidney,

liver, cardiac and endocrine toxicity, OECD guidelines, Principle of GLP. (9 Lectures)

UNIT-IV

Immunotherapy: Introduction to immune system, cellular and humoral immunity,

complement, antigen-antibody interactions, immunity to bacteria, virus, protozoa, and fungi,

immunomodulators and immunosuppressants and their use in autoimmune disorders,

principles and development of vaccines against different diseases. (9 Lectures)

Session: 2016-17

13

Books Recommended:

1. Bartfai T and Lee GV. Drug Discovery. Elsevier, New York. Latest Edition.


3. Evans RP, Drug and Biological Development. Springer, USA. Latest Edition.

4. Ricky NG. Drugs from Discover to Development. Wiley-Blackwell, USA.

5. Ballantyne B, Marrs T and Turner P. General and Applied Toxicology. Macmillan

Press Ltd., London. Latest Edition.

6. Practical approaches in toxicity studies by Poole and Leslie

7. Alternatives to animals in toxicity testing. Scientific American 26: (1989), 16-22.

8. Goldsby RA, Kindt TJ and Osborne BA. Kuby‟s Immunology. WH Freeman Book,

New York. Latest Edition.

9. Klaasen KCD and Amdur MA. Casarett&Doul's Toxicology. Mcmillan Press Ltd.,

London. Latest Edition.

10. Kulkarni S.K. Handbook of Experimental Pharmacology. Vallabh Prakashan, New


Session: 2016-17

14


Semester 1

MPP-105

BIOSTATISTICS

Maximum Marks: 100



Time: 3 hrs





Unit I

Probability and Descriptive Statistics Scientific notation: significant digits, rounding off,

scientific notation, Error analysis; Counting and Probability: Addition rules; Permutations;

Combinations; Inclusion-exclusion rule; Sampling with and without replacement;

Conditional probability: Bayes‟ theorem; Independence; Descriptive statistics and Random

variables; Measures of central tendency: mean, median, mode; Expectation; Measures of

spread: range, percentile, standard deviation; Higher moments: kurtosis, skew, Displaying

data: Histograms, stemand-leaf plots, box plots, frequency distributions; Discrete random

variables: Bernoulli, Binomial, Poisson; Geometric distributions; Continuous random

variables: Normal; Exponential distributions; Standard normal distribution. (9 Lectures)

Unit II

Inferential statistics and one sample hypothesis testing Samples and populations: Random,

stratified and cluster sampling; Single- and Double-blind experiments; Point and interval

estimates; Sampling distributions: t, chi-square, F distributions; Hypothesis testing: null and

alternative hypotheses, decision criteria, critical values, type I and type II errors, Meaning of

statistical significance; Power of a test; One sample hypothesis testing: Normally distributed

data: z, t and chi-square tests; Binomial proportion testing. (9 Lectures)

Unit III

Multi-sample and nonparametric hypothesis testing two sample hypothesis testing;

Nonparametric methods: signed rank test, rank sum test; Kruskal-Wallis test; Analysis of

variance:One-way ANOVA (9 Lectures)

Unit IV

Curve fitting Regression and correlation: simple linear regression; Least squares method;

Analysis of enzyme kinetic data; Michaelis-Menten; Lineweaver-Burk and the direct linear

plot; Logistic Regression; Polynomial curve fitting.

Design of Experiments Single factor experiments; Randomized block design; Lackett-

Burman Design; Comparison of k treatment means; Factorial designs; Blocking and

confounding; Response surface methodology. (9 Lectures)

Session: 2016-17

15

Texts/References

1. Bernard Rosner, Fundamentals of Biostatistics, 5th Edition, Thomson Brooks/Cole,

2000.

2. Richard A. Johnson, Probability and Statistics for Engineers, 6th Edition, Prentice

Hall, 2000.

3. Morris H. DeGroot, Mark J. Schervish, Probability and Statistics, 3rd Rev. Edition,

Addison-Wesley, 2002.

4. E. Kreyszig, Advanced Engineering Mathematics, 9th Edition, John Wiley, 2006.

Session: 2016-17

16


Semester 1

MPP-107

PRACTICAL PHARMACOLOGY

Maximum Marks: 100

Time: 18 hrs

1. Principles of Experimental Pharmacology:

a) Experimental animals in pharmacological research

b) Care, use and housing of experimental animals, CPCSEA guidelines

c) Standard techniques used in experimental animals

d) Euthanasia, anaesthetics and analgesics used in experimental animals

2. Qualitative study of agonists and antagonists on isolated muscle preparations like

fundus strip, uterus, tracheal chain, vas deferens, anococcygeus muscle, ileal

preparations

3. ED50, pA2, pD2, value determinations of agonists and antagonists on isolated muscle

preparations like fundus strip, uterus, tracheal chain, vas deferens, anococcygeus

muscle, ileal preparations

4. Bio-assays of Autonomic drugs and Autacoids and other practicals pertaining to the

theory syllabus.

5. Bioassay of Ach by interpolation, matching and bracketing methods

6. Bioassay of Ach by 3-point and 4-point methods.

7. Bioassay of histamine by 4-point or 3-point methods.

8. Bioassay of oxytocin by 3- or 4-point methods.

9. Bioassay of d-tubocurarine by cumulative method.

10. Bioassay of 5-HT by 3- or 4- point methods.

11. To study the myelosuppressive effects of anticancer agent

12. To study the effect of prokinetic agents on gastric emptying

13. Immunoassays through Elisa.

Preclinical Screening:

1. General techniques involved in experimental Pharmacology.

Screening of drugs, with appropriate statistical tests, for the following activities:

2. Analgesic by hot plate, tail flick, tail dip and writhing methods.

3. Anti-inflammatory drugs by rat paw edema method and cotton pallet granuloma

4. Antipyretics by yeast induced pyrexia in rats.

5. Antiepileptic drugs by MES & PTZ models.

6. Local anaesthetics drugs by infiltration, nerve plexus and surface anaesthesia methods.

7. To study the effect of hepatic microsomal enzyme induction and inhibition by recording

the duration of pentobarbital sleeping time

8. To study the apomorphine-induced compulsive behaviour (stereotype) in mice.

9. To study the antianxiety effect of drugs in mice using elevated plus-maze apparatus, Y

maze, Audiogenic chamber and Hebb‟s rectangular maze

10. To study the phenothiazine-induced catatonia in rats.

11. To study the anti-secretory and ulcer-protective effect of drugs in pylorus ligated rats.

12. Myelosuppressive activity of a drug through determination of hematological parameters

in rats.

Session: 2016-17

17

Toxicity studies:

1. Problem solving exercises on acute toxicity test to find out LD50 of a drug.

2. Brine-shrimp lethality bioassays

3. Drug Mutagenicity study using Mice bone-marrow chromosomal aberration test

4. Drug Mutagenicity study using Mice bone-marrow micronucleus test.

5. Histopathology of organs.

Books Recommended:

1. Remington’s Pharmaceutical Sciences 20th edn.

2. Bartfai T. and Lee G.V. Drug Discovery. Elsevier, New York. Latest Edition.


4. Evans R.P., Drug and Biological Development. Springer, USA. Latest Edition.

5. Ricky N.G. Drugs from Discover to Development. Wiley-Blackwell, USA. Latest

Edition.

6. Evaluation of drug activities: Pharmacometrics by D R Laurence and A L Bacharach

Vol1 and 2 Academic Press, London, U.K., 1964.

7. Drug Discovery and Evaluation Pharmacological Assay by Vogel H G and Vogel W

H (Springer publication)



9. Modern drug research- Paths to better and safe drugs (Medicinal Chemistry vol 9) by

Y C Martin, E. Kutter and V. Austel

10. Modern Methods of Drug Discovery by Hillisch, A and Hilgenfeld, R

11. David R. Gross, Animal Models in Cardiovascular Research, 2nd

edition, Kluwer

Academic Publishers, London, U.K., 1994.

Session: 2016-17

18


Semester 2

MPP-201

Modern Analytical Techniques-II (MAT-II)

Maximum Marks: 100



Time: 3 hrs





UNIT-I

Nuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR (Magnetic

Properties of nuclei, applied field and precession, absorption and transition frequency).

Chemical shift concept, Isotopic nuclei, Reference standards, proton magnetic spectra, their

characteristics, presentation, terms used in describing spectra and their interpretation (signal

no., position, intensity), Brief outline of instrumental arrangements and some practical

details, Signal multiplicity phenomena in high resolution PMR, Spin-spin coupling,

Application of Signal Splitting and coupling constant data to interpretation of spectra,

Decoupling and shift reagent methods. Quantitative NMR. Brief outline of principles of 13C

NMR. Introduction to 2-D NMR Techniques. Applications of NMR technique in

Pharmaceutical sciences. (9 Lectures)

UNIT-II

Mass Spectrometry: Basic principles and brief outline of instrumentation. Ion formation

and types, molecularion, meta stable ions, fragmentation processes, Fragmentation patterns

and fragment characteristics in relation to parent structure and functional groups, Relative

abundances of isotopes and their contribution to characteristic peaks, Mass spectrum, its

characteristics, presentation and interpretation, Chemical ionisation mass spectrometry, ESI,

Ion-trap,. FAB mass spectroscopy. Applications of mass spectrometry. (9 Lectures)

Unit-III

X-Ray Diffraction Methods: Elementary crystallography, X-Ray diffraction, Bragg‟s law,

X-Ray powder diffraction, X-Ray powder diffractometer- interpretation of data.

Thermal Analysis: Principles and applications of thermogravimetric analysis (TGA),

Differential thermal analysis (DTA) and Differential scanning Calorimetry (DSC).

(9 Lectures)

Unit-IV

Electrophoresis: Principle, techniques, instrumentation including detection strategies and

applications

Hyphenated techniques: Brief introduction (LC-MS, GC-MS, GC-IR, LC-NMR and GC-

NMR) and applications.

Radioimmunoassay Assay and ELISA: Principle, instrumentation and applications.(9

Lectures)

Session: 2016-17

19

Reference books:


Nieman.

2. "Spectrometric Identification of Organic Compounds" Silverstein, R.M.,

Bassler&Morril 5th Ed., 1991.


7th Ed.

4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol -2.

5. Drugs &Pharma, Sciences Series, Marcel Dekker Inc.


7. “Contemporary practice of chromatography” by Poole, Colin F. and Sheila A. Schuette.



Ed.



Session: 2016-17

20


Semester 2

MPP-206

Practical (MAT-II)

Maximum Marks: 100

Time: 06 hrs/week

1. Interpretation of NMR and Mass spectra.

2. Experiments Based on flame photometry.

3. Any other practical based on aforementioned theory.

Reference books:


Nieman.




7th Ed.

4. Pharma Analysis, Modern Methods - (Ed) James W Munson Part-B, Vol -2.



7. “Contemporary practice of chromatography” by Poole, Colin F. and Sheila A.

Schuette.



Ed.



Session: 2016-17

21


Semester2

MPP-202

CLINICAL PHARMACOLOGY

Maximum Marks: 100



Time: 3 hrs





UNIT-I

Principles and advancements in the following topics:

Introduction to Clinical Pharmacology

Definition, scope and development of clinical pharmacology, role of pharmacist in

healthcare system, prescription monitoring and national drug policy,

pharmacoepidemiology, pharmacovigilance, patient counselling, medication errors and drug

information systems, BA/BE studies.

Concepts of Pharmaceutical Care and its Implementation

Plan, components and challenges, communication and behavioural skills in clinical

pharmacology practice. (9 Lectures)

UNIT-II

Drug Therapy in Specialized Patient Populations

Neonates: Special childhood diseases and their management, national immunization

programmes, relevant paediatric management issues as dosages adjustment,

pharmacokinetics and compliance.

Geriatrics: Pharmaceutical care plan based on age related physiological and

pharmacokinetic/pharmacodynamic changes, compliance related issues.

Pregnancy and Lactation: Guidelines and principles of drug therapy during pregnancy and

lactation. Management of hypertension, diabetes, epilepsy etc. during pregnancy. (9 Lecture)

UNIT-III

Clinical Trials:

a) GCP, ICH & ICMR guidelines to conduct clinical trials

b) Requirements of clinical trials, Helsinki declaration, ethical and legal issues

inclinical trials.

c) Design (placebo, multicentre clinical trials, randomization, blinding) and different

phases of clinical trials (Phase 1 to 4), principles of controlled clinical trials.

d) Protocol designing, CRF, patient informed consent, patient enrolment, inclusion and

exclusion criteria, withdrawals and drop out, run-in period.

e) Clinical trial team, monitoring of clinical trial, report preparation, deviations

inclinical trials.

f) Clinical data management and publishing research studies.

g) Orphan drugs

Session: 2016-17

22

h) Institutional Ethics Committee (IEC), DSMB/IRB

i) Compensation in clinical trial (9 Lectures)

UNIT-IV

Adverse Drug Reactions

Incidence, importance, surveillance and their monitoring, WHO ADR reporting programmes

in India and drug interactions.

Pharmacoeconomics: Cost and outcomes research and its potential applications in health

and medicine, types of cost like marginal cost, average costs, medical and nonmedical costs,

direct and indirect costs. Pharmacoeconomic studies: Costminimization, cost-benefit, cost-

effectiveness and Cost-utility analysis.

Telemedicine History and advances in telemedicine, benefits and limitations of telemedicine. (9 Lectures)

Books Recommended:

1. Dhillon S., Kostrzewski, A., Clinical Pharmacokinetics, Pharmaceutical Press,

London.

2. Dipiro, J., Spruill, W., Wade, W., Blouin, R., Pruemer, J., Concepts in clinical

pharmacokinetics, American society of health-system pharmacists, Inc.

3. Burton, M., Shaw, L., Schentag, J., Evans, W., Applied pharmacokinetics &

pharmacodynamics, Lippincott Williams & Wilkins, Philadelphia

4. Kimki C., Hui, Duffull B., Stephen, Simulation for the designing clinical trials by

Marcel Dekker Inc., New York.

5. Tom Walley, Alan Haycox and Angela Boland, Pharmacoeconomics, Elsevier.

6. Bootman JL, Townsend RJ, McGhan WF, Principles of Pharmacoeconomics, Harvey

Whitney Books Company, Cincinnati, OH

7. Bryan Ballantyne, Timothy Marrs, Paul Turner. General and Applied Toxicology by

Stockton press.

8. Methods of clinical trials by Alan Spreit and Simon.

9. Clinical Pharmacology by P N Bennet and Brown

10. The Oxford textbook of Clinical Pharmacology and drug therapy by D.G. Graham-

Smith and J.K.Aronson.

Session: 2016-17

23


Semester 2

MPP-203

DRUG DESIGNING AND PHARMACOGENOMICS Maximum Marks: 100



Time: 3 hrs

NOTE: In all nine questions will be set, two from each unit and one compulsory

question of short answer type covering all the units. Students are required to attempt

one compulsory question and four other questions selecting at least one from each unit.

All questions are of equal marks.

Theory

UNIT I

In-Silico Tools/Software, general ideas of drug designing, 2D and 3D QASR, concept of a

pharmacophore and pharmacophore based searches of ligand databases. Concepts of

COMFA. Methods for simulated docking (9 Lectures)

UNIT II

Drug response to patients, Structural influence in the Drug response. Efficacy and

metabolism of drugs. Drug metabolism pathways and adverse drug reactions. Detoxification

and poisoning and Drug discovery and approval. Metabolic changes of drugsand related

organic compounds - Ayurgenomics - Genomics and Modern Medicine. Pharmacogenomics

and Pharmacognosy. (9 Lectures)

UNIT III

Concepts of Pharmacogenetics, Pharmacogenomics- Introduction, basic concepts

aboutgenetic diseases.Personalized medicine- introduction and importance. The genetics

oftherapeutic targets and gene-based targets. Pharmacogenomics necessity in drugdesigning.

Polymorphisms-Introduction, types and importance in Drug targets.Prediction ofstructural

changes among sequences by the influence of polymorphisms. Genetic analysisof human

variation, Microsatellite for studying genetic variation. (9 Lectures)

UNIT IV Tools for pharmacogenomics analysis. Pharmacokinetics (PK), Pharmacodynamics (PD).

Process in Structural Pharmacogenomics- Target Structure optimization, Validation, lead

identification, ADME prediction, synthesis, assays and Clinical trials. (9 Lectures)

SUGGESTED READINGS:

1. Rapley R and Harbron S. Molecular analysis and Genome discovery.John Willey &

Sons, Ltd. 2004.

2. Falconer DS, Mackay TFC, Introduction to Quantitative Genetics.4th Edition.

3. Daniel A. Brazeau, PhD, and Gayle A. Brazeau.A Required Course in Human

Genomics, Pharmacogenomics and Bioinformatics.

4. Rosenberg NA, Pritchard JK, Weber JL, Cann HM, Kidd KK, Zhivotovsky LA,

Feldman MW Science, Vol 298 (5602), 2381-2385, 2002.

Session: 2016-17

24

5. Anderson JL, Horne BD, Stevens SL, et al. for the Couma-Gen

Investigators.Randomized Trial of Genotype-Guided Versus Standard Warfarin Dosing

in PatientsInitiating Oral Anticoagulation.Circulation.2007,116, 2563

Session: 2016-17

25


Semester 2

MPP-204

MOLECULAR PHARMACOLOGY

Maximum Marks: 100



Time: 3 hrs





UNIT-I

Molecular Biology DNA and genome, basic double helix structure, flow of genetic information, molecular basis

of transcription and protein synthesis.

Receptor Interactions

Role of cyclic nucleotides, phosphoinositides, arachidonic acid, calcium and nitric oxide in

cellular signalling.Pharmacology of toll-like receptors. (9 Lectures)

UNIT-II

Recombinant DNA Technology Tools of recombinant DNA, restriction endonucleases, other enzymes, plasmid,

bacteriophage, cosmid, vectors, c-DNA, genomic library, gene isolation, cloning,

expression, DNA sequencing, oligonucleotide synthesis, southern and northern

hybridization, fluorescence in-situ hybridization, restriction fragment length polymorphism,

PCR, DNA fingerprinting and their applications for diagnosis of disease, site-directed

mutagenesis and gene silencing, Vaccines. (9 Lectures)

UNIT-III

Principles of Gene Therapy

Gene transfer technologies, clinical applications of gene therapy, different targets of gene

therapy, gene-based personalized drug therapy, antisensetechnology.

Stem Cell Introduction to stem cells- Embryonic Stem Cells, Adult stem cells, Molecular basis

pluripotentency and its application, Stem cell niches, Stem cell renewal, Cell cycles

regulators in stem cells. Epigenetic mechanism of cellular memory, Germ line stem cells,

Stem cells and cloning, nuclear cloning and Epigenetic reprogramming; Growth Factors and

Signal Cascades BMP, Nodal, Wnt, Notch and Retenoid signalling during

gastrulation.Biology and its implications in modern medicine. (9 Lectures)

Session: 2016-17

26

UNIT-IV

Pharmacology of endothelins, nitric oxide, purines, peptides and cytokines, their agonists

and antagonists. Pharmacogenetics, Biotechnology derived products and their regulatory

requirements

Functional Genomics and Proteomics: Analysis of microarray data; Protein and peptide

microarray based technology; PCR-directed protein in situ arrays; structural proteomics

(9 Lectures)


1. Lodish H., Baltimore D., Berk A., Zipursky SL., Matsundaira P. and Darnell J.

Molecular CellBiology. W.H. Freeman & Company, New York. Latest Edition.

2. Brown T.A. Gene cloning and DNA analysis. Blackwell Science, USA. Latest

Edition.

3. Alberts B., Bray D., Lewis J., Raff M. Roberts K. and Watsaon J.D., Eds. Molecular

Biology of theCell. Garland Publishers, New York. Latest Edition.

4. Muller R.F. and Youngh ID., Eds. Emmery's Elements of Medical Genetics.

ChurchillLivingstone, New York. Latest Edition.

Session: 2016-17

27


Semester 2

MPP-205

ADVANCES IN PHARMACOLOGY

Maximum Marks: 100



Time: 3 hrs





UNIT-I

Receptor Pharmacology

Classification and structure of receptors: Dopamine receptors, serotonin receptors,

endothelin receptors, GABA-benzodiazepine receptors, excitatory amino acid receptors,

sigma receptors, adenosine and cannabinoids, PCR and G-Protein Receptor.

Cytokines Classification, cytokines receptors, chemokine receptors and their role in CNS

and CVS disorders.

NanomedicinePrinciple, applications, nanodevices and nanoparticles in medicine.

(9 Lectures)

UNIT-II

Neurotrophins Nerve growth factor, brain derived neurotrophic factor, neurotrophin 3 & 4,neurotrophin

receptors and their involvement in depression and neurodegenerativedisorders.

Neurotransporters Plasma membrane neurotransmitter transporters (Na+/Cl- dependent

neurotransmitter transporters, Na+/K+ dependent glutamate transporters), vesicular

neurotransmitter transporters (monoamine transporters and acetylcholine transporters.

Apoptosis Necrosis, apotototic cell death cascade, implications in inflammation and

asthma,beta cell apoptosis in diabetes. (9 Lectures)

UNIT-III

ProbioticsPre and probiotics, mechanism of action, therapeutic applications, ethical issues

&safety considerations.

Therapeutic potential of purinergicsignaling and xanthine oxidase inhibitors in

diversepathological conditions.

Mitochondrial dysfunction linked neurological diseases, mitochondrial mediated celldeath in

diabetes. (9 Lectures)

UNIT-IV

Newer antibiotics and chemotherapeutic agents, biochemical mechanisms of multidrug

resistance in chemotherapy, strategies to reverse MDR. Endothelium derived vascular

substances (NO, endothelins) and their modulators,pharmacology of atrial peptides, reactive

oxygen intermediates, antioxidants and theirtherapeutic implications.

Pharmacology of leptin and its receptors, β3 adrenoceptor and antiobesity drugs.

(9 Lectures)

Session: 2016-17

28


1. Annual Reviews of Pharmacology and Toxicology.

2. Pharmacological Reviews.

3. Trends in Pharmacological Sciences.

4. Trends in Neurosciences.

5. Journal of Pharmacology and Experimental Therapeutics.

Session: 2016-17

29


Semester 2

MPP-207

PRACTICAL PHARMACOLOGY

Maximum Marks: 100

Time: 18hrs

1. Phytochemical investigation of some herbs

a) Extraction and fractionation of some herbs.

b) Preliminary chemical investigation of some extracts

c) Chromatographic evaluation of extracts.

d) Separation and characterisation of selected molecules through

HPLC/HPTLC/GC-MS.

e) Chemical characterisation of some known drug through UV and IR

2. To generate Pharmacokinetic parameters to a drug based on hypothetical

model/methods.

3. Problem solving exercises on calculation of doses (maintenance and loading etc.) in

different cases.

4. Determination of Plasma concentration of drugs using HPLC.

5. Exercises on evidence-based medicine: SOAP to hypothetical/real cases. (Minimum

of 12)

6. Clinical Chemistry through determination of Fasting Blood Sugar, Lipid profile,

Liver function test, urea and Creatine.

7. To biologically identify the poisons/drugs present in the biological fluids/solutions

based on the leads obtain from the case histories

8. Some in vitro enzyme based bioassays (5-LO, AchE inhibition)

9. To demonstrate alpha action of a drug

10. To demonstrate beta action of a drug

11. To demonstrate muscarinic action of a drug

12. To demonstrate nicotinic action of drug

13. To demonstrate 5 HT action of a drug.

14. Antioxidant activity of Super oxide dismutase (SOD), Catalase, Reduced glutathione.

15. To assess competitive antagonism between Ach and d-tubocurarine, through pA2

value on rectus muscle.

16. To assess the influence of Physostigmine and d-tubocurarine on DRC of

acetylcholine.

17. Plasmid DNA Extraction

18. Restriction Enzyme Digestion.

19. Ligation of Digested DNA

20. Transformation of Bacterial Cells

21. Genomic DNA Extraction

22. PCR amplification

23. Polyacrylamide Gel Electrophoresis

24. Western Blotting.

Session: 2016-17

30

Books Recommended:

1. Bartfai T and Lee GV. Drug Discovery. Elsevier, New York. Latest Edition.


3. Evans RP, Drug and Biological Development. Springer, USA. Latest Edition.

4. Ricky NG. Drugs from Discover to Development. Wiley-Blackwell, USA.

5. Ballantyne B, Marrs T and Turner P. General and Applied Toxicology. Macmillan

Press Ltd., London. Latest Edition.

8. Practical approaches in toxicity studies by Poole and Leslie

9. Alternatives to animals in toxicity testing. Scientific American 26: (1989), 16-22.

11. Goldsby RA, Kindt TJ and Osborne BA. Kuby‟s Immunology. WH Freeman Book,

New York. Latest Edition.

12. Klaasen KCD and Amdur MA. Casarett&Doul's Toxicology. Mcmillan Press Ltd.,

London. Latest Edition.



14. Clinical Pharmacy and Therapeutics by Roger Walker and Clive Edward 3rd

edition

15. Davidson‟s Principles and Practice of Medicine 18th

edition

16. Text Book of Therapeutics, Drug and Disease Management by Herfindal E T and

Gourley D R 6th

edition.

17. Avery‟s Drug Treatment.

18. Basic and Clinical Pharmacology by B G Katzung 7th

edition.

19. Annual Reviews of Pharmacology and Toxicology.

20. Pharmacological Reviews.

21. Trends in Pharmacological Sciences.

22. Trends in Neurosciences.

23. Journal of Pharmacology and Experimental Therapeutics.

Session: 2016-17

31


Semester 3

MPP-301

PHARMACEUTICAL ENTREPRENEURSHIP

Maximum Marks: 100



Time: 3 hrs





UNIT-I

Accounting and Finance

Taking decision on starting a venture; Assessment of feasibility of a given venture/new

venture; Approach a bank for a loan; Sources of financial assistance; Making a business

proposal/Plan for seeking loans from financial institution and Banks; Funds from bank for

capital expenditure and for working; Statutory and legal requirements for starting a

company/venture; Budget planning and cash flow management; Basics in accounting

practices: concepts of balance sheet, P&L account, and double entry bookkeeping;

Estimation of income, expenditure, profit, income tax etc.

UNIT-II

Marketing

Assessment of market demand for potential product(s) of interest; Market conditions,

segments; Prediction of market changes; Identifying needs of customers including gaps in

the market, packaging the product; Market linkages, branding issues; Developing

distribution channels; Pricing/Policies/Competition; Promotion/ Advertising; Services

Marketing

UNIT-III

Negotiations/Strategy With financiers, bankers etc.; With government/law enforcement authorities; With

companies/Institutions for technology transfer; Dispute resolution skills; External

environment/changes; Crisis/ Avoiding/Managing; Broader vision–Global thinking

Information Technology How to use IT for business administration; Use of IT in improving business performance;

Available software for better financial management; E-business setup, management.

UNIT-IV

Human Resource Development (HRD) Leadership skills; Managerial skills; Organization structure, pros & cons of different

structures; Team building, teamwork; Appraisal; Rewards in small scale set up.

Fundamentals of Entrepreneurship Support mechanism for entrepreneurship in India

Session: 2016-17

32

Role of knowledge centre and R&D Knowledge centres like universities and research institutions; Role of technology and

upgradation; Assessment of scale of development of Technology; Managing Technology

Transfer; Regulations for transfer of foreign technologies; Technology transfer agencies.

Case Study 1. Candidates should be made to start a „mock paper company‟, systematically

following all the procedures.

• The market analysis developed by them will be used to choose the product or

services. SEMESTER - IV 25 M.Sc (General Biotechnology)

• A product or service is created in paper and positioned in the market. As a product

or services available only in paper to be sold in the market through the existing links.

At this juncture, the pricing of the product or the service needs to be finalized,

linking the distribution system until the product or services reaches the end

consumer.

• Candidates who have developed such product or service could present the same as a

project work to the Panel of Experts, including representatives from industry sector.

If the presented product or service is found to have real potential, the candidates

would be exposed to the next level of actual implementation of the project.

2. Go to any venture capital website (like sequoiacap.com) and prepare a proposal for

funding from

SUGGESTED READINGS:

1. Dynamics of Entrepreneurial Development & Management, Vasant Desai –

Himalaya Publishing House

2. Entrepreneurship Development –Poornima M. Charantimath – Small Business

Enterprises – Pearson Education – 2006 (2 & 4)

3. Entrepreneurship Development – S. S. Khanka – S. Chand & Co

Session: 2016-17

33


Semester 4

MPP-401

INTELLECTUAL PROPERTY RIGHTS

Maximum Marks: 100



Time: 3 hrs





UNIT-I

Intellectual Property Rights

Concepts and fundamentals: The emergence and growth of the concepts regarding

intellectual property (IP), intellectual property protection (IPP) and intellectual property

rights (IPR); economic importance, copyright, trademarks; role of IP in pharmaceutical

industry; global ramifications and financial implications.

Ethical issues in IPR/IPP (9 Lectures)

UNIT-II

Trade Related Aspects of Intellectual Property Rights

Intellectual property and international trade, concept behind WTO, WIPO, GATT, TRIPs,

TRIMS and GATS, status in India and other developing countries. (9 Lectures)

UNIT-III

Indian Patent Act. 1970 and its amendments: WTO and modifications under TRIPS, filing of

a patent application, precautions before patenting-disclosures/non-disclosures, publication-

article/thesis, prior art search – published patents search, internet search, patent sites,

specialized service search requests, costs, patent application forms and guidelines, fee

structure, time frames, jurisdiction aspects. (9 Lectures)

UNIT-IV

Technology Development/Transfer Commercialization Related Aspects Technology

development: Types of patent applications provisional, non-provisional, PCT and

convention patent applications, international patenting requirement procedures and costs.

Patent infringement: Meaning, scope, litigation, drug related patents infringements, case

studies and examples, patenting by research students. (9 Lectures)

Session: 2016-17

34

Reading Material Recommended

1. Treece DJ. Managing Intellectual Capital: Organizational, Strategic and Policy

Dimension. Oxford University Press, England. Latest Edition.

2. Wadedhra BL. Law Relating to Patents, Trademarks, Copyright Design and Geographical

Indications. Universal Law Publishing, New Delhi. Latest Edition.

3. Bansal P. IPR Handbook for Pharma Students and Researchers, Pharma Book Syndicate,

Hyderabad. Latest Edition.

4. Copyright Protection in India [website: http:copyright.gov.in].

5. Information on Orange Book [website: www.fda.gov/cder/ob/default.htm].

http://www.fda.gov/cder/ob/default.htm

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