master of pharmacy...

M. Pharm. (Pharmacology) Syllabus Applicable w.e.f. Academic Session 2011-12 (22022012) of 20

Study & Evaluation Scheme

of

Master of Pharmacy

(Pharmacology) [Applicable w.e.f. Academic Session 2011-12 till revised]

[With amendments in Credit scheme, MPL 251,351& 451 vide approval dated 17th Nov 2012]

TEERTHANKER MAHAVEER UNIVERSITY N.H.-24, Delhi Road, Moradabad, Uttar Pradesh-244001

Website: www.tmu.ac.in


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of

MASTER OF PHARMACY SUMMARY

Programme : M. Pharm. (Pharmacology)

Duration : Two years full time

Medium : English

Minimum Required Attendance : 75 percent

Credits

Maximum credits : 71

Minimum credits required for the degree : 66

Assessment : Internal External Total

30 70 100

Internal Evaluation (Theory Papers) :

Class

Test

I

Class

Test

II

Class

Test

III

Continuous

Evaluation

Seminar Total

10 10 10 5 5 30

Duration of Examination :

Theory Practical

External Internal External Internal

3 hrs. 1.5 hrs. 4 hrs. 4 hrs.

To qualify the course a student is required to secure a minimum of 40% marks in aggregate in the end

semester examination and teachers continuous evaluation (i.e. both internal and external). A candidate who

secures less than of 40% of marks in a course shall be deemed to have failed in that course. The student

should have overall 50% marks in a semester to clear the semester. In case a student has more than 40% in

each course but less than 50% overall in a semester he/she shall re-appear in one or two course(s) to improve

the percentage. There will be three Class Tests in a semester and an average of the marks obtained in best two

tests will be computed (cumulatively) for the final result.

The class tests would comprise of five questions. Student shall have to answer three questions out of which one question will be compulsory. Each question would be of five marks.

Question Paper Structure:

1. The question paper shall consist of eight questions. Out of which first question shall be of short

answer type (not exceeding 50 words) and will be compulsory. Question No. 1 shall contain 8 parts

representing all units of the syllabus and students shall have to answer any five (weightage 4 marks

each).

2. Out of the remaining seven questions, a student shall be required to attempt any five questions.

There will be minimum one and maximum two questions from each unit of the syllabus. The

weightage of Question No. 2 to 8 shall be 10 marks each.



Programme: M.Pharm. Semester I

S.N.

Course

Code

Subject Periods

C

Evaluation Scheme

L T P Internal External Total

1 MPA101 Modern Analytical

Techniques (MAT)

4 2 - 5 30 70 100

2 MPL101 Pharmaceutical Biostatistics

and Computer Applications

4 2 - 5 30 70 100

3 MPL102 Pharmacology – I

(Fundamentals of

Pharmacology)

4 2 - 5 30 70 100

4 MPA151 Modern Analytical

Techniques (MAT) Lab

- - 8 4 30 70 100

5 MPL152 Pharmacology (Fundamentals

of Pharmacology) Lab

- - 8 4 30 70 100

Total 12 6 16 23 150 350 500

Semester II

S.N.

Course

Code

Subject Periods Credits Evaluation Scheme


1 MPL201 Recent Advances in

Pharmacology

4 2 - 5 30 70 100

2 MPL202 Pharmacological Screening and

Toxicology

4 2 - 5 30 70 100

3 MPL203 Clinical Pharmacology 4 2 - 5 30 70 100

4 MPL251 Research Project Synopsis - 2 - 1 100 0 100

5 MPL252 Pharmacological Screening and

Toxicology Lab

- - 8 4 30 70 100

6 MPL253 Clinical Pharmacology Lab - - 8 4 30 70 100

Total 12 8 16 24 250 350 600

Semester III

S.N.

Course

Code



1 MPL351 Research Project Phase -I - - 48 6 100 0 100

Total - 48 6 100 0 100

Semester IV

S.N.

Course

Code



1 MPL451 Research Project Phase -II

(Thesis compilation and

Viva-Voce)

- - 48 18 25 75 100

Total - 48 18 25 75 100

Research Project shall be carried out in different stages. It will commence with submission and approval of

synopsis in second semester. The experimental work shall be carried out in two phases i.e. in III & IV

semesters.

Note: L – Lecture T- Tutorial P- Practical C- Credits

1L = 1Hr 1T= 1 Hr 1P=1 Hr 1C =1Hr of Theory paper

= 2Hrs of Practical


M. Pharm. Semester I

MODERN ANALYTICAL TECHNIQUES (MAT)

Course Code: MPA101 L-4, T-2, P-0, C-5 Objective: The basic objective of this course is to get familiar with Principle, theory & instrumentation of sophisticated pharmaceutical analysis instruments and the interpretation of their spectra.

Unit - 1

Principle, Theory & Instrumentation of UV-Visible spectroscopy. Its utility in structural qualitative and

quantitative analysis of drug molecules, woodward fischer rules and use of shiff’s reagents for

elucidation of structure. (8 Hours)

Unit – 2

Infrared spectroscopy, I.R radiation and its interaction with organic molecules, vibrational mode of

bonds, instrumentation and application, effect of hydrogen bonding and conjugation on absorption bands,

interpretation of IR Spectra, FTIR and ATR. (8 Hours)

Unit – 3

Nuclear magnetic resonance spectroscopy: chemical shift concept, isotopic nuclei, reference standards

and solvents. 1H NMR spectra, coupling constants, interpretation of spectra, decoupling-double

resonance and shift reagent methods.

Principles of FT-NMR with reference to 13C NMR, free induction decay. Spin-spin and spin-lattice

relaxation phenomenon. Nuclear overhauser enhanced 13C NMR spectra, their interpretation and

application. (8 Hours)

Unit – 4

Mass spectrometry: Basic principles and brief outline of instrumentation. Ion formation, molecular ion,

metastable ion, fragmentation process in relation to molecular structure and functional groups. Relative

abundance of isotopes, chemical ionization, GC-MS and LC/MS. Interpretation of spectra of simple

molecules. (8 Hours)

Unit – 5

Chromatographic techniques: Principles of separation and application of Column, Paper, Thin layer and

Gas chromatography, HPLC, HPTLC, Electrophoresis. Instrumentation of HPLC, Reverse phase

columns.

Pharmaceutical evaluation of drug in biological fluids- bioassays. Radioimmunoassay.

(8 Hours)

Recommended Books

1. Willard, H.H., Merrit, L.L., Dean, J.A., Settle, P.A., Instrumental Methods of Analysis, Van

Nostrand. 2. Skoog, D.A., Heller, F.J., Nieman, T.A., Principles of Instrumental Analysis, WB Saunders.

3. Haswell, S.J., ed. Atomic Absorption Spectroscopy, Elsevier.

4. Ardrey, R.E., Pharmaceutical Mass Spectra, Pharmaceutical Press, London.

5. Sethi, P.D., Quantitative Analysis of Pharmaceutical Formulations, CBS Publishers, New Delhi. 6. Kalsi, P.S., Spectroscopy of Organic Compounds, New Age Publishers, New Delhi.

7. Gross J.H., Mass Spectrometry, Springer Berlin, Heidelberg.

8. Haffmann D. H., Advances in Chromatography, Marcel Dekker.

9. Robert D. Braun, Introduction to Instrumental Analysis, McGraw-Hill.

10. Wilfried, M.A. Niessen- Liquid Chromatography-Mass Spectrometry, Marcel Dekker.

*Latest editions of all the suggested books are recommended. .


Semester I

PHARMACEUTICAL BIOSTATICS AND COMPUTER APPLICATIONS

Course Code: MPL101 L-4, T-2, P-0, C-5

Objective: The basic objective of this course is to get familiar with pharmaceutical biostatics and computer applications.

Unit - 1

Methods of collection of data, classifications and graphical representation of data. Binomial and

normal probability distribution. Polygon, histogram, measure of central tendency. Significance of

statistical methods, probability, degree of freedom, measures of variation - Standard deviation,

Standard error. (8 Hours)

Unit - 2

Sampling, sample size and power. Statistical inference and hypothesis. Tests for statistical

significance: student t-test, Chi-square test, confidence level, Null hypothesis. (8 Hours)

Unit - 3

Linear regression and correlation. Analysis of Variance (one way and two way). Factorial designs

(including fraction factorial design). Theory of probability, Permutation and Combination, Ratios, Percentage and Proportion. Two way ANOVA and Multiple comparison procedures. (8 Hours)

Unit - 4

Non-parametric tests, Experimental design in clinical trials, Statistical quality control, Validation, Optimization techniques and Screening design. Correlation and regression, least square method,

significance of coefficient of correlation, nonlinear regression. (8 Hours)

Unit - 5

Bioassays-calculations of doses response relationships, LD50, ED50.

Applications of software for statistical calculation viz. SPSS, foxtron. (8 Hours)

Book Recommended

1. Bolton, Pharmaceuticals Statistics- Practical & Clinical Applications, Marcel & Dekker, New

York.

2. Fisher, R.A., Statistical Methods for Research Works, Oliver & Boyd, Edinburgh.

3. 3. Chow, Statistical Design and Analysis of Stability Studies, Marcel Dekker, New York.

4. 4. Buncher, Statistics in the Pharmaceutical Industry, Marcel Dekker, New York.

5. 5. Finney, D.J., Statistical Methods in Biological Assays, Hafner, New York.

6. 6. Montgomery, D.C., Introduction to Statistical Quality Control, Willy.

7. 7. Lipschutz, Introduction to Probability and Statistics, McGraw-Hill.

8. 8. Li wan Po, Statistics for Pharmacist, Wiley-Blackwell.

* Latest editions of all the suggested books are recommended.


Semester I

PHARMACOLOGY – I (FUNDAMENTALS OF PHARMACOLOGY)


Objective: The basic objective of this course is to get familiar with Basic pharmacology.

Unit-1

Basic Principles of Pharmacology: Mechanisms of drug action, General aspects of receptor

pharmacology, Drug metabolism, Pharmacogenetics. (8 Hours)

Unit-2

Pharmacology of Autonomic & Somatic Nervous System: Autonomic & somatic nervous

systems, Muscarinic receptor agonists & antagonists, Anticholinesterases, Agents acting at

neuromuscular junction & autonomic ganglia,

Sympathomimetic drugs & adrenergic antagonists (8 Hours)

Unit-3

Pharmacology of Central Nervous System:Neurotransmission in CNS, Drugs used in the

treatment of:Anxiety & Psychosis, Depression & Mania, Epilepsy, CNS degenerative disorders, Parkinson’s disease (8 Hours)

Unit-4

Drugs affecting renal and cardiovascular function: Diuretics, Renin & Angiotensin System, Drugs used in the treatment of:Myocardial Ischemia Hypertension Congestive Heart Failure (CHF)

Hyperlipidemia

(8 Hours)

Unit-5 Drug addiction & drug abuse (8 Hours)

Books Recommended

1. Goodman & Gillman, The Pharmacological Basis of Therapeutics, Macmillan, ninth edition,

1995

2. Rang Dale & Ritter, Pharmacology, Churchill Livingstone, third edition, 1995.

3. Mutschler E., Deprendent H., Drug Actions: Basis Principles and Therapeutic Aspects: CRC

press 1995.

4. Katzung, Basis & Clinical Pharmacology, McGraw Hill Professional.

5. Craig C.R. & Stitzel R.E., Modern Pharmcology, Little, Brown.

6. Laurence D.R. & Benett P.N., Clinical Pharmcology, Churchill Livingstone.

7. Barar F.S.K., Essentials of Pharmcotherapeutics, S. Chand & Company Limited.

8. James Crosland, Lewis’s Pharmacology, Williams and Wilkins.



Semester I

MODERN ANALYTICAL TECHNIQUES (MAT) LAB

Course Code: MPA151 L-0, T-0, P-8, C-4

Objective: The basic objective of this course is to get familiar with different analytical instruments.

Based on the Course Code: MPA101


SEMESTER I

PHARMACOLOGY – I

(FUNDAMENTALS OF PHARMACOLOGY) LAB


Objective: The basic objective of this course is to get familiar with pharmacology practicals.

Based on the Course Code: MPL102


Semester II

RECENT ADVANCES IN PHARMACOLOGY

Course Code: MPL201 L-4, T-2, P-0, C-5 Objective: The basic objective of this course is to get familiar with advanced pharmacology.

Unit-I

Autacoids:

Histamine, Serotonin, Bradykinin & their antagonists

Eicosanoids & PAF

Anti-inflammatory, analgesic & antipyretic agents

Anti-asthmatic agents (8 Hours)

Unit-II

Drugs affecting gastro intestinal function:

Agents for control of acidity and antiulcer drugs

Emetics & anti emetics. (8 Hours)

Unit-III

Principles of Chemotherapy:

Chemotherapeutic agents:

a. Fluroquinolones

b. Cephalosporin and other newer agents

c. Antifungal & antiviral drugs

d. Chemotherapy of Neoplastic diseases (8 Hours)

Unit-IV

Gene therapy:

a. General concept of gene therapy

b. Gene therapy for hereditary diseases, cancer & HIV

c. Antisense therapy (8 Hours)

Unit-V

Immunopharmacology: a. Immunosuppressive agents, Immunomodulators

b. Current concepts in pharmacotherapy of HIV

c. In vitro and in vivo tests for immunological investigation (8 Hours)

Books Recommended

1. Goodman & Gillman, The Pharmacological Basis of Therapeutics, MacMillan, 1995

2. Rang Dale & Ritter, Pharmacology, Churchill Livingstone, 1995.

3. Mutschler E., Deprendent H., Drug Actions: Basis Principles and Therapeutic Aspects: CRC press 1995.

4. Katzung, Basis & Clinical Pharmacology, McGraw Hill Professional.

5. Craig C.R. & Stitzel R.E., Modern Pharmacology, Little Brown.

6. Laurence D.R. & Benett P.N., Clinical Pharmacology, Churchill Livingstone.

7. Barar F.S.K., Essentials of Pharmcotherapeutics, S. Chand & Company Limited.

8. James Crossland, Lewis’s Pharmacology, Williams and Wilkins.

* Latest editions of all the suggested books are recommended


Semester - II

PHARMACOLOGICAL SCREENING & TOXICOLOGY


Objective: The basic objective of this course is to get familiar with pharmacological screening and

toxicology.

Unit-I

Drug discovery process: Principles, techniques & strategies used in new drug discovery

Principles of toxicity evaluations

High throughput screening

Regulations for laboratory animal care and ethical requirements (8 Hours)

Unit-II Pharmacological screening of new drugs belonging to following categories: Antipsychotic agents,

anti-anxiety agents, nootropic drugs, antidepressant drugs, anti-parkinsonian drugs, antiepileptic.

(8 Hours)

Unit-III

Pharmacological screening of new drugs belonging to following categories: Analgesics & anti-

inflammatory agents, antiulcer, antihypertensives, antiarrhythmic agents, antiatherosclerotic drugs,

antidiabetic, antifertility agents (8 Hours)

Unit-IV

Principles of toxicology:

Abnormal action of drugs; tolerance, addiction, habituation, idiosyncracy, allergy, hypersensitivity,

antagonism, synergism, potentiating, tachyphylaxis, teratogenicity & Mutagenicity. (8 Hours)

Unit-V

Heavy Metals Poisoning. (8 Hours)

Books Recommended

1. Turner R.I., Screening Methods in Pharmacology, Academic Press, 1965.

2. Laurance & Bacharch, Pharmacometrics, VOL. I & II, Academic Press.

3. Seth U.K., Dadkar Kamathy, Eperimental Topics in Pharmacology, Academic Press Inc.

4. Floyd R. Domer, Animal Experimental in Pharmacological Analysis. Thomas.

5. Ian Kitchen, In vitro Experiments in Pharmacology, Blackwell Scientific Publications, 1984.

6. Ghosh M.N., Fundamental of Experimental Pharmacology, Scientific Book Agency, 1984.



Semester – II

CLINICAL PHARMACOLOGY


Objective: The basic objective of this course is to get familiar with clinical pharmacology.

Unit-I

Principles of Clinical Pharmacokinetics:

a. Dose -response in human

b. Influence of renal and hepatic disease on pharmacokinetics

c. Therapeutic drug monitoring (TDM)

d. Population pharmacokinetics; Racial, gender & ethnic differences in drugs response

(8 Hours)

Unit-II Clinical evaluation of drug: Evaluation of drug in human, terminologies, organization, types of clinical

research and phases of clinical evaluation of drug (8 Hours)

Unit-III

Adverse Drug Reactions (ADR) & Pharmacovigilance (8 Hours)

Unit-IV

Pharmacotherapy and management of the following disorders: a. Hepatic disorders: cirrhosis, hepatitis.

b. Renal diseases: Acute and chronic renal failure, renal dialysis and transplantation, drug doses

in renal impairment.

c. Respiratory diseases: asthma, chronic obstructive pulmonary edema, pulmonary embolism.

(8 Hours)

Unit-V

Pharmacotherapy and management of the following disorders: a. Endocrine disorders: diabetes, obesity.

Infectious diseases: tuberculosis, leprosy, urinary & gastrointestinal tract infections, fungal

and viral infection. General guidelines for rational use of antibiotics, resistance to antibiotics.

(8 Hours)

Books Recommended

1. Grahame – smith D.G. and Aronson J.K., Oxford Text Book of Clinical Pharmacology and Drug

Therapy, Oxford University.

2. Katzung, Basic and Clinical Pharmacology, McGraw Hill Professional, 1995 edition

3. Drug actions: Basic Principles and Therapeutic Aspects: Ernest Muscular Harmat Desendor Press,

1995

* Latest editions of all the suggested books are recommended


Semester –II

RESEARCH PROJECT SYNOPSIS [Amended vide approval dated 17

th Nov 2012]

Course Code: MPL251 L- 0, T-2, P-0, C-1

Objective: The basic objective of this course is to get familiar with the method, instrumentation

and the technology of the topic that is selected for the dissertation.

Guidelines: 1. The course will comprise of preparation of synopsis for the proposed research work to be done

during third and fourth semester courses.

2. The allotted supervisor will provide guidelines and determine the topic of the research work

based on thorough literature reviews.

3. The final presentation will be evaluated by the College CRC and the supervisor(s) based on

the quality of the work and its relevance in the pharmaceutical field.


EVALUATION SHEET

Name of Candidate:

Roll No:

Class and Section:

Please evaluate out of marks as indicated.

Subject Code:

Subject: RESEARCH PROJECT SYNOPSIS

Name of Candidate: Roll No:


S.N

o

Details Examiner I Examiner II Examiner III Average

Marks (25) Marks (25) Marks (25) Marks

(25)

Maximum marks in each column ( 5 marks x5) (5 marks x5) (5 marks x5)

1 OBJECTIVE IDENTIFIED & UNDERSTOOD

2

LITERATURE REVIEW / BACKGROUND

WORK

(Coverage, Organization, Critical review)

3 DISCUSSION/CONCLUSIONS

(Clarity, Exhaustiveness)

4 SLIDES/PRESENTATION SUBMITTED

(Readable, Adequate)

5

FREQUENCY OF INTERACTION ( Timely

submission, Interest shown, Depth,

Attitude)

Total

Signature with date

Signature and date of the Director/

Principal


Semester - II

PHARMACOLOGICAL SCREENING & TOXICOLOGY LAB


Objective: The basic objective of this course is to get familiar with pharmacological screening and

toxicology practicals.

Based on the Course Code MPL202


Semester - II

CLINICAL PHARMACOLOGY LAB


Objective: The basic objective of this course is to get familiar with clinical pharmacology practicals.

Based on the Course Code MPL203


Semester III

RESEARCH PROJECT (PHASE-I) [Amended vide approval dated 17

th Nov 2012]

Course Code: MPL351 L- 0, T-0, P-48, C-6

Objective: The basic objective of this course is to represent the findings of the project that has been

done in the dissertation.

Guidelines: 1. The course will comprise of the confirmation of the proposed research work based on the initial

experimentation to confirm the feasibility of the work.

2. The allotted supervisor(s) will provide guidelines with exploration of the line of action with

recent trends of research in the related field and confirm global acceptability with regards to industry

and academic problems.

3. The continuous literature survey and modification of experimental pathway will be taken in to

practice with regular monitoring.

4. The candidate’s performance will be evaluated as follows:

There will be at least two seminars to be presented before the CRC during the semester consisting of the

progress of the research work. An end semester seminar will be held in the month of December/ January

under .The assessment will be 100 % internal the college committee will include at least following 3

members:-

• Seminar in-charge

• Supervisor

• Head of the department/ faculty member from the specialized field other than the supervisor

nominated by HOD

The information of the seminar will be given to the examination department. The examination

department may appoint an observer to the seminars from other college/ department with the approval of

the Vice Chancellor.

The marks will be forwarded to the University examination department immediately after the seminars.


Subject Code: Subject: RESEARCH PROJECT PHASE I



S.N

o


Marks (50) Marks (50) Marks 505) Marks

(50)

Maximum marks in each column (15 marks x5) (10 marks x5) (10 marks x5)


2


WORK






5



Attitude)

Total

Signature with date

Signature and date of the Director


Semester IV

RESEARCH PROJECT (PHASE –II)

(THESIS COMPILATION & VIVA-VOCE) [Amended vide approval dated 17

th Nov 2012]


Dissertation work

1. The student shall meet the guide frequently for the necessary guidance for the Thesis work.

2. During the semester as well as the semester break, student should read the literature germane to the

thesis topic. The progress of the Research / thesis work should continuously be informed to the guide.

3. In the end after necessary collection of data, literature survey and research work, the student must

prepare a thesis report (Final Report). The report shall be arranged and bind in the sequence consisting

of the following:-

Format of dissertation:

At the end of the IV semester the student will submit the dissertation based on the recommendation of

the student guide’s as per the format approved by the college.

The assessment will be 25% internal and 75% external


INTERNAL ASSESSMENT

Subject Code: Subject: RESEARCH PROJECT PHASE II



S.N

o


Marks (25) Marks (25) Marks (25) Marks

(25)

Maximum marks in each column ( 5 marks x5) (5 marks x5) (5 marks x5)


2


WORK






5



Attitude)

Total

Signature with date

Signature and date of the Director


EXTERNAL ASSESSMENT

Subject Code: Subject: RESEARCH PROJECT PHASE II


EVALUATION BY EXTERNAL EXAMINER

Roll

No

Student Name Criteria -1 Criteria -2 Criteria -3 Criteria -4 Criteria 5 Total

Marks (15) Marks (15) Marks (15) Marks (15) Marks (15) Marks

(75)

Criteria

No

Details of the criteria for evaluation


2 LITERATURE REVIEW / BACKGROUND WORK






5 FREQUENCY OF INTERACTION ( Timely submission, Interest shown, Depth, Attitude)

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