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© CHARUSAT 2012 of 49

ACADEMIC

REGULATIONS &

SYLLABUS

Faculty of Pharmacy

Master of Pharmacy Programme (Clinical Pharmacy)

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CHAROTAR UNIVERSITY OF

SCIENCE & TECHNOLOGY

Education Campus – Changa, (ECC), hitherto a conglomerate of institutes of professional

education in Engineering, Pharmacy, Computer Applications, Management, Applied Sciences,

Physiotherapy and Nursing, is one of the choicest destinations by students. It has been transformed

into Charotar University of Science and Technology (CHARUSAT) through an Act by

Government of Gujarat. CHARUSAT is permitted to grant degrees under Section-22 of UGC-

Govt. of India.

The journey of CHARUSAT started in the year 2000, with only 240 Students, 4 Programmes, one

Institute and an investment of about Rs. 3 Crores (INR 30 million). At present there are seven

different institutes falling under ambit of six different faculties. The programmes offered by these

faculties range from undergraduate (UG) to Ph.D degrees including M.Phil. These faculties, in all

offer 23 different programmes. A quick glimpse in as under:

Faculty Institute Programmes Offered

Faculty of Technology & Engineering Charotar Institute of Technology B.Tech

M.Tech

Ph.D Faculty of Pharmacy Ramanbhai Patel College of Pharmacy B.Pharm

M.Pharm

Ph.D Faculty of Management Studies Indukaka Ipcowala Institute of

Management M.B.A

PGDBM

Ph.D Faculty of Computer Applications Charotar Institute of Computer

Applications M.C.A

Ph.D Faculty of Applied Sciences P.D.Patel Institute of Applied Sciences M.Sc

M.Phil

Ph.D Faculty of Medical Sciences Charotar Institute of Physiotherapy

Charotar Institute of Nursing

B.PT

B.Sc (Nursing)

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The development and growth of the institutes have already led to an investment of over Rs.63

crores (INR 630 Million). The future outlay is planned with an estimate of Rs. 250 Crores (INR

2500 Million).

The University is characterized by state-of-the-art infrastructural facilities, innovative teaching

methods and highly learned faculty members. The University Campus sprawls over 100 acres of

land and is Wi-Fi enabled. It is also recognized as the Greenest Campus of Gujarat.

CHARUSAT is privileged to have 300 core faculty members, educated and trained in Stanford,

IITs, IIMs and leading Indian Universities, and with long exposure to industry. It is also proud of

its past students who are employed in prestigious national and multinational corporations.

From one college to the level of a forward-looking University, CHARUSAT has the vision of

entering the club of premier Universities initially in the country and then globally. High Moral

Values like Honesty, Integrity and Transparency which have been the foundation of ECC

continue to anchor the functioning of CHARUSAT. Banking on the world class infrastructure and

highly qualified and competent faculty, the University is expected to be catapulted into top 20

Universities in the coming five years. In order to align with the global requirements, the University

has collaborated with internationally reputed organizations like Pennsylvania State University –

USA, University at Alabama at Birmingham – USA, Northwick Park Institute –UK, ISRO, BARC,

etc.

CHARUSAT has designed curricula for all its programmes in line with the current international

practices and emerging requirements. Industrial Visits, Study Tours, Expert Lectures and

Interactive IT enabled Teaching Practice form an integral part of the unique CHARUSAT

pedagogy.

The programmes are credit-based and have continuous evaluation as an important feature. The

pedagogy is student-centred, augurs well for self-learning and motivation for enquiry and research,

and contains innumerable unique features like:

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• Participatory and interactive discussion-based classes.

• Sessions by visiting faculty members drawn from leading academic institutions and industry.

• Regular weekly seminars.

• Distinguished lecture series.

• Practical, field-based projects and assignments.

• Summer training in leading organizations under faculty supervision in relevant programmes.

• Industrial tours and visits.

• Extensive use of technology for learning.

• Final Placement through campus interviews.

Exploration in the field of knowledge through research and development and comprehensive

industrial linkages will be a hallmark of the University, which will mould the students for global

assignments through technology-based knowledge and critical skills.

The evaluation of the student is based on grading system. A student has to pursue his/her

programme with diligence for scoring a good Cumulative Grade Point Average (CGPA) and for

succeeding in the chosen profession and life.

CHARUSAT welcomes you for a Bright FutureCHARUSAT welcomes you for a Bright FutureCHARUSAT welcomes you for a Bright FutureCHARUSAT welcomes you for a Bright Future

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CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY

Faculty of Pharmacy

ACADEMIC REGULATIONS M. Pharm. (Clinical Pharmacy) Programme

Charotar University of Science and Technology (CHARUSAT) CHARUSAT Campus, At Post: Changa – 388421, Taluka: Petlad, District: Anand

Phone: 02697-247500, Fax: 02697-247100, Email: [email protected] www.charusat.ac.in

Year – 2012

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CHARUSAT

FACULTY OF PHARMACY ACADEMIC REGULATIONS

M. Pharm. (Clinical Pharmacy) Programme

To ensure uniform system of education, duration of post graduate programmes, eligibility criteria for and mode of admission, credit load requirement and its distribution between courses and system of examination and other related aspects, following academic rules and regulations are recommended.

1. System of Education

The Semester system of education should be followed across The Charotar University of Science and Technology (CHARUSAT) at Master’s levels. Each semester will be at least of 90 working days duration. Every enrolled student will be required to take a specified load of course work in the chosen subject of specialization and also complete a project/dissertation if any. 2. Duration of Programme

Postgraduate programme (M.Pharm)

Minimum 4 semesters (2 academic years) Maximum 6 semesters (3 academic years)

Maximum limit can be extended by one or two semesters subject to approval of University on case to case basis.

3. Eligibility for admissions

As decided from time to time by the Government of Gujarat and CHARUSAT

4. Mode of admissions

As decided from time to time by the Government of Gujarat and CHARUSAT

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5. Programme structure and Credits A student admitted to a program should study the courses and earn credits specified in the course structure. Please refer detailed syllabus.

6. Attendance

All activities prescribed under these regulations and listed by the course faculty members

in their respective course outlines are compulsory for all students pursuing the M. Pharm. programme. No exemption will be given to any student from attendance except on account of serious personal illness or accident or family calamity that may genuinely prevent a student from attending a particular session or a few sessions. However, such unexpected absence from classes and other activities will be required to be condoned by the Principal.

Student attendance in a course should be 80%.

7. Course Evaluation 7.1 The performance of every student in each course will be evaluated as follows:

7.1.1. Internal evaluation by the course faculty member (s) based on continuous assessment, for 30% of the marks for the course; and

7.1.2 Final examination by the University through written paper or practical test or oral test or presentation by the student or a combination of any two or more of these, for 70% of the marks for the course.

7.1.3 Theory and Practical component of the same course shall be considered as separate courses.

7.2 Internal Evaluation (Theory)

The distribution of marks for calculating the internal marks in every course of theory shall be:

Test * 20 Marks Seminar/quiz/viva 10 Marks ___________________________________________________________________________

Total 30 Marks

* One test (60 marks, 2.5 hours duration) shall be conducted as per the schedule to be notified by the institute for every course in a semester.

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7.3. Internal evaluation (Practicals)

The distribution of marks for calculating the internal marks in every course of practical shall be:

Performance of the exercises * 15 Marks Viva 10 Marks Quiz 05 Marks

Total 30 Marks

*One test (60 marks, 6 hours duration) shall be conducted as per the schedule to be notified by the Institute for every course of practical in a semester.

7.4 University Examination

7.4.1 The final examination by the University for 70% of the evaluation for the course will be through written paper or practical test or oral test or presentation by the student or a combination of any two or more of these.

In order to earn the credit in a course a student has to obtain grade other than FF.

7.5 Performance at University Examination 7.5.1 Minimum performance with respect to university examination as well as overall

(university + internal) will be an important consideration for passing a course. Details of minimum percentage of marks to be obtained in the examinations are as

follow

Minimum marks in University Examination for every course

Minimum marks Overall (internal + university examination) for every course

40% 50%

7.5.2 If a candidate obtains minimum required marks per course in university examination but fails to obtain minimum required overall marks, he/she has to repeat the university examination till the minimum required overall marks are obtained.(As per the clause 7.5.1)

8. Grading

8.1 The total of the internal evaluation marks and final University examination marks in each course will be converted to a letter grade as well as to a ten-point scale as per the following scheme:

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Grading Scheme:

Range of Marks (%) ≥80 <80

≥75

<75

≥70

<70

≥65

<65

≥60

<60

≥55

<55

≥50

<50

Letter Grade AA AB BB BC CC CD DD FF Grade Point 10 9 8 7 6 5 4 0

8.2 The student’s performance in any semester will be assessed by the Semester Grade Point

Average (SGPA). Similarly, his/her performance at the end of two or more consecutive semesters will be denoted by the Cumulative Grade Point Average (CGPA). The SGPA and CGPA are defined as follows:

(i) SGPA = ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i

Gi is the Grade Point for the course i and i = 1 to n, n = number of courses in the semester

(ii) CGPA = ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i Gi is the Grade Point for the course i

and i = 1 to n, n = number of courses of all semesters up to which CGPA is computed.

No student will be allowed to move further if CGPA is less than 3 at the end of every academic year.

9. Award of Degree

9.1 Every student of the programme who fulfils the following criteria will be eligible for the award of the degree: 9.1.1 He/She should have earned at least minimum required credits as prescribed in

course structure; and 9.1.2 He/She should have cleared all external and overall evaluation components in every

course; and He/She should have secured a minimum CGPA of 5.0 at the end of the programme; In addition to above, the student has to complete the required formalities as per the

regulatory bodies, if any.

9.2 The student who fails to satisfy minimum requirement of CGPA will be allowed to improve the grades so as to secure a minimum CGPA for award of degree. Only latest grade will be considered.

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10. Award of Class The class awarded to a student in the programme is decided by the final CGPA as per the following scheme: Distinction: CGPA ≥ 7.5 First class: CGPA≥ 6.0 & <7.5 Second Class: CGPA≥ 5.0 & <6.0

11. Transcript The transcript issued to the student at the time of leaving the University will contain a consolidated record of all the courses taken, credits earned, grades obtained, SGPA,CGPA, class obtained, etc.

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CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY M. Pharm. (Clinical Pharmacy)

SEMESTER-1

Scheme of Teaching

Scheme of Evaluation

Course Theory Practical Project

Code Name University Institute Seminar Total University Institute Total University Institute Total

PH821 Analytical Techniques 70 30 -- 100 70 30 100 -- -- --

PH861.01

Biological evaluation of Drugs

70 30 -- 100 70 30 100 -- -- --

PH864 Pharmacology and Pharmacotherapeutics-I

70 20 10 100 -- -- -- -- -- --

PH871 Hospital Pharmacy 70 20 10 100 -- -- -- -- 50 --

PH883 Pharmacokinetics 70 30 -- 100 -- -- -- -- -- --

Total 350 130 20 500 140 60 200 -- 50 50

Total marks of 1st semester: 750

Course Contact Hours/Week Credits

Code Name Theory Seminar Practical Project Total Theory+

Seminar Practical Project Total

PH821 Analytical Techniques 3 -- 6 -- 9 3 3 -- 6

PH861.01 Biological evaluation of Drugs

3 -- 4 -- 7 3 2 -- 5

PH864 Pharmacology and Pharmacotherapeutics-I

4 2 -- -- 6 6 -- -- 6

PH871 Hospital Pharmacy 3 2 -- 6 11 5 -- 3 8

PH883 Pharmacokinetics 3 -- -- -- 3 3 -- -- 3

Total 16 4 10 6 36 20 5 3 28

Total Credits of 1st semester: 28

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SEMESTER-2

Scheme of Teaching



Code Name University Institute

Total University Institute Total University Institute Total Theory seminar

PH823 Biostatistics 35 15 -- 50 70 30 100 -- -- --

PH824 Research Methodology 70 30 -- 100 -- -- -- -- -- --

PH866 Pharmacology &

Pharmacotherapeutics –II

70 20 10 100 -- -- -- -- -- --

PH872 Clinical Research 70 20 10 100 -- -- -- -- -- --

PH873 Pharmacy Practice 70 30 -- 100 -- -- -- -- 50 50

PH874 Dissertation Part-I -- -- -- -- -- -- -- -- 50 50

Total 315 115 20 450 70 30 100 -- 100 100

Total Marks of 2nd Semester: 650


Code Name Theory Seminar Practical Project Total Theory+

Seminar Practical

Project

Total

PH823 Biostatistics 2 -- 4 -- 6 2 2 -- 4

PH824 Research Methodology 4 - - - 4 4 - - 4

PH866 Pharmacology & Pharmacotherapeutics-II

4 2 - - 6 6 - - 6

PH872 Clinical Research 4 2 - - 6 6 - - 6

PH873 Pharmacy Practice 2 - - 6 8 2 - 2 4

PH874 Dissertation Part-I - - - 6 6 - - 2 2

Total 16 4 4 12 36 20 2 4 26

Total Credits of 2nd semester: 26

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CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY

M. Pharm. (Clinical Pharmacy)

SEMESTER-3 Scheme of Teaching

Course Contact Hours/Week Credits Code

Name Theory

Practical Project Total Theory Practical Project Total

PH921

Drug Regulatory Affairs and Intellectual Property Rights

4 -- -- 4 4 -- -- 4

PH971 Dissertation Part-II

-- -- 32 32 -- -- 22 22

Total 4 -- 32 36 4 -- 22 26

Total credits of 3rd semester: 26



Code Name University Institute Total University Institute Total University Institute Total

PH921

Drug Regulatory Affairs and Intellectual Property Rights

70 30 100 -- -- -- -- -- --

PH971 Dissertation Part-II

-- -- -- -- -- -- 400 150 550

Total 70 30 100 -- -- -- 400 150 550

Total marks of 3rd semester: 650

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SEMESTER-4

Scheme of Teaching

Part-I (10 weeks)


Code Name Theory Practical Project Total Theory Practical Project Total

PH972 Dissertation Part-III

-- -- 36 36 -- -- 26 26

Part-II (5 weeks)

PH973 Training * - - - - - - 2 2

Total 28 28

Total Credit of 4th Semester: 28

* Training to be undertaken in a Hospital/Clinical Research Organization/In house project in consultation with Research supervisor.



University Institute Total University Institute Total University Institute Total Code Name

PH972 Dissertation Part-III

-- -- -- -- -- -- 500 150 650

PH973 Training -- -- -- -- -- -- - 50 650

Total - - - - - - 500 200 700

Total Marks of 4th

Semester: 700

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SYLLABI (Semester – 1)


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ANALYTICAL TECHNIQUES (PH821) (Theory & Practical)

Credits: 3: Theory Contact hrs per week: 3: Theory 3: Practical 6: Practical

Objective of the Course:

To make students familiar with the principles of modern analytical techniques and it’s application in

pharmacy.

Student Learning Outcomes/Objectives: At the end of the course, the student will be able to understand the fundamental concept of modern

analytical techniques, which is important for qualitative as well as quantitative analysis of drug

substances and drug product.

Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector. Outline of the Course:

No. Unit Minimum No.

of Contact Hours Approx.

Weightage % 1 UV – Visible spectroscopy 6 14 2 Infrared spectroscopy 4 8

3 Nuclear Magnetic Resonance Spectroscopy

8 20

4 Mass Spectroscopy 6 14 5 Thermal Methods of Analysis 3 6 6 X-Ray Diffraction Methods 3 6 7 Chromatographic techniques 8 20 8 Analytical Method Validation 2 3 9 Electrophoresis 3 6

10

Application of Transmittance Electron Microscopy (TEM) and Scanning Electron Microscopy (SEM).

2 3

Total 45 100 %

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Detailed Syllabus (Theory):

No. Unit Details Hrs.

1. UV – Visible spectroscopy: Theory, chromophores and their interaction with EMR, solvent effects,

instrumentation (components and their function) & applications including multi-component assay

and derivative spectra. Woodward-Fischer rules for calculating absorbance maximum and

interpretation of spectra.

6

2. Infrared spectroscopy: Introduction, basic principles, instrumentation (components and their

function), sampling techniques, interpretation of spectra and applications. Theory and applications

of FTIR, ATR and NIR.

4

3. Nuclear Magnetic Resonance Spectroscopy: Fundamental principle and theory of proton NMR,

instrumentation, solvents, chemical shift, spin-spin coupling, coupling constant, spin-spin

decoupling, proton exchange reactions, simplification of complex spectra, FT-NMR, 2D-NMR,

applications in pharmacy and interpretation of spectra. 13 C-NMR introduction, natural abundance,

13 C-NMR spectra and its structural applications.

8

4. Mass Spectroscopy: Basic principle and instrumentation, ion formation and type, fragmentation

process and fragmentation pattern, chemical ionization mass spectroscopy (CIMS), field ionization

MS (FIMS), Fast atom bombardment MS (FAB-MS), matrix assisted laser desorption/ ionization

MS (MALDI-MS), Interpretation of spectra and application in pharmacy, Surface Ionization MS(SI-

MS).

6

5. Thermal Methods of Analysis: Theory, instrumentation and application of thermogravimetric

analysis (TGA), Differential Thermal Analysis (DTA), Differential Scanning Calorimetry (DSC) and

Thermo Mechanical Analysis (TMA).

3

6. X-Ray Diffraction Methods: Introduction, generation of X-rays, X-ray diffraction, Bragg’s Law, X-ray

powder diffraction, interpretation of diffraction pattern and applications. 3

7. Chromatographic techniques: Classification of chromatographic methods based on mechanism of

separation. Theories of chromatographic separation. Principles, elution techniques, instrumentation,

derivatization and application of GC, HPLC, HPTLC. Principles, elution techniques, applications of

ion exchange and ion pair chromatography, affinity chromatography, Size exclusion

chromatography, chiral chromatography, super fluid chromatography (SFC), GC-MS, short column

chromatography, flash chromatography, medium pressure LC and LC-MS.

8

8. Analytical Method Validation: Basis concepts for development and validation of analytical and bio

analytical method as per ICH guidelines. 2

9. Electrophoresis: Theory and principles, classifications, instrumentation, moving boundary

electrophoresis, Zone Electrophoresis (ZE), Isoelectric focusing (IEF) and applications. 3

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10. Application of Transmittance Electron Microscopy (TEM) and Scanning Electron Microscopy

(SEM). 2

Detailed syllabus (Practicals): To illustrate the topics included under theory.

Recommended study materials:

1. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Saunders College Publishers,

Philadelphia.

2. Instrumental Methods of Analysis, Willard, Merritt, Dean and Settle, CBS publishers and

Distributers, Delhi.

3. Instrumental Methods of Chemical Analysis, G. W. Ewing, McGraw Hill Book Co, NY.

4. Instrumental Methods of Chemical Analysis, B.K. Sharma, Goel Publication House, Meerut, India.

5. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacoppeal convention, INC,

12601 Twinbrook Parkway, Rockville, MD 20852.

6. British Pharmacopoeia, 2004, The British Pharmacopoeia commission office, Market Tower, Nine

Elms Lane, London.

7. Indian Pharmacopoeia-2007, Indian pharmacopoeia commission, Sector-23, Raj Nagar,

Ghaziabad.

8. Remington’s Pharmaceutical Sciences, J. P. Remington, Mack Pub. Co., Pennsylvania.

9. Statistics for Analytical Chemists, T Caulcutt and R. Boddy, Chapman & Hall, London.

10. Modern Methods of Pharmaceutical Analysis, Vol 1, 2, RE Schirmer, Franklin Book Co, PA.

11. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler, T.C. Morrill,

Pub: John Wiley and Sons, NY.

12. Spectroscopic identification of organic compounds. John Dyer, Willy, NY.

13. Organic Spectroscopy W. Kemp, NY.

14. NMR spectroscopy (Basic Principles, concepts and application in Chemistry) Herald Gunther,

(John Wiley and Sons), NY.

15. Fundamentals of Mathematical Statistics, S.C. Gupta and V.K. Kapoor (Sulthyan Chand and

Sons), New Delhi.

16. Pharmaceutical Analysis – Modern Methods – Part A, Part B, J. W. Munson, Marcel Dekker, NY.

17. Practical Pharmaceutical Chemistry, Part two, edited by A. H. Beckett & J. B. Stenlake

18. Identification of Drugs and Pharmaceutical Formulations by Thin Layer Chromatography, 2nd

Edition, P. D. Sethi, CBS Publishers and Distributers, New Delhi.

19. HPTLC – Quantitative Analysis of Pharmaceutical Formulations – P. D. Sethi, CBS Publishers and

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Distributers, New Delhi.

20. Stereo Chemistry – Conformation and Mechanism by P. S. Kalsi, New Age International

Publishers.

21. Chromatographic Analysis of Pharmaceuticals, A. John, Adamovics, Cytogan Corporation,

Princeton, NJ.

22. Clerk’s analysis of Drugs and Poisons, A.C. Moffet, M. D. Osselton, B. Widdop L. Y. Galichet,

Pharmaceutical Press.

23. Relevant articles from journals.

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BIOLOGICAL EVALUATION OF DRUGS (PH861.01) (Theory & Practical)

__________________________________________________________________________________ Credits: 3: Theory Contact hrs per week: 3: Theory

2: Practical 4: Practical


To make students familiar with methodology in Drug screening.

Student Learning Outcomes/Objectives:

At the end of the course, the student will be able to learn the basic techniques to evaluate drugs using

various animal models for different pathological conditions.

Instructional Methods and Pedagogy:

Faculty member/s shall explain in a class room using black board and multimedia projector.

Outline of the Course:

Sr. No. Unit Minimum No. of

Contact Hours

Approx. Weightage

%

1 Drug discovery process 5 11

2 General Principles of

screening

7 16

3 Bioassays of drug 5 11

4 Biological evaluation of drugs 28 62

Total 45 100 %


1 New approaches in drug discovery. Combinatorial chemistry, High throughput screening,

ultra high throughput screening, and high content screening, Technologies for high

throughput screening Pharmacogenomics, Proteomics, Array technology, Invitro

pharmacokinetic analysis, Correlation between invitro and invivo screens, Determination of

errors in screening procedures.

5

2 General Principles of screening, Laboratory animals, Maintaining and handling of animals,

Basic laboratory animal data, Breeding of lab animals, Animal strains and their applications,

knock out and transgenic animals

7

3 Bioassays: Basic principles of bioassays of some official drugs, experimental models and 5

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statistical designs employed in biological standardization. Biological standardization of

vaccines and sera with certain examples with reference to IP. Development of new bio assay

methods.

4 Biological evaluation of drugs:

Screening and evaluation ( including principles of screening , development of models for

diseases : In vivo models / In vitro models / Cell line study techniques of the following:

1. Parasympathomimetics, Parasympathetic blocking agents, Sympathomimetics, Sympathetic

blocking agents, Ganglion stimulants and blockers, Neuromuscular stimulants and

blockers.

2. General and local Anesthetics, Sedatives and Hypnotics, Antiepileptics,

Psychopharmacological agents, Analgesics, Antiinflammatory agents, Anti Parkinson’s

drugs, CNS Stimulants.

3. Cardiotonics, Antihypertensive drugs, Antiarrhythmic drugs, Drugs used in Ischemic Heart

Diseases, Drugs used in Atherosclerosis.

4. Drugs used in Peptic Ulcer, Respiratory disorders, Hormone and Endocrine disorders.

Antifertility agents and diuretics.

5. Various models for Cataract, Glaucoma, Inflammatory Bowel Disease

28

Detailed Syllabus (Practical):

Evaluation of drugs based on theory syllabus.

Illustrative examples:

Central nervous system:

1. Determination of the time required for induction and recovery from anesthesia for various volatile

general anesthetics.

2. Evaluation of the effect of pentobarbitone sodium and diazepam in mice.

3. Evaluation of the effect of various tranquilizers and sedatives on motor coordination by rota rod test

in mice.

4. Evaluation of CNS stimulant /depressant effect of drugs through spontaneous motor activity using

photoactometert.

5. Evaluation of the antiparkinsonian activity of drugs by phenothiazine induced catatonia.

6. Evaluation of the effect of psychotropic drugs on condition avoidance response.

7. Evaluation of the compulsive behavior (stereotypy) induced by apomorphine and its modification by

chlorpromazine in mice.

8. Evaluation of anxiolytic (antianxiety) effect of diazepam in mice using elevated plus maze apparatus.

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9. Evaluation of analgesic effects of drugs by different methods: Thermal method, Chemical method

10. Evaluation of the anti-inflammatory property of indomethacin against carrageenan induced acute

paw edema in rats.

Gastro intestinal system:

1. Evaluation of the effect of ranitidine in drug induced gastric (peptic) and duodenal ulcers and hyper

secretion of gastric acid in rats.

2. Evaluation of the antisecretory and ulcer protective effect of ranitidine in pylorus ligated rats.

3. Evaluation of the antiepileptic activity of drug using maximum electro convulsive shock seizures (M.

E. S.) and chemical induced convulsions methods.

Genitourinary system

1. Evaluation of the effects of various drugs (diuretics) on the output of the urine in rats.

Recommended Study material

1. Screening methods in pharmacology (Vol: I & II)–R.A. Turner, Academic Press, New York, 1965.

2. Drug Discovery and Evaluation in Pharmacology assay: Vogel Library of Congress Cataloging in

Publication Data

3. Design and analysis of animal studies in pharmaceutical development, Chow, Shein,

Ching, Chapman & Hall/CRC.

4. Evaluation of Drug Activity: Pharmacometrics D.R. Laurence, Academic Press, 1964.

5. Animal and Clinical pharmacologic Techniques in Drug Evaluation-Nodine and

Siegler, Chicago: Year Book Medical Publishers, 1964

6. Pharmacology and Toxicology- Kale S.R., 6th edition, Nirali Prakashan, 2003.

7. Fundamentals of experimental Pharmacology. Ghosh M.N. Scientific book agency, Calcatta.

8. Goyal R.K. Practicals in pharmacology. M/s B.S.Shah Prakashan, Ahmedabad.

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

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PHARMACOLOGY & PHARMACOTHERAPEUTICS -I (PH864) (Theory)

Credits: 4: Theory Contact hrs per week: 4: Theory 2: Seminar 2: Seminar Objective of the Course:

To make students familiar with Pharmacological and Pathophysiological basis of drug treatment.


At the end of the course, the student will be able to understand the Pharmacology &

pathophysiological & therapeutical basis of drug treatment.




Sr. No.

Unit Minimum No. of Contact Hours

Approx. Weightage %

1 Cardiovascular and Hemopoietic

system

24

45

2 Endocrine system 6 10

3 Gastro-intestinal System 6 10

4 Urogenital system 6 10

5 Eyes 5 5

6 Infectious Diseases 13 20

Total 60 100%

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Systemic Pharmacology of the given system, important disorders/conditions (Pathology, etiology, complications, diagnosis, Prognosis), their control and management with special emphasis on pharmacology of drugs (mechanism of action, ADME, therapeutics, adverse effects, toxicities and possible drug interaction) of the following: 1. Cardiovascular and Hemopoietic system; 24 Hypertension, Acute Coronary Syndrome, Angina Pectoris, Atherosclerosis, Congestive Heart Failure, Arrhythmias, Thromboembolic disorder, Anaemia & their types 2. Endocrine system: 06 Disorders of Thyroid gland and Parathyroid gland, Diabetes mellitus, Adrenocortical dysfunction 3. Gastro-intestinal System: 06 Peptic Ulcer, Inflammatory Bowel Disease, Liver diseases 4. Urogenital system: 06 Renal Failure, Benign Prostatic Hypertrophy, Infertility, dysmenorrhea, Menopause 5. Disorders of eye: 05 Glaucoma, Cataract, Retinopathy, Conjuctivitis 6. Infectious Diseases 13 General guidelines for the rational use of antibiotics, Meningitis, Respiratory tract infections, Gastroenteritis, Bacterial endocarditis, Septicemia, Otitis media, Urinary tract infections, Tuberculosis, Leprosy, Malaria, Helmenthiasis, HIV and opportunistic infections, Fungal infections, Rheumatic fever.

Recommended study materials: 1. Principles of Pharmacology –The Pathophysiologic Basic – By Golan David E., Lipincott,

Williams and Wilkins publishers.

2. Pharmacological Basis of Therapeutics- By Goodman and Gilman, 10th Edition.

3. Pharmacology-By Rang and Dale, Elsevier Publishers, 6th Edition.

4. Essentials of Pharmacotherapeutics-By F.S. Barar, S. Chand Publishers.

5. Principles of Pharmacology – By Paul L. Munson, A Hodder Arnold Publication.

6. Pharmacology and Pharmacotherapeutics- By R.S.Satoskar, Popular Prakashan.

7. Pharmacotherapy- A Pathophysiological Approach- By Joseph T. Dipiro, McGraw-Hill Medical;

5th & 6th edition.

8. Lewis’s Pharmacology – By James Crossland, Churchil Livingston publisher.

9. Modern Pharmacology with Clinical Applications- By Craig, Charles R, Lippincott Williams &

Wilkins; 6th edition.

10. Principles of Pharmacology- By H. L. Sharma, Paras Medical Publisher.

11. Clinical Pharmacy and Therapeutics – By Roger Walker, Churchil livingstone publication.

12. Clinical Research made easy- A guide to publishing in medical literature – By Mohit Bhandari,

Jaypee Publication.

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HOSPITAL PHARMACY (PH871)

(Theory) Credits 3: Theory Contact hrs per week: 3: Theory 2: Seminar 2: Seminar Objectives of the course: Upon completion of the course student shall be able to

a. Know various drug distribution methods; b. Know the professional practice management skills in hospital pharmacies; c. Provide unbiased drug information to the doctors; d. Know the manufacturing practices of various formulations in hospital set up; e. Appreciate the practice based research methods; and f. Appreciate the stores management and inventory control.

Students learning outcomes/objectives: In Hospital Pharmacy management, the students are required to learn various skills like drug distribution, drug dispensing, manufacturing of parenteral & other preparations, drug information, patient counseling and therapeutic drug monitoring for improved patient care. Outline of the course:

No Unit Minimum No. of Contact Hours

Approx. Weightage %

1 Hospital - Organisation and functions

05 10

2 Hospital pharmacy- Structure, organization and management

06 14

3 The Budget – Preparation and implementation

06 14

4 Hospital drug policy

08 18

5 Hospital pharmacy services

10 20

6 Continuing professional development programs

03 7

7 Radio Pharmaceuticals – Handling and packaging

05 12

8 Professional Relations and practices of hospital pharmacist

02 5

Total 45 100 %

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1 Hospital - its Organisation and functions 05

2 Hospital pharmacy-Organisation and management 06 a) Organizational structure-Staff, Infrastructure & work load statistics b) Management of materials and finance

c) Roles & responsibilities of hospital pharmacist

3 The Budget – Preparation and implementation 06

4 Hospital drug policy 08

a) Pharmacy and Therapeutic committee (PTC) b) Hospital formulary c) Hospital committees - Infection committee - Research and ethical committee d) Developing therapeutic guidelines e) Hospital pharmacy communication - Newsletter

5 Hospital pharmacy services 10

a) Procurement & warehousing of drugs and Pharmaceuticals b) Inventory control

Definition, various methods of Inventory Control ABC, VED, EOQ, Lead time, safety stock

c) Drug distribution in the hospital i) Individual prescription method ii) Floor stock method iii) Unit dose drug distribution method

d) Distribution of Narcotic and other controlled substances e) Central sterile supply services – Role of pharmacist

7 Continuing professional development programs 03

8 Radio Pharmaceuticals – Handling and packaging 05 - Challenges in handling & packaging of radio pharmaceuticals - Legal aspects of Radio pharmaceuticals - Responsibilities & educations regarding Radio pharmaceuticals

9 Professional Relations and practices of hospital pharmacist 02

Project: Hrs/week

Project should be based on hospital pharmacy. 6

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1. Hospital pharmacy by William .E. Hassan

2. A text book of Hospital Pharmacy by S.H.Merchant & Dr. J.S. Qadry. Revised by R.K.Goyal &

R.K. Parikh.

3. WHO consultative group report.

4. R.P.S. Vol.2. Part –B; Pharmacy Practice section.

5. Handbook of pharmacy – health care. Edt. Robin J Harman. The Pharmaceutical press.

6. Advances in Pharmaceutical Sciences – By Bean and Backet, Academic Press Publication.

7. Pharmacy Practice for Technicians – By Den A. Ballington et al., 2nd Edition, New age

Publishers.

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PHARMACOKINETICS (PH883) (Theory)

Credits 3: Theory Contact hrs per week 3: Theory

Objectives of the course:

To Study the absorption, metabolism, distribution and excretion of drugs. The primary goal of the

course related to pharmacokinetics is to provide a conceptual and quantitative background in

pharmacokinetic theory and applications. This will be needed to pursue studies in clinical

pharmacokinetics. The overall study of biopharmaceutics and pharmacokinetics will help in drug

delivery system design and development of pharmaceutical formulations.

Students learning outcomes/objectives:

Students will be able to estimate pharmacokinetic parameters using plasma and urine drug level data.

Students will be able to predict the effects of various physicochemical, biochemical, physiological and

pathological processes on the kinetics and extent of drug absorption, distribution, and elimination.


Through discussion in a class-room, and performing experiments related to Biopharmaceutics &

Pharmacokinetics studies.

Outline of the syllabus:

Sr. No. Unit Minimum

No. of

Contact

Hours

Approx.

Weightage %

1 ADME Characteristics of drug 18 40

2 Pharmacokinetics 14 31

3 Pharmacokinetics of Multiple Dosing 3 7

4 Non-linear Pharmacokinetics 2 4

5 Bioavailability & Bioequivalence 5 11

6 In-vitro In-vivo Correlation (IVIVC) 3 7

Total 45 100%

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1. ADME Characteristics of drug:-

• Drug Absorption: General consideration, absorption / drug transport mechanisms, role of

sorption promoters, factors affecting absorption, absorption of drug of through routes other

than oral, invitro, in-situ, in-vivo and cell line (Caco-2) study methods of determining absorption.

• Drug Distribution: Factors affecting drug distribution, protein & tissue binding, Apparent

volume of drug distribution

• Drug Metabolism (Biotransformation): Biotransformation, factors affecting biotransformation,

Phase I & Phase-II reactions

• Drug Excretion: Glomerular filtration, tubular secretion, tubular reabsorption, Factors affecting

drug excretion.

2. Pharmacokinetics:-

• One compartment and two compartments open model: i.v. bolus administration, i.v. infusion,

extra vascular administration

• Multicompartment model

• Application of Pharmacokinetics: new drug development, Design of dosage forms and novel

drug delivery systems, Case studies based on pharmacokinetic principles

• Determination of various pharmacokinetic parameters

• Absorption rate constant, elimination rate constant, biological half life, % drug metabolized,

apparent volume of distribution, excretion rate constant, Clearance ( including the concept of

renal & non-renal clearance), Kinetics of protein binding and other Pharmacokinetic

parameters

• Softwares used for determination of pharmacokinetic parameters

3. Pharmacokinetics of Multiple Dosing:

Adjustment of dosage in renal & hepatic impairment, individualization of therapy, therapeutic drug

monitoring, Kinetics of sustained release

4. Non-linear Pharmacokinetics: Causes of non-linearity, estimation of various parameters and

bioavailability of drugs that follow non-linear kinetics

5. Bioavailability & Bioequivalence: Objectives of bio-availability & bioequivalence studies,

Measurements of bio-availability, Concept of Bioequivalence, Experimental Designs in Bioequivalence

study (Cross over, Latin Square, Balance incomplete block design etc), Regulatory aspects of bio-

availability and bioequivalence studies for conventional dosage forms and controlled drug delivery

systems

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6 In-vitro In-vivo Correlation (IVIVC):- Concept, Methods of establishing IVIVC, Factors effecting

IVIVC. Application of IVIVC for biowaivers of immediate release dosage forms. IVIVC for Sustain

Release and controlled release dosage forms


1. Pharmacokinetics, M Gibaldi, Marcel Dekker, Inc., New York.

2. Remington’s Pharmaceutical Sciences, Mack publishing company, Pennsylvania.

3. Biopharmaceutics and Pharmacokinetics- A Treatise, D.M. Brahmankar and Sunil B. Jaiswal,

Vallabh Prakashan Pitampura, Delhi.

4. Clinical Pharmacokinetics, Concepts and Applications, M. Rowland and T. N. Tozer,

Lippincott Williams & Wilkins, Philadelphia

5. Biopharmaceutics and Clinical Pharmacokinetics- An introduction; Robert. E. Notari, Marcel

Dekker Inc, New York

6. Encyclopedia of Pharmaceutical Technology, James Swarbrick and C.Boylan, Marcel Dekker

Inc, New York,

7. Pharmaceutical dissolution testing, U.V. Banaker, Marcel Dekker, Inc., New York.

8. The United States Pharmacopoeia-27 (NF-22),2004, United State of Pharmacoppeal convention,

INC, 12601 Twinbrook Parkway, Rockville, MD 20852.

9. Applied Biopharmaceutics and pharmacokinetics, Leon Shargel, Mc Graw Hill,

10. Pharmacokinetics, Welling and Tse, Marcel Dekker, Inc., New York.

11. Biopharmaceutics and Clinical Pharmacokinetics, Niazi, Prentice Hall, London

12. Dose finding in Drug Development, N. Ting, Springer, U.K.

13. Drug disposition & Pharmacokinetics, S.H. Curry, Pharma Med Press , Hyderabad

14. Introduction of Biopharmaceutics & Pharmacokinetics, H. P. Tipnis and M. S. Nagarsenkar,

Nirali Prakashan, Pune.

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BIOSTATISTICS (PH823) (Theory & Practical)

Credits: 2: Theory Contact hrs per week: 2: Theory 2: Practical 4: Practical

Objective of the Course: • To acquaint students with various Statistical Techniques used to draw conclusions in

Experimental Research. • To emphasize the use of these Techniques to address the problems and issues arising in the

discipline of Pharmacy and to find their solutions using Statistical Software. Student Learning Outcomes / objectives:

• Students will able to identify, analyze and solve problems related to biostatistics using statistical software.

Instructional Method and Pedagogy:

• Lectures will be taken in class room with the aid of multi-media presentations / black board or mix of both.

• Assignments based on the course content will be given at the end of the chapter. • Assignment should be submitted to the respective course teacher within the given time limit.

Outline of course:

Sr No. Title of the unit Minimum number of hours Approx. Weightage

% 1. Basics of Probability Distribution 6 20 2. Statistical Computing & Data Management 4 15 3. Principles of Statistical Inference 5 15 4. Analysis of Categorical Data 6 20 5. Linear Models and Experimental Design 4 15 6. Optimization Techniques 5 15

Total 30 100% Detailed Syllabus (Theory):

Sr.No. Contact hrs.1. Basics of Probability Distribution 6 1.1 Probability, random variables, discrete and continuous distributions. 1.2 Sampling Techniques: Simple Random Sampling, Stratified, Systematic

Cluster Sampling and Sampling distributions 1.3 Numerical simulation and graphing with SYSTAT

2. Statistical Computing & Data Management 4 2.1 Data management principles and concepts using relational database software

(Microsoft Access). 2.2 Data manipulation, descriptive analyses and interpretation using statistical

software

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3. Principles of Statistical Inference 5 3.1 Key concepts of estimation, Point Estimates and Interval Estimates,

Construction of Normal-theory confidence intervals 3.2 Theory of estimation including hypothesis tests; methods of inference based

on likelihood theory, including use of Fisher information criteria, Sample size and power

3.3 Wald and score tests; introduction to distribution-free statistical methods.

4 Analysis of Categorical Data 6 4.1 Methods for contingency tables: odds ratios, relative risks, 4.2 Chi-squared tests for independence, Mantel-Haenszel methods for stratified

tables, and methods for paired data.

5 Linear Models and Experimental Design 4 5.1 Method of least squares; regression models and related statistical inference;

multiple regression with matrix algebra; model construction and interpretation.

5.2 One way analysis of variance, planned versus posteriori comparisons, two way analysis of variance, Factorial experiments.

5.3 Response surface design.

6. Optimization Techniques 5 6.1 Optimization using factorial designs 6.2 composite design to estimate curvature 6.3 The simplex lattice

Detailed syllabus (Practicals):

Sr No. Title of the topic 1. Comparison of two independent groups with observations measured on an ordinal,

interval, or ratio scale 2. Comparison of two matched groups with observations measured on an ordinal,

interval, or ratio scale 3. Comparison of two independent groups with observations measured on a

dichotomous scale 4. Comparison of two matched groups with observations measured on a dichotomous

scale

5. Prediction of a continuous response variable from a continuous design variable

6 Measures of association and agreement for observations measured on a nominal, ordinal, interval, or ratio scale

7 Optimization Techniques

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1. Stanford Bolton, Charles Bon (2004), Pharmaceutical Statistics, Practical and Clinical Applications

(Fourth rev. ed) Marcel Dekker, Inc

2. Dowdy, S., and Wearden, S. (1991), Statistics for Research (2nd ed.), New York: John Wiley.

3. Freund, R. J., and Wilson, W. J. (1997), Statistical Methods (rev. ed.), San Diego, CA: Academic Press

4. Miller, R. G., Efron, B., Brown, B. W., and Moses, L. E. (eds.) (1980), Biostatistics Casebook, New York:

John Wiley.

5. Steel, R. G. D., and Torrie, J. H. (1980), Principles and Procedures of Statistics: A Biometrical Approach (2nd

ed.), New York: McGraw-Hill.

6. Woolson, R. F. (1987), Statistical Methods for the Analysis of Biomedical Data, New York: John Wiley.

7. Wackerly DD, Mendenhall W, Scheaffer RL. Mathematical Statistics with Applications, 7th

edition, 2008, Duxbury Press, USA

8. Piantadosi S. Clinical Trials a Methodological Perspective, 2nd edition. John Wiley & Sons 2005

9. Senn S. Cross-over trials in clinical research, 2nd edition. Wiley, 2002.

10. Jennison C. and B.W. Turnbull. Group sequential methods with applications to clinical trials.

Chapman & Hall, 1999.


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RESEARCH METHODOLOGY (PH824) (Theory)

Credits: 4: Theory Contact hrs per week: 4: Theory

Objective of the Course: To make students familiar with various established methods used in pharmaceutical research. Student Learning Outcomes/Objectives: At the end of the course, the student will be able to understand the hierarchy of continue research by proper fundamental methodology. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class room using black board and multimedia projector. Outline of Course:

Sr. No.

Unit Minimum No. of Contact

Hours Approx.

Weightage % 1 Research-Meaning 6 8 2 Literature survey 6 8 3 Selecting a problem and preparing Research

proposals 4 6

4 Methods and tools used in research 6 8 5 Documentation 6 8 6 The Research Report Paper writing/ thesis

writing 15 31

7 Presentation 8 15 8 Cost analysis of the project 4 7 9 Sources for procurement of research grants 2 4 10 Industrial-institution interaction 3 5

Total 60 100 % Detail Syllabus (Theory): 1 Research: 6

Meaning, purpose, Types, (Educational, Clinical, Experimental, historical descriptive, Basic

applied and Patent oriented Research) objective of research.

2 Literature survey: 6

Use of Library, books and journals-Medlines-Internet, Patent Search, and reprints of articles as

a source for Literature survey.

3 Selecting a problem and preparing Research proposals: 4

4 Methods and tools used in research: 6

• Qualitative studies, quantitative studies

• Simple data organization, descriptive data analysis

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• Limitation & sources of Error

• Inquiries in form of Questionnaire, etc.

5 Documentation: 6

“How” of documentation

Techniques of documentation

Importance of documentation

Use of computer packages in documentation.

6 The Research Report writing, Paper writing/ thesis writing: 15

Different parts of the Research paper

• Title , Authors Name & contact details

• Abstract- statement of the problem, background and purpose and scope of

research.

• Key Words

• Subject Area

• Methodology: apparatus, instrumentation & procedure.

• Results- tables, graphs, figures & statistical presentation

• Discussion : support or non support of hypothesis, practical & theoretical

Implications

• Conclusion

• Acknowledgements.

• References

• Errata

• Importance of Spell check for entire research paper & Uses of footnotes

7 Presentation (especially for oral presentation): 8

Importance, types different skills, content, format of model, gestures, eye contact, facial

expressions, stage-fright, volume- pitch, speed, pause & language, Visual aids

& Questionnaire.

8 Cost analysis of the project: 4

Cost incurred on raw materials, different testing procedures for the same

parameter, cost of instrument utilization & cost of the clinical trials.

9 Sources for procurement of research grants: 2

International agencies, Government and private bodies.

10 Industrial-institution interaction: Industrial projects and their feasibility reports 3

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1. Research In Education- John V. Best, John V. Kahn 7th edition, Published by: Phi Learning Pvt.

Ltd.

2. Presentation skills - Michael Hallon- Indian Society for Institute education

3. Practical Introduction to copyright.- Gavin McFarlane, Published By: Mcgraw-Hill Inc, USA.

4. Thesis projects in Science & Engineering – Richard M. Davis. New York: St. Martin’s

Press, 1980.

5. A review of “Scientist in legal Systems”, Journal of Forensic Sciences (JOFS),21(2),1976.

6. Thesis & Assignment – Jonathan Anderson by John Wiley & Sons Inc. USA (1998).

7. Donald Menzel, Jones, Howard Mumford; Boyd, Lyle G., Writing a technical paper, J.

Chem. Edu., 1962, 39 (6), p A500.

8. Effective Business Report Writing –Leland Brown, 2nd Edition, Prentice-Hall,

Englewood Cliffs, New Jersey, 1963.

9. Protection of industrial Property rights- P. Das & Gokul Das.

10. Preparing for publication: A Style Book for Authors, Editors, Compilers and Typists – King

Edward Hospital Fund for London.

11. The Hindu speaks on Information Technology (Special Publication by The Hindu)

12. Manual for evaluation of industrial projects-(Prepared Jointly by United Nations Industrial

Development Organization and the Industrial Development Center for Arab States).

13. Manual for the preparation of industrial feasibility studies (Newly rev. and expanded ed.

W. Behrens, P.M. Hawranek, Published by United Nations Industrial Development

Organization in Vienna. 1991.

14. Relevant articles from journals

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PHARMACOLOGY & PHARMACOTHERAPEUTICS -II (PH866) (Theory)

Credits: 4: Theory Contact hrs per week: 4: Theory 2: Seminar 2: Seminar


To make students familiar with Pharmacological and Pathophysiological basis of drug treatment.


At the end of the course, the student will be able to understand the Pharmacology &

pathophysiological & therapeutical basis of drug treatment.




Sr. No. Unit Minimum No. of Contact Hours

Approx. Weightage %

1 Central Nervous system 20 30

2 Respiratory system 10 20

3 Oncology 25 40

4 Dermatology 5 10

Total 60 100 %


Systemic Pharmacology of given organ-tissue system & important disorders/conditions (Pathology,

etiology, complications, diagnosis, Prognosis), their control and management with special

emphasis on pharmacology of drugs (mechanism of action, ADME, therapeutics use, and adverse

effects, toxicities and possible drug interaction) of the following:

1 Central Nervous system: 20 Parkinson’s disease, Alzheimer’s disease, Behavioral disorders, Epilepsy, Migraine

2 Respiratory system: 10 Bronchial Asthma, Chronic Obstructive Pulmonary Disease (COPD), Allergic Rhinitis, Common cold & Cough, Cystic fibrosis

3 Oncology: 25 Basic principles of Cancer therapy, General introduction to cancer chemotherapeutic

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1. Principles of Pharmacology –The Pathophysiologic Basic – By Golan David E., Lipincott,

Williams and Wilkins publishers.

2. Pharmacological Basis of Therapeutics- By Goodman and Gilman, 10th Edition.

3. Pharmacology-By Rang and Dale, Elsevier Publishers, 6th Edition.

4. Essentials of Pharmacotherapeutics-By F.S. Barar, S. Chand Publishers.

5. Principles of Pharmacology – By Paul L. Munson, A Hodder Arnold Publication.

6. Pharmacology and Pharmacotherapeutics- By R.S.Satoskar, Popular Prakashan.

7. Pharmacotherapy- A Pathophysiological Approach- By Joseph T. Dipiro, McGraw-Hill Medical;

5th & 6th edition.

8. Lewis’s Pharmacology – By James Crossland, Churchil Livingston publisher.

9. Modern Pharmacology with Clinical Applications- By Craig, Charles R, Lippincott Williams &

Wilkins; 6th edition.

10. Principles of Pharmacology- By H. L. Sharma, Paras Medical Publisher.

11. Clinical Pharmacy and Therapeutics – By Roger Walker, Churchil livingstone publication.

12. Clinical Research made easy- A guide to publishing in medical literature – By Mohit Bhandari,

Jaypee Publication.

agents, Chemotherapy of breast cancer, leukemia. Management of chemotherapy nausea, emesis induced by anticancer therapy, Cancer of G.I tract, Lungs, Prostate, Skin, Gynecological.

4 Dermatology: 05 Psoriasis, Scabies, Eczema, Impetigo

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CLINICAL RESEARCH (PH872) (Theory)

Credits: 4: Theory Contact hrs per week: 4: Theory 2: Seminar 2: Seminar Objective of the Course:

To make students familiar with basic principle of clinical pharmacology.


At the end of the course, the student shall be able to understand the principle of clinical

pharmacology.





Approx. Weightage %

1 Clinical trials

8 13

2 Documents in clinical study

8 13

3 Data Management in clinical Research

6 9

4 Ethical guidelines in clinical research

10 18

5 Roles & Responsibility of various clinical trial personnel as per ICH GCP Sponsor, Investigator, Monitor, Auditor

13 18

6 Institution Ethics Committee / Independent Ethics Committee

7 11

7 IND, NDA, ANDA 8 18

Total 60 100%

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Detailed Syllabus (theory):

1 Clinical trials Introduction and designing ,Various phases of clinical trials Post Marketing surveillance – methods, Principles of sampling Inclusion and exclusion criteria ,Methods of allocation and randomization, Informed consent process, Monitoring treatment outcome ,Termination of trial, Safety monitoring in clinical trials

8

2 Documents in clinical study Investigator Brochure (IB), Protocol & Amendment in Protocol ,Case Report Form (CRF), Informed Consent Form (ICF) ,Content of clinical Trial Report Essential Documents in Clinical Trial

8

3 Data Management in clinical Research

6

4 Ethical guidelines in clinical research History ICH-GCP & its Principles Indian GCP (CDSCO Guidelines) ICMR Guidelines - Ethical Guidelines for Biomedical Research on Human Subjects Schedule Y

FDA guidelines for clinical trials, reviews and approval of a clinical study.

10

5 Roles & Responsibility of various clinical trial personnel as per ICH-GCP Sponsor, Investigator, Monitor, Auditors

13

6 Institutional Ethics Committee (IEC) / Independent Ethics Committee (IdEC):

7

7 Role of Quality Assurance in clinical Research & Clinical research application in India, around the world & NDA, IND, ANDA.

8


1. Rick NG. Drugs From Discovery To Approval. John Wiley & Sons, Inc 2004.

2. Allen Cato, Lynda Sutton Clinical Drug Trials and Tribulations Second Edition Revised and

Expanded. Marcel Dekker, Inc. 2002.

3. Deborah Rosenbaum, Michelle Dresser. Clinical Research Coordinator HandbookSecond

Edition Practical Clinical Trials Series GCP Tools and Techniques Interpharm/CRC New York

Washington, D.C. 2002.

4. Tamas Bartfai, Graham V. Lees. Drug Discovery from Bedside to Wall Street. Elsevier Academic

Press. London 2006.

5. Ronald D. Mann, Elizabeth B. Andrews. Pharmacovigilance. John Wiley & Sons Ltd,

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2002.

6. Shayne C. Gad. Drug Safety Evaluation. A John Wiley & Sons, Inc., Publication

7. Bert Spilker. Guide to Clinical Trials.

8. Sandy Weinberg. Guidebook For Drug Regulatory Submissions. A John Wiley & Sons, inc.

2009.

9. Duolao Wang and Ameet Bakhai Clinical Trials A Practical Guide to Design,

Analysis, and Reporting. Remedica 2006

10. Textbook of Clinical Trial edited by David Machin, Simon Day and Sylvan Green, March 2005,

John Wiley and Sons.

11. Principals of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.

12. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition,

2000, Wiley Publications.

13. Various Guidelines like:

- ICH, GCP- International Conference on Harmonisation of Technical requirements

for registration of pharmaceuticals for human use. ICH Harmonised Tripartite

Guideline. Guideline for Good Clinical Practice, E6 1996.

- ICMR Guideline – Ethical Guidelines for Biomedical Research on Human Subjects.

- Indian GCP – Central Drugs Standard Control Organization. Good Clinical Practices

- Guidelines for Clinical Trials on Pharmacuetical Products in India. New Delhi: Ministry of

Health; 2001.

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PHARMACY PRACTICE (PH873) (Theory)

Credits: 2: Theory Contact hrs per week: 2: Theory Objectives of course: Upon completion of the course, the student shall be able to – a. Know pharmaceutical care services; b. Know the business and professional practice management skills in community pharmacies; c. Perform patient counseling & provide health screening services to public in community Pharmacy; d. Respond to minor ailments and provide appropriate medication e. Show empathy and sympathy to patients and appreciate the concept of Rational drug therapy Student Learning Outcomes/Objectives:

At the end of the course, the student will be able to understand the principles of pharmacy practice, community pharmacy, Pharmacovigilance & Pharmacoeconomics Instructional Methods and Pedagogy:


Outline of course:


Approx. Weightage %

1 Definitions, Development & scope of pharmacy practice

03 5

2 Introduction to duties of a clinical pharmacist

15 25

3 Patient data analysis 04 5

4 Community Pharmacy Management & its Ethics

10 20

5 Drug & Poison information 12 20

6 Pharmacovigilance 6 10

7 Pharmacoeconomics 6 10

8 Medication errors 4 5

Total 60 100 %

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Detail Syllabus (theory):

3. Patient data analysis 04

The patient's case history, its structure and use in evaluation of drug therapy &

Understanding common medical abbreviations and terminologies used in clinical

practices.

4 Community Pharmacy Management & its Ethics 10

a) Role & Responsibility of community pharmacist

- Selection of site, Space layout and design

b) Staff, Materials- coding, stocking

c) Legal requirements

d) Maintenance of various records/registers

e) Use of Computers: Business and health care soft wares

f) Code of ethics of community pharmacist

5. Drug & Poison information 12

a. Introduction to drug information resources available

b. Systematic approach in answering Drug Information queries

c. Critical evaluation of drug information and literature

d. Preparation of written and verbal reports

e. Establishing a Drug Information Centre

f. Poisons information- organization & information resources

6. Pharmacovigilance 06

a. Scope, definition and aims of pharmacovigilance

b. Adverse drug reactions - Classification, mechanism, predisposing factors, causality

assessment [different scales used]

c. Reporting, evaluation, monitoring, preventing & management of ADRs

d. Role of pharmacist in management of ADR.

1. Definitions, Development & scope of pharmacy practice 03

2. Introduction to duties & activities of a clinical pharmacist 15

a. Drug therapy monitoring (medication chart review, clinical review, pharmacist

interventions)

b. Ward round participation

c. Adverse drug reaction monitoring & management

d. Drug information and poisons information

e. Medication history

f. Patient counseling &Communication skills,

g. Drug utilization evaluation (DUE) and review (DUR)

h. Quality assurance of clinical pharmacy services

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7. Pharmacoeconomics 06

Definition, history, needs of pharmacoeconomic evaluations, Outcome assessment and

types of phamacoeconomic evaluations: cost-minimization

8. Medication errors 04

Hrs/Week

Project: Project should be based on Hospital / pharmacy practice. 6


1. Ronald D. Mann, Elizabeth B. Andrews. Pharmacovigilance. John Wiley & Sons Ltd, 2002.

2. Text Book of Therapeutics: Drug and Disease Management. 7th Edition. Editors: Eric T.

Herfindal and Dick R. Gourley, Williams and Wilkins

3. Clinical Pharmacy and Therapeutics. Roger Walker and Clive Edwards, Churchill Livingstone

publication

4. Applied Therapeutics: The Clinical Use or Drugs Eds. Brian S.Katcher, Lioyd Yee Young, Marry

Anne Koda-Kimble, Applied Therapeutics Inc. Spokane. Latest Edition.

5. Practice Standards and Definitions – The Society of Hospital Pharmacists of Australia.

6. Basic Skills in interpreting laboratory data – Scott LT, American Society of Health System

Pharmacists Inc.

7. Biopharmaceutics and Applied Pharmacokinetics – Leon Shargel, Prentice Hall Publication.

8. A textbook of Clinical Pharmacy Practice; Essential concepts and skills, Dr. G. Parthasarthi et al.

9. Australian drug information- Procedure manual. The Society of Hospital Pharmacists of

Australia.

10. Textbook of Medical laboratory Technology. Praful B. Godkar, Darshan P.Godkar, Bhalani

Publication House, Mumbai. 2nd edition.

11. Clinical Pharmacokinetics- Rowland Tozer, Williams and Wilkins Publication.

12. Pharmaceutical Statistics. Practical and clinical applications. Sanford Bolton, Marcel Dekker

Inc.

13. Drug Interaction Facts, 2003. David S. Tatro.

14. Hand Book of Pharmacy Health Care. The Pharmaceutical Press

15. Manual of basis techniques for a health laboratory, 2nd edition, World Health Organization,

Geneva.

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DRUG REGULATORY AFFAIRS & INTELLECTUAL PROPERTY RIGHTS (PH921)

(Theory)

Credits: 4: Theory Contact hrs per week: 4 Theory

Objectives of the course:

- To explore the regulatory provisions with respect to clinical trials, Investigational New Drug

Application, New Drug Application, ANDA, market authorization of medicines, inspection of

Pharmaceutical manufactures and product registration.

- To explore practical aspects repeated to patenting

Students learning outcomes/objectives:

- To get familiar with regulatory aspects related to Research & Development as well as

manufacturing and marketing of Pharmaceutical Products

- To get familiar with ICH guidelines with reference to Quality topics.


- The course employs lectures and class discussions. It also includes presentation by students on

a specific topic assigned to them by the faculty

Outline of the course:

No. Unit Minimum no. of Contact Hours.

Aprrox. Weightage %

Part – I: Drug Regulatory Affairs

1 Regulatory aspects related to clinical trials as per Schedule Y of Drugs and Cosmetics Act 1940 and rules.

5 8

2 Regulatory aspects related to filing of IND, NDA,ANDA

5 8

3 ICH Guidelines: Quality topics 7 12

4 SUPAC guidelines for Immediate release solid oral dosage form

5 8

5 MHRA guideline for Market authorization of medicines 4 7

6 WHO guidelines for inspection of pharmaceutical Manufacturers.

5 8

7 Requirements of product registration in India 4 7

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Part – II: Intellectual Property Rights (IPR)

8 Intellectual Property Concepts 5 8

9 IPR and Pharmaceutical Research 5 8

10 Practical aspect of patenting 6 11

11 IPR related treaties 4 7

12 Case Study 5 8

Total 60 100%


1. Regulatory aspects related to clinical trials as per Schedule Y of Drugs and Cosmetics Act 1940

and rules. 5

2. Regulatory aspects related to filing of 5

• Investigation New Drug (IND) Application

• New Drug Application (NDA)

• Abbreviated New Drug Application (ANDA)

3. ICH Guidelines: Quality topics 7

• Q7: Good manufacturing practices for Active Pharmaceutical Ingredients

• Q8: Pharmaceutical Development

• Q9: Quality Risk Management

• Q10: Pharmaceutical Quality System

4. SUPAC guidelines for Immediate release solid oral dosage form 5

5. MHRA guideline for Market authorization of medicines. 4

6. WHO guidelines for inspection of pharmaceutical Manufacturers. 5

7. Requirements of product registration in India. 4

8. Intellectual Property Concepts: 5

• Concept of property, conventional property Vs Intellectual Property

• Basic aspect of the 8 different IPR mechanism Viz. Patents, Copyright, trademark,

industrial design, layout design of integrated circuits, geographical indicators, plant

varieties & trade secrets.

9. IPR and Pharmaceutical Research: 5

• Benefits of IPRs to improve the quality of research work

• Strategies for avoiding research duplications, infringements

10. Practical aspect of patenting: 6

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• Indian patent act and its recent amendment with respect to following aspect

o Patentable and non-patentable inventions.

o Essential criteria for filing a patent.

o Filling a patent in India and abroad

o Drafting of patent application

• Patenting: Regional routes & national routes.

• Introduction to World Intellectual Property Organization. (WIPO)

• Commercialization of patent: Need for Commercialization of research and role of IPRs in

research Commercialization.

• Benefit/Disadvantages of patenting to the society

11. IPR related treaties: 4

1. Patent co-operative treaty

2. Budapest treaty

12. Case Study 5

Recommended Study materials:

1. www.mohfw.nic.in

2. www.usfda.gov

3. www.mhra.gov.uk

4. www.ich.org/cache/compo/363-272-1.html

5. apps.who.int/prequal/info_general/documents/TRS823/WHO_TRS_823-Annex2.pdf

6. FDA regulatory Affairs, edited by D. J. Pisano and D. Mantus, CRS Press, Boca Rocan,Florida.

7. New Drug Approval process, 4th Edition, R.A.Guarino, Marcel Dekker, New York.

8. IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pharma Book

Syndicate, Hyderabad.

9. Patents, N. R. Subbaram, Pharma Book Syndicate, Hyderabad.


11. www.pat2pdf.org

12. www.patentstorm.us

13. www.freepatentsonline.com

14. http://www.wipo.int/pctdb/en/

15. www.espacenet.com

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