M.Pharm.(Clinical Pharmacy)

Page 1 of 47

ACADEMIC

REGULATIONS

&

SYLLABUS

Faculty of Pharmacy

Master of Pharmacy Programme (Clinical Pharmacy)

From Academic Year–2013-14

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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 32 different

programmes. A quick glimpse in as under:

Faculty Institute Programmes

Offered

Faculty of Technology & Engineering Chandubhai S. Patel 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

PGDM

Ph.D Faculty of Computer Applications Smt. Chandaben Mohanbhai Patel

Institute of Computer Applications M.C.A.

M.Sc.(IT)

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

Manikaka Topawala Institute of Nursing

B.PT

B.Sc (Nursing)

G.N.M.

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The development and growth of the institutes have already led to an investment of over Rs.80 crores

(INR 800 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 105 acres of land and is Wi-Fi

enabled. It is also recognized as the Greenest Campus of Gujarat.

CHARUSAT is privileged to have 350 core faculty members, educated and trained in 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:

• 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.

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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 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

From Academic Year–2013-14

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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 Contact Hours/Week Credits

Code Name Theory

Seminar Practical Total Theory

+Seminar Practical Total

PH812.01 Analytical Techniques 4 -- -- 4 4 - 4

PH813.01 Clinical Pharmacy Practice 4 1 -- 5 5 -- 5 PH813.02 Pharmacotherapeutics -I 4 1 -- 5 5 -- 5

PH813.03 Advance Pharmacokinetics & Clinical Applications

4 -- -- 4 4 -- 4

PH813.04 Clinical Pharmacy Practical-I -- -- 6 6 -- 3 3

PH812.06 Practical-II (Analytical Techniques) -- -- 6 6 -- 3 3

PH824.01 Scientific Communication -- -- 3 3 -- 1 1

PH824.02 Community Services-I -- -- 3 3 -- 1 1

Total 16 2 18 36 18 8 26 Total Credits of 1st semester: 26

Course Theory Practical

Code Name University

Institute

Total University Institute Total Test Seminar

PH812.01 Analytical Techniques 70 30 -- 100 -- -- -- PH813.01 Clinical Pharmacy Practice 70 20 10 100 -- --- --

PH813.02 Pharmacotherapeutics -I 70 20 10 100 -- -- --

PH813.03 Advance Pharmacokinetics & Clinical Applications 70 30 -- 100 -- -- --

PH813.04 Clinical Pharmacy Practical-I -- -- -- -- 70 30 100

PH812.06 Practical-II (Analytical Techniques) -- -- -- -- 70 30 100

PH824.01 Scientific Communication -- -- -- -- -- 50 50 PH824.02 Community Services-I -- -- -- -- -- 50 50

Total 280 100 20 400 140 60 200

Total marks of 1st semester: 700

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CHAROTAR UNIVERSITY OF SCIENCE & TECHNOLOGY

M. Pharm. (Clinical Pharmacy) SEMESTER-2

Scheme of Teaching



Code Name Theory Seminar Practical Project Total Seminar+

Theory Practical Project Total

PH824.03 Research methodology & IPR

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

PH813.05 Pharmacotherapeutics -II

4 1 -- -- 5 5 -- -- 5

PH812.07 Clinical Research 4 1 -- -- 5 5 -- -- 5

PH813.06 Advance Hospital pharmacy Management

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

PH813.07 Clinical Pharmacy Practical-III

-- -- 6 -- 6

-- 3 -- 3

PH813.08 Clinical Pharmacy Practical-IV

-- -- 6 -- 6 -- 3 -- 3

PH813.09 Dissertation- Part-I -- -- -- 3 3 -- -- 3 3

PH824.04 Community services- II

-- -- 3 -- 3 -- 1 -- 1

Total 16 2 15 3 36 18 7 3 28

Total Credits of 2nd semester: 28

Course Theory Practical

Code Name University Institute

Total University Institute Total Theory Seminar

PH824.03 Research methodology & IPR

70 30 -- 100 -- -- --

PH813.05 Pharmacotherapeutics -II

70 20 10 100 -- -- --

PH812.07 Clinical Research 70 20 10 100 -- -- --

PH813.06 Advance Hospital pharmacy Management

70 30 -- 100 -- -- --

PH813.07 Practical-III -- -- -- -- 70 30 100

PH813.08 Practical-IV -- -- -- -- 70 30 100

PH813.09 Dissertation- Part-I -- -- -- -- -- 50 50

PH824.04 Community services- II

-- -- -- -- -- 50 50

Total 280 100 20 400 140 160 300

Total marks of 2nd semester: 700

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M. PHARM (Clinical Pharmacy)

Semester-3

Scheme of teaching


Sr. No. Name Theory Practical Project Total Theory Practical Project Total

PH913.01 Dissertation Part-II -- -- 36 36 -- -- 25 25

Total -- -- 36 36 -- -- 25 25

Total credits: 25


Course

Theory Practical Project

University Institute Total University Institute Total University Institute Total

Sr. No. Name

PH913.01 Dissertation Part-II -- -- -- -- -- -- 150 100 250

Total -- -- -- -- -- -- 150 100 250

Total marks of 3rd semester : 250

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M. PHARM (Clinical Pharmacy)

Semester-4

Scheme of teaching

Part I: 10 weeks


Sr. No. Name Theory Practical Project Total Theory Practical Project Total

PH913.02 Dissertation Part-III -- -- 36 36 -- -- 25 25

Part II: 5 Weeks

PH913.03 Industrial Training -- -- -- -- -- -- 2 2

Total -- -- -- -- -- -- 27 27

Total Credit :28


Course

Theory Practical Project

University Institute Total University Institute Total University Institute Total

Sr. No. Name

PH913.02 Dissertation

Part-III -- -- -- -- -- -- 150 100 250

PH913.03 Industrial

Training -- -- -- -- -- -- -- 50 50

Total -- -- -- -- -- -- 150 150 300

Total Marks of 4th Semester : 300

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SYLLABI (Semester – 1)


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SEMESTER-I ANALYTICAL TECHNIQUES (PH812.01)

_____________________________________________________________________________________

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

_________________________ Objective of the Course: To make students familiar with the principles of modern analytical techniques and its 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.

Minimum No.

of Contact Hours

Approx.

Weightage %

Unit I 30 50

1 Spectroscopic techniques 15 25

2 Chromatographic techniques 15 25

Unit II 30 50

1 Electrophoresis: 8 13

2 Antibody Related Techniques 6 10

3 Imaging techniques 10 17

4

Fluorescence/

phosphorescence/chemiluminescence

Spectroscopy

6 10

Total 60 100

Detailed Syllabus (Theory):

No. Unit Details Hrs.

Unit I

1. Spectroscopic techniques: Introduction, basic principle, instrumentation (components

and their function), sampling techniques, interpretation of spectra and applications of

following Spectroscopic techniques; UV – Visible spectroscopy, Infrared spectroscopy,

15

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Nuclear Magnetic Resonance Spectroscopy and Mass Spectroscopy.

2. 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.

15

UNIT II

1 Fluorescence/ phosphorescence/chemiluminescence Spectroscopy fluorescence, phosphorescence, chemiluminescence, emission and excitation spectra, fluorimeters, spectrofluorimeters, qualitative and quantitative applications.

6

2 Electrophoresis: Theory and principles, classifications, instrumentation, moving boundary electrophoresis, Zone Electrophoresis (ZE), Capillary Electrophoresis, Isoelectric focusing (IEF), and applications.

8

3 Antibody Related Techniques Importance of Radioisotopes in medicine, Instrumentation and analysis methods ,Immuno assays RIA, ELISA, blotting techniques

6

4 Imaging techniques Principle of Immunofluorescence Microscopy Staining techniques for live cell imaging and fixed cells Flow cytometry, Instrumentation, Applications; Cell Functional Assays – lymphoproliferation, Cell Cytotoxicity, mixed lymphocyte reaction, Apoptosis, Cytokineexpression; In–situ gene expression techniques; Cell imaging Techniques- Invitro and In vivo; Immuno-electron microscopy; In vivo cell tracking techniques; Microarrays

10

Recommended Study material

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.

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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 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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SEMESTER-1

Clinical Pharmacy Practice(PH813.01) Credits: 4: Theory Contact hrs per week: 4: Theory 1: Seminar 1: Seminar 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: Faculty member/s shall explain in a class roomusing black board and multimedia projector.

Outline of course:

Sr. No.

Unit Minimum No. of Contact Hours

Approx. Weightage %

1 Definitions, development and scope of clinical pharmacy

03 5%

2 Introduction to daily activities of a clinical pharmacist

10 17%

3 Patient data analysis 04 6% 4 Clinical laboratory tests used in the

evaluation of disease states, and interpretation of test results

09 15%

5 Drug & Poison information 14 23% 6 Pharmacovigilance 06 10% 7 Pharmacoeconomics 06 10% 8 Medication errors 03 5% 9 Introduction to national health

Program 05 9%

Total 60 100

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Detailed Syllabus

1. Definitions, development and scope of clinical pharmacy

03

2. Introduction to daily activities of a clinical pharmacist a. Drug therapy monitoring (medication chart review, clinical review, pharmacist

interventions)

b. Ward round participation

c. Adverse drug reaction management

d. Drug information and poisons information

e. Medication history

f. Patient counseling &Communication skills,

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

h. Quality assurance of clinical pharmacy services

10

3 Patient data analysis The patient's case history, its structure and use in evaluation of drug therapy & Understanding common medical abbreviations and terminologies used in clinical practices.

04

4 Clinical laboratory tests used in the evaluation of disease states, and interpretation of test results a. Haematological, Liver function, Renal function, thyroid function tests

b. Tests associated with cardiac disorders

c. Fluid and electrolyte balance

d. Microbiological culture sensitivity tests

e. Pulmonary Function Tests

09

5 Drug & Poison information 14

a. Introduction to drug information resources available b. Systematic approach in answering DI 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 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.

06

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7 Pharmacoeconomics Definition, history, needs of pharmacoeconomic evaluations Outcome assessment and types of phamacoeconomic evaluations: cost-minimization

06

8 Medication errors 03

9 Introduction to national health Program 05

Recommended books:

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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SEMESTER-1

Pharmacotherapeutics -I (PH813.02)

Credits: 4: Theory Contact hrs per week: 4: Theory 1: Seminar 1: Seminar Objective of the Course: To make students familiar with Pharmacological and Pathophysiological basis of drug treatment. Student Learning Outcomes/Objectives: At the end of the course, the student willbe able to understand the Pharmacology & pathophysiological & therapeuticalbasis of drug treatment. Instructional Methods and Pedagogy: Faculty member/s shall explain in a class roomusing black board and multimedia projector.

Outline of course:

Sr. No.


Approx. Weightage %

1 Cardiovascular and Hemopoietic system

25 41%

2 Endocrine system 12 20% 3 Gastro-intestinal System 08 14% 4 Urogenital system 06 1% 5 Disorders of eye 03 5% 6 Gout and Rheumatoid Arthritis 06 10% Total 60 100

Detailed Syllabus

Theory:

Important disorders/conditions (etiology, complications, diagnosis,Pathophysiology Prognosis), their control and management with special emphasis on pharmacotherapeutics of the following: 1. . Cardiovascular and Hemopoietic system; 25 Hypertension, Acute Coronary Syndrome, Angina Pectoris, Atherosclerosis, Congestive Heart Failure, Arrhythmias, Thromboembolic disorder, Anaemia 2. Endocrine system: 12 Disorders of thyroid gland and Parathyroid gland, Diabetes, Adrenocortical dysfunction 3. Gastro-intestinal System: 08 Peptic Ulcer, Inflammatory Bowel Disease, Liver diseases

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4. Urogenital system: 06 Renal Failure, Benign Prostatic Hypertrophy, dysmenorrhea, Menopause 5. Disorders of eye: 03 Glaucoma 6. Gout and Rheumatoid Arthritis 06

Recommended books:

1. Principles of Pharmacology –The Pathophysiologic Basic –Golan David E. 2. Pharmacological Basis of Therapeutics-Goodman and Gilman 3. Pharmacology-Rang and Dale 4. Essentials of Pharmacotherapeutics-F.S. Barar 5. Principles of Pharmacology – Paul L. Munson 6. Pharmacology and Pharmacotherapeutics-R.S.Satoskar 7. Pharmacotherapy- A Pathophysiological Approach-Joseph T. Dipiro. 8. Lewis’s Pharmacology – James Crossland – Churchil Livingston 9. Modern Pharmacology with Clinical Applications- Craig, Charles R. 10. Principles of Pharmacology--H. L. Sharma 11. Textbook of Therapeutics: Drug and Disease Management- Eric T. Herfindal, D. R. H. Gourley

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SEMESTER-1

Advance Pharmacokinetics & Clinical Applications (PH813.03) Credits: 4: Theory Contact hrs per week: 4: Theory Objectives of the course: The primary goal of the course related to pharmacokinetics is to provide a conceptual and quantitative background in clinical pharmacokinetic theory and applications. This should be helpful in studying clinical prospectives of pharmacokinetic applications. 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. Instructional Methods and Pedagogy: Through discussion on case studies in a class-room, and performing group exercise related to Clinical Pharmacokinetics studies.


Sr. No.


Approx. Weightage %

1 Introduction to Clinical pharmacokinetics.

03 5%

2 Design of dosage regimens 12 20% 3 Pharmacokinetics of Drug Interaction 08 14% 4 Therapeutic Drug monitoring 10 15% 5 Dosage adjustment in Renal and

hepatic Disease 10 16%

6 Pharmacogenetics 10 15% 7 Bioavailability & Bioequivalence 07 13% Total 60 100

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Detailed Syllabus

Theory:

1. Introduction to Clinical pharmacokinetics. 03 2. Design of dosage regimens: 12 Tabulations in designing dosage regimen, Conversion from intravenous to oral dosing, Determination of dose and dosing intervals, Drug dosing in the elderly and pediatrics and Pregnancy & Lactation. 3. Pharmacokinetics of Drug Interaction: 08 a. Pharmacokinetic drug interactions

b. Inhibition and Induction of Drug metabolism c. Inhibition of Biliary Excretion.

4. Therapeutic Drug monitoring: 10 a. Introduction

b. Individualization of drug dosage regimen (Variability – Genetic, Age and Weight , disease, Interacting drugs).

c. Indications for TDM. Protocol for TDM. d. Pharmacokinetic/Pharmacodynamic Correlation in drug therapy. e. TDM of drugs used in the following disease conditions: cardiovascular disease,

Seizure disorders, Psychiatric conditions, and Organ transplantations.

5. Dosage adjustment in Renal and hepatic Disease. 10 a. Renal impairment

b. Pharmacokinetic considerations c. General approach for dosage adjustment in Renal disease. d. Measurement of Glomerular Filtration rate and creatinine clearance. e. Dosage adjustment for uremic patients. f. Extracorporeal removal of drugs. g. Effect of Hepatic disease on pharmacokinetics.

6. Pharmacogenetics 10 Historical aspects of pharmacogenetics, biomarkers, inter-racial and individual variability in drugs metabolism., receptors .Role of drug transporters, interethnic differences, clinical view points and future perspectives, stem cell – a new therapeutic approach. Gene therapy, Pharmacovigilance concepts and its impact.

7. Bioavailability & Bioequivalence: 07 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.

Page 26 of 47

Recommended books: 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. 15. Textbook of Biopharmaceutics & Pharmacokinetics, Javed Ali, R. K. Khar and Alka Ahuja, Birla Publication, Delhi.

Page 27 of 47

SEMESTER-I CLINICAL PHARMACY PRACTICAL-I (PH813.04)

__________________________________________________________________________

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

___________________________________________________________________________________________

Objective of the Course:

To make students familiar with Clinical Pharmacy Practice

Student Learning Outcomes/Objectives:

At the end of the course, the student will be able to learn the basic roles and responsibility of

clinical pharmacist and able to understand role in patient safety.

Instructional Methods and Pedagogy:

Faculty member/s shall explain hospital based cases or any hypothetical cases in a group of

students with discussion using black board and multimedia projector.

Practicals:

Part –I: Hospital training

Part- II: Illustrative practicals based on theory syllabus of Clinical Pharmacy Practice and diseases/condition covered in Pharmacotherapeutics-I.

Page 28 of 47

SEMESTER-I PRACTICAL-II(ANALYTICAL TECHNIQUES) (PH812.06)

___________________________________________________________________________

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

____________________________________________________________________________________________

To illustrate the topics included under theory of Analytical Techniques.

Page 29 of 47

SEMESTER-I Scientific Communication (PH824.01)

(Practical) Credits: 1 (Practical) Contact Hours per week: 3 (Practical)


To enhance the scientific communication skills of students

Student Learning Outcomes / Objectives:

The students are expected to strengthen their communication skills in scientific writing as well

presentations.


The faculty shall stress on the importance of the concept of the specific type of module of

communication and explain using examples. The students may be assigned individual exercise

and they will be counseled personally, keeping in mind the aspects of plagiarism.

Outline of the Course (Practical):

No. Unit Practical hours per

week 1. Development of Scientific Writing Skills

3 .00 2. Development of Presentation Skills

Total 45 hours/

semester

Page 30 of 47

Detailed syllabus (Practical):

No. Unit Scientific Writing Skills

1 Review of Instruction for Authors of a Journal / Periodical - I

2 Report writing for publication in various formats

3 Preparation of Manuscript for publication to a Journal / Periodical - I

4 Writing in Laboratory Notebook on Experiment Carried Out

5 So P Preparation

Comprehension of Scientific writing

6 Review and Analysis of Review / Research Article - I

7 Review and Analysis of Review / Research Article - II

Presentation of Scientific Matter

8 Poster Presentation

9 Oral (Podium) Presentation - I

10 Oral (Podium) Presentation - II

11 Verification of plagiarism using softwares

Page 31 of 47

SEMESTER-I

COMMUNITY SERVICES-I (PH824.02)

(PRACTICAL)

Credits: 1 Contact hrs per week: 3

Course Description

• Students are undertaking a group research project. Students of each group choosing community service projects must commit at least 3 hours/week to their projects.

• Students in this course will have an opportunity to work collaboratively with community partners to identify needs in communities.

• Students will investigate, discuss, and plan methods of addressing identified needs within the community.

• Under the guidance of the instructor or an advisor, students will be actively involved in implementing a self-designed community service project.

Course Goals

• Promote active learning and responsible citizenship.

• Identify personal values, beliefs, attitudes, and philosophies.

• Promote collaborative learning.

• Strengthen ties between student and community; and community and college.

• Foster a commitment of service to others. Course Objectives

• Develop interpersonal skills necessary for being an active participant in a community

• Develop a learning community

• Investigate and identify needs within a community

• Develop a plan of action for responding to an identified need of the community Course Evaluation

Students choosing to do projects are expected to demonstrate that they have expended at 45

hours on their projects.

The performance of every student will be evaluated as follows: Approx. Weightage (%) Project Proposal 50 Midterm & Final report (assignment) 50

Page 32 of 47


SYLLABI (Semester – 2)


Page 33 of 47

SEMESTER II RESEARCH METHODOLOGY & IPR (824.03)

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.

• To explore practical aspects related to patenting. 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.

• To get familiar with IPR and Patents.


• Faculty member/s shall explain and discuss the case studies in a class room using black board and multimedia projector.


Sr. No.


Approx. Weightage %

Part-I Research Methodology

1 Research 3 5

2 Research problem formulation 5 8

3 Methods and tools used in research 4 7

4 Documentation 4 7

5 The Research Report writing, Paper writing/ thesis writing

8 15

6 Presentation 4 7

7 Cost analysis of the project 3 4

8 Sources for procurement of research grants 4 7

Part – II : Intellectual Property Rights (IPR)

1 Intellectual Property Concepts 5 7

2 IPR and Pharmaceutical Research 4 7

3 Practical aspect of patenting 9 14

4 IPR related treaties 3 5

5 Case Study 4 7

Total 60 100%

Page 34 of 47

Detailed Syllabus: Part-I Research Methodology (35 hours)

1 Research: Meaning, purpose, Types, (Educational, Clinical, Experimental, historical descriptive, Basic applied and Patent oriented Research) objective of research.

2 Research Problem Formulation: Literature Survey: purpose and use of literature review, locating relevant information, use of library and e-resources like Science Direct, Informa Health, Begell House, ACS Publications, Taylor and Francis, Springer, American Chemical Society etc. Preparation and presentation of literature review, research and review articles, theoretical models and framework, selecting problem and preparing research proposal.

3 Methods and tools used in research:

• Qualitative studies, quantitative studies

• Simple data organization, descriptive data analysis

• Limitation & sources of Error

• Inquiries in form of Questionnaire, etc.

• Role of Quality by Design (QbD) in Pharmaceutical Research

4 Documentation:

• “How” of documentation

• Techniques of documentation

• Importance of documentation

• Use of computer packages in documentation. 5 The Research Report writing, Paper writing/ thesis writing: 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

Page 35 of 47

6 Presentation (especially for oral presentation): Importance, types different skills, content, format of model, gestures, eye contact, facial expressions, stage-fright, volume- pitch, speed, pause & language, Visual aids & Questionnaire.

7 Cost analysis of the project: Cost incurred on raw materials, different testing procedures for the same parameter, cost of instrument utilization & cost of the clinical trials.

8 Sources for procurement of research grants: International agencies, Government and private bodies, Industrial projects and their feasibility reports

Part-II IPR (25 Hours) 1. Intellectual Property Concepts:

• 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.

2. IPR and Pharmaceutical Research:

Benefits of IPRs to improve the quality of research work Strategies for avoiding research duplications, infringements

3. Practical aspect of patenting: Indian patent act and its recent amendment with respect to following aspect

Patentable and non-patentable inventions. Essential criteria for filing a patent. Filling a patent in India and abroad

Drafting of patent application Patenting: Regional routes & national routes. Introduction to World Intellectual Property Organization. (WIPO) GAAT and IPR Commercialization of patent: Need for Commercialization of research and role of IPRs in

research Commercialization. Benefit/Disadvantages of patenting to the society

4. IPR related treaties: 1. Patent co-operative treaty 2. Budapest treaty

5. Case Study Recommended Study materials: 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

Page 36 of 47

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. Stanford Bolton, Charles Bon (2004), Pharmaceutical Statistics, Practical and Clinical Applications (Fourth rev. ed) Marcel Dekker, Inc

15. Relevant articles from journals 16. IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pharma Book

Syndicate, Hyderabad. 17. Patents, N. R. Subbaram, Pharma Book Syndicate, Hyderabad. 18. Relevant articles from journals. 19. www.pat2pdf.org 20. www.patentstorm.us 21. www.freepatentsonline.com 22. http://www.wipo.int/pctdb/en/ 23. www.espacenet.com

Page 37 of 47

SEMESTER II

Pharmacotherapeutics –II (PH813.05) Credits: 4: Theory Contact hrs per week: 4: Theory 1: Seminar 1: Seminar


To make students familiar with Pharmacological and Pathophysiological basis of drug treatment. Student Learning Outcomes/Objectives: At the end of the course, the student will be able to understand the Pharmacology & Pathophysiological & therapeuticalbasis of drug treatment. Instructional Methods and Pedagogy: The faculty member/s shall explain in a class room using black board and a multimedia projector.

Outline of course:

Sr. No.


Approx. Weightage %

1 Central Nervous system 20 38% 2 Respiratory system 10 15% 3 Oncology 25 42% 4 Evidence Based Medicine 5 5% Total 60 100

Detailed Syllabus

Theory: 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 agents, Chemotherapy of breast cancer, leukemia. Management of chemotherapy 4. Evidence Based Medicine 05

Page 38 of 47

Books Recommended:

1. Principles of Pharmacology –The Pathophysiologic Basic –Golan David E. 2. Pharmacological Basis of Therapeutics-Goodman and Gilman 3. Pharmacology-Rang and Dale 4. Essentials of Pharmacotherapeutics-F.S. Barar 5. Principles of Pharmacology – Paul L. Munson 6. Pharmacology and Pharmacotherapeutics-R.S.Satoskar 7. Pharmacotherapy- A Pathophysiological Approach-Joseph T. Dipiro. 8. Lewis’s Pharmacology – James Crossland – Churchil Livingston 9. Modern Pharmacology with Clinical Applications- Craig, Charles R. 10. Principles of Pharmacology--H. L. Sharma 11. Textbook of Therapeutics: Drug and Disease Management- Eric T. Herfindal, D. R. H. Gourley

Page 39 of 47

SEMESTER II

Clinical Research (PH812.07) Credits: 4: Theory Contact hrs per week: 4: Theory 1: Seminar 1: Seminar


To make students familiar with basic principle of clinical Research and new drug development in human.


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

pharmacology.


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


Sr. No.


Approx. Weightage %

1 Drug development process 15 25% 2 Clinical development of drug 35 60% 3 Approval of New drugs 10 15% Total 60 100

Page 40 of 47

Detailed Syllabus

Theory:

1. Drug development process: 15 Introduction to Various Approaches to drug discovery

1. Pharmacological 2. Toxicological 3. IND Application 4. Drug characterization 5. Dosage form

2. Clinical development of drug: 35

1. Introduction to Clinical trials

2. Various phases of clinical trial.

3. Methods of post marketing surveillance

4. Abbreviated New Drug Application submission.

5. Good Clinical Practice – ICH, GCP, Central drug standard control organisation (CDSCO) guidelines

6. Challenges in the implementation of guidelines

7. Ethical guidelines in Clinical Research

8. Composition, responsibilities, procedures of IRB / IEC

9. Overview of regulatory environment in USA, Europe and India.

10. Role and responsibilities of clinical trial personnel as per ICH GCP a. Sponsor b. Investigators c. Clinical research associate d. Auditors e. Contract research coordinators f. Regulatory authority

11. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)

12. Informed consent Process

13. Data management and its components

14. Safety monitoring in clinical trials.

3. Approval of New drugs: 10 Investigational New Drug (IND) submission, format & content of IND, content of Investigator Brochure, general consideration of New Drug Approval (NDA), specific requirements, content & format of NDA, manufacturing control requirement of NDA.

Page 41 of 47

Books Recommended:

1. Cntral Drugs Standard Control Organization. Good Clinical Practices-Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health; 2001.

2. International Conference on Harmonisation of Technical requirements for registration of Pharmaceuticals for human use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice.E6; May 1996.

3. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi.

4. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March 2005, John Wiley and Sons.

5. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.

6. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition, Jan 2000, Wiley Publications.

7. Goodman & Gilman: JG Hardman, LE Limbard, 10th Edn. McGraw Hill Publications, 2001.

Page 42 of 47

SEMESTER-II

Advance Hospital pharmacy Management (PH813.06) Credits: 4: Theory Contact hrs per week: 4: Theory 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, Role of Pharmacist in PTC, Budget preparation & other preparations, drug information, patient counseling and therapeutic drug monitoring for improved patient care.

Outline of course:

Sr. No.


Approx. Weightage %

1 Hospital - its Organisation and functions

2 6

2 Hospital pharmacy-Organisation and management

5 10

3 The Budget – Preparation and implementation

5 10

4 Hospital drug policy 8 15 5 Hospital pharmacy services 12 25 6 Manufacture of Pharmaceutical

preparations 6 14

7 Continuing professional development programs

2 6

8 Radio Pharmaceuticals – Handling and packaging

2 6

9 Professional Relations and practices of hospital pharmacist

3 8

Total 60 100

Page 43 of 47

Detailed Syllabus Theory: 1 Hospital - its Organisation and functions 02

2 Hospital pharmacy-Organisation and management 05 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 05

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 12

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

6 Manufacture of Pharmaceutical preparations 06

a) Sterile formulations – large and small volume parenterals b) Manufacture of Ointments, Liquids, and creams

c) Manufacturing of Tablets, granules, capsules, and powders d) Total parenteral nutrition

7 Continuing professional development programs 02

Education and training

8 Radio Pharmaceuticals – Handling and packaging 02

9 Professional Relations and practices of hospital pharmacist 03

Page 44 of 47

Books Recommended:

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.

Page 45 of 47

SEMESTER II

CLINICAL PHARMACY PRACTICAL-III (PH813.07)

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


To make students familiar with methodology in Pharmacoherapeutics and biostatistics.


At the end of the course, the student will be able to learn cases based on clinical

Pharmacotherapeutics and bioststistics.


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

Part -I Discussion of hypothetical cases studies based on theory of Pharmacotherapeutics II Part- II: BiostisticPracticals Practicals to illustrate following topics in biostatics: Nonparametric methods,Experimental design in clinical trials, Analysis of variance, linear regression and correlation, Sample size and power determination,estimation and hypothesis testing, statistic for Bioavailability and Bioequevalance study, post hoc tests.

Page 46 of 47

SEMESTER II

CLINICAL PHARMACY PRACTICAL-IV(PH813.08)

______________________________________________________________________________

Credits: 3:Practical Contact hrs per week: 6: Theory (1 day) _________________________________________________________________________________________

Hospital postings in various departments designed to complement the lectures by providing practical clinical discussion; attending ward rounds; follow up the progress and changes made in drug therapy in allotted patients; case presentation upon discharge. Students are required to maintain a record of cases presented and the same should be submitted at the end of the course for evaluation. A minimum of 15 cases should be presented and recorded covering most common diseases.

Page 47 of 47

SEMESTER II

COMMUNITY SERVICES-II (PH824.04)

(PRACTICAL)

Credits: 1 Contact hrs per week: 3

Course Description

• Students are undertaking a group research project. Students of each group choosing

community service projects must commit at least 3 hours/week to their projects.

• Students in this course will have an opportunity to work collaboratively with community

partners to identify needs in communities.

• Students will investigate, discuss, and plan methods of addressing identified needs within the community.

• Under the guidance of the instructor or an advisor, students will be actively involved in implementing a self-designed community service project.

Course Goals

• Promote active learning and responsible citizenship.

• Identify personal values, beliefs, attitudes, and philosophies.

• Promote collaborative learning.

• Strengthen ties between student and community; and community and college.

• Foster a commitment of service to others. Course Objectives

• Develop interpersonal skills necessary for being an active participant in a community

• Develop a learning community

• Investigate and identify needs within a community

• Develop a plan of action for responding to an identified need of the community Course Evaluation

Projects selected in Community services-II will be in continuation with Community services-I.

Evaluation will be based on final presentation and final report preparation.

The performance of every student will be evaluated as follows: Approx. Weightage (%) Final report (assignment) 25 Final Presentation 75

Documents

M.Pharm.(Clinical Pharmacy)