course title instrumental methods of analysis (theory)

Course Title Instrumental Methods of Analysis (Theory)

Course Code BP701T

Course Credit Lecture : 3

Practical : 0

Tutorial : 1

Total : 4

Course Objectives

Upon completion of the course the student shall be able to

• Understand the interaction of matter with electromagnetic radiations and its applications in

drug analysis

• Understand the chromatographic separation and analysis of drugs.

• Perform quantitative & qualitative analysis of drugs using various analytical instruments.

Detailed Syllabus

Unit No Name of Chapter & Details Hours Allotted

1 • UV Visible spectroscopy

Electronic transitions, chromophores, auxochromes, spectral shifts,

solvent effect on absorption spectra, Beer and Lambert’s law,

Derivation and deviations.

Instrumentation - Sources of radiation, wavelength selectors,

sample cells, detectors- Photo tube, Photomultiplier tube, Photo

voltaic cell, Silicon Photodiode.

Applications - Spectrophotometric titrations, Single component

and multi component analysis

• Fluorimetry

Theory, concepts of singlet, doublet and triplet electronic states,

internal and external conversions, factors affecting fluorescence,

quenching, instrumentation and applications

10

2 • IR spectroscopy

Introduction, fundamental modes of vibrations in poly atomic

molecules, sample handling, factors affecting vibrations

Instrumentation - Sources of radiation, wavelength selectors,

detectors - Golay cell, Bolometer, Thermocouple, Thermister,

Pyroelectric detector and applications

• Flame Photometry

Principle, interferences, instrumentation and applications

• Atomic absorption spectroscopy

Principle, interferences, instrumentation and applications

• Nepheloturbidometry

Principle, instrumentation and applications

10

3 • Introduction to chromatography

a. Adsorption and partition column chromatograph

Methodology, advantages, disadvantages and applications.

b. Thin layer chromatography

Introduction, Principle, Methodology, Rf values, advantages,

disadvantages and applications.

c. Paper chromatography

Introduction, methodology, development techniques, advantages,

disadvantages and applications

d. Electrophoresis

Introduction, factors affecting electrophoretic mobility, Techniques

of paper, gel, capillary electrophoresis, applications

10

4 • Gas chromatography

Introduction, theory, instrumentation, derivatization, temperature

programming, advantages, disadvantages and applications

• High performance liquid chromatography (HPLC)

08

Introduction, theory, instrumentation, advantages and applications.

5 • Ion exchange chromatography

Introduction, classification, ion exchange resins, properties,

mechanism of ion exchange process, factors affecting ion exchange,

methodology and applications

• Gel chromatography

Introduction, theory, instrumentation and applications

• Affinity chromatography

Introduction, theory, instrumentation and applications

07

Reference Books:

1. Instrumental Methods of Chemical Analysis by B.K Sharma

2. Organic spectroscopy by Y.R Sharma

3. Text book of Pharmaceutical Analysis by Kenneth A. Connors

4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel

5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake

6. Organic Chemistry by I. L. Finar

7. Organic spectroscopy by William Kemp

8. Quantitative Analysis of Drugs by D. C. Garrett

9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi

10. Spectrophotometric identification of Organic Compounds by Silverstein

Course Title Industrial Pharmacy II (Theory)

Course Code BP702T


Practical : 0

Tutorial : 1

Total : 4

Course Objectives

Upon completion of this course the student shall be able to

• Know the process of pilot plant and scale up of pharmaceutical dosage forms

• Understand the process of technology transfer from lab scale to commercial batch

• Know different Laws and Acts that regulate pharmaceutical industry

• Understand the approval process and regulatory requirements for drug products

Detailed Syllabus


1 • Pilot plant scale up techniques

General considerations - including significance of personnel

requirements, space requirements, raw materials, Pilot plant scale

up considerations for solids, liquid orals, semi solids and relevant

documentation, SUPAC guidelines, Introduction to platform

technology

10

2 • Technology development and transfer:

WHO guidelines for Technology Transfer(TT): Terminology,

Technology transfer protocol, Quality risk management, Transfer

from R & D to production (Process, packaging and cleaning),

Granularity of TT Process (API, excipients, finished products,

packaging materials) Documentation, Premises and equipment,

qualification and validation, quality control, analytical method

10

transfer, Approved regulatory bodies and agencies,

Commercialization - practical aspects and problems (case studies),

TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT

related documentation - confidentiality agreement, licensing,

MoUs, legal issues

3 • Regulatory affairs

Introduction, Historical overview of Regulatory Affairs, Regulatory

authorities, Role of Regulatory affairs department, Responsibility of

Regulatory Affairs Professionals

• Regulatory requirements for drug approval:

Drug Development Teams, Non-Clinical Drug Development,

Pharmacology, Drug Metabolism and Toxicology, General

considerations of Investigational New Drug (IND) Application,

Investigator’s Brochure (IB) and New Drug Application (NDA),

Clinical research / BE studies, Clinical Research Protocols,

Biostatistics in Pharmaceutical Product Development, Data

Presentation for FDA Submissions, Management of Clinical Studies.

10

4 • Quality management systems:

Quality management & Certifications: Concept of Quality, Total

Quality Management, Quality by Design (QbD), Six Sigma concept,

Out of Specifications (OOS), Change control, Introduction to ISO

9000 series of quality systems standards, ISO 14000, NABL, GLP

08

5 • Indian Regulatory Requirements:

Central Drug Standard Control Organization (CDSCO) and State

Licensing Authority: Organization, Responsibilities, Certificate of

Pharmaceutical Product (COPP), Regulatory requirements and

approval procedures for New Drugs.

07

Instructional Method and Pedagogy:

• Lectures will be conducted with the aid of multi-media projector, black board, OHP etc.

• Specific discussion questions will be assigned each week. It is important that everyone

participate in the discussion.

• Unit Review Quizzes will measure the student’s understanding of the material.

Students Learning Outcomes

• This course is designed to impart fundamental knowledge on pharmaceutical product

development and translation from laboratory to market

Recommended Books: (Latest Editions)

1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at

http,//en.wikipedia.org/wiki/Regulatory_ Affairs.

2. International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php

3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for

Prescription Drugs, Medical Devices, and Biologics’ Second Edition.

4. Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm

Course Title Pharmacy Practice (Theory)

Course Code BP703T


Practical : 0

Tutorial : 1

Total : 4

Course Objectives


• Know various drug distribution methods in a hospital

• Appreciate the pharmacy stores management and inventory control

• Monitor drug therapy of patient through medication chart review and clinical review

• Obtain medication history interview and counsel the patients

• Identify drug related problems

• Detect and assess adverse drug reactions

• Interpret selected laboratory results (as monitoring parameters in therapeutics) of specific

disease states

• Know pharmaceutical care services

• Do patient counseling in community pharmacy

• Appreciate the concept of Rational drug therapy

Detailed Syllabus


1 a) Hospital and it’s organization

Definition, Classification of hospital- Primary, Secondary and Tertiary

hospitals, Classification based on clinical and non- clinical basis,

Organization Structure of a Hospital, and Medical staffs involved in the

hospital and their functions.

b) Hospital pharmacy and its organization

10

Definition, functions of hospital pharmacy, Organization structure,

Location, Layout and staff requirements, and Responsibilities and

functions of hospital pharmacists.

c) Adverse drug reaction

Classifications - Excessive pharmacological effects, secondary

pharmacological effects, idiosyncrasy, allergic drug reactions,

genetically determined toxicity, toxicity following sudden withdrawal

of drugs, Drug interaction- beneficial interactions, adverse

interactions, and pharmacokinetic drug interactions, Methods for

detecting drug interactions, spontaneous case reports and record

linkage studies, and Adverse drug reaction reporting and management.

2 a) Drug distribution system in a hospital

Dispensing of drugs to inpatients, types of drug distribution systems,

charging policy and labelling, Dispensing of drugs to ambulatory

patients, and Dispensing of controlled drugs.

b) Hospital formulary

Definition, contents of hospital formulary, Differentiation of hospital

formulary and Drug list, preparation and revision, and addition and

deletion of drug from hospital formulary.

c) Therapeutic drug monitoring

Need for Therapeutic Drug Monitoring, Factors to be considered

during the Therapeutic DrugMonitoring, and Indian scenario for

Therapeutic Drug Monitoring.

d) Medication adherence

Causes of medication non-adherence, pharmacist role in the

medication adherence and monitoring of patient medication

adherence.

e) Patient medication history interview

10

Need for the patient medication history interview, medication

interview forms.

f) Community pharmacy management

Financial, materials, staff, and infrastructure requirements.

3 a) Pharmacy and therapeutic committee

Organization, functions, Policies of the pharmacy and therapeutic

committee in including drugs into formulary, inpatient and outpatient

prescription, automatic stop order, and emergency drug list

preparation.

b) Drug information services

Drug and Poison information centre, Sources of drug information,

Computerised services, and storage and retrieval of information.

c) Patient counseling

Definition of patient counseling; steps involved in patient counseling,

and Special cases that require the pharmacist

d) Education and training program in the hospital

Role of pharmacist in the education and training program, Internal and

external training program, Services to the nursing homes/clinics, Code

of ethics for community pharmacy, and Role of pharmacist in the

interdepartmental communication and community health education.

e) Prescribed medication order and communication skills

Prescribed medication order- interpretation and legal requirements,

and Communication skills- communication with prescribers and

patients.

10

4 a) Budget preparation and implementation

Budget preparation and implementation

b) Clinical Pharmacy

08

Introduction to Clinical Pharmacy, Concept of clinical pharmacy,

functions and responsibilities of clinical pharmacist, Drug therapy

monitoring - medication chart review, clinical review, pharmacist

intervention, Ward round participation, Medication history and

Pharmaceutical care.

Dosing pattern and drug therapy based on Pharmacokinetic & disease

pattern.

c) Over the counter (OTC) sales

Introduction and sale of over the counter, and Rational use of common

over the counter medications.

5 a) Drug store management and inventory control

Organisation of drug store, types of materials stocked and storage

conditions, Purchase and inventory control: principles, purchase

procedure, purchase order, procurement and stocking, Economic

order quantity, Reorder quantity level, and Methods used for the

analysis of the drug expenditure

b) Investigational use of drugs

Description, principles involved, classification, control, identification,

role of hospital pharmacist, advisory committee.

c) Interpretation of Clinical Laboratory Tests

Blood chemistry, haematology, and urinalysis

07


▪ Lectures will be conducted with the aid of multi-media projector, black board, OHP etc.

▪ Assignments based on course content will be given to the students at the end of each

unit/topic and will be evaluated at regular interval.

▪ Surprise tests/Quizzes/Seminar/Tutorials will be conducted.

▪ The course includes language practices such as Group Discussion, Interviews etc to develop

▪ the communication skills of the students.


1. Merchant S.H. and Dr. J.S.Quadry. A textbook of hospital pharmacy, 4th ed. Ahmadabad: B.S.

Shah Prakakshan; 2001.

2. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of Clinical Pharmacy

Practice- essential concepts and skills, 1st ed. Chennai: Orient Longman Private Limited; 2004.

3. William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger; 1986.

4. Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.

5. Scott LT. Basic skills in interpreting laboratory data, 4thed. American Society of Health System

Pharmacists Inc; 2009.

6. Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBS Publishers &

Distributers; 2008.

Journals

1. Therapeutic drug monitoring. ISSN: 0163-4356

2. Journal of pharmacy practice. ISSN : 0974-8326

3. American journal of health system pharmacy. ISSN: 1535-2900 (online)

4. Pharmacy times (Monthly magazine)

Students Learning Outcomes:

• By the end of this course, the student should have a good understanding of the hospital

organization and formulary. Students can also know what is the working procedure in

hospital as pharmacist in various departments.

• Students should be able to know the role of community pharmacy services in hospital.

Students can also be able to work as a community pharmacist as a part of Health Care

system.

Course Title Novel Drug Delivery Systems (Theory)

Course Code BP704T


Practical : 0

Tutorial : 1

Total : 4

Course Objectives


• To understand various approaches for development of novel drug delivery systems.

• To understand the criteria for selection of drugs and polymers for the development of

Novel drug delivery systems, their formulation and evaluation

Detailed Syllabus


1 • Controlled drug delivery systems:

Introduction, terminology/definitions and rationale, advantages,

disadvantages, selection of drug candidates. Approaches to design

controlled release formulations based on diffusion, dissolution and

ion exchange principles. Physicochemical and biological properties

of drugs relevant to controlled release formulations

• Polymers:

Introduction, classification, properties, advantages and application

of polymers in formulation of controlled release drug delivery

systems.

10

2 • Microencapsulation:

Definition, advantages and disadvantages,

microspheres/microcapsules, microparticles, methods of

microencapsulation, applications

10

• Mucosal Drug Delivery system:

Introduction, Principles of bioadhesion/mucoadhesion, concepts,

advantages and disadvantages, transmucosal permeability and

formulation considerations of buccal delivery systems

• Implantable Drug Delivery Systems:

Introduction, advantages and disadvantages, concept of implants

and osmotic pump

3 • Transdermal Drug Delivery Systems:

Introduction, Permeation through skin, factors affecting

permeation, permeation enhancers, basic components of TDDS,

formulation approaches

• Gastroretentive drug delivery systems:

Introduction, advantages, disadvantages, approaches for GRDDS –

Floating, high density systems, inflatable and gastroadhesive

systems and their applications

• Nasopulmonary drug delivery system:

Introduction to Nasal and Pulmonary routes of drug delivery,

Formulation of Inhalers (dry powder and metered dose), nasal

sprays, nebulizers

10

4 • Targeted drug Delivery:

Concepts and approaches advantages and disadvantages,

introduction to liposomes, niosomes, nanoparticles, monoclonal

antibodies and their applications

08

5 • Ocular Drug Delivery Systems:

Introduction, intra ocular barriers and methods to overcome –

Preliminary study, ocular formulations and ocuserts

07

• Intrauterine Drug Delivery Systems: Introduction, advantages and

disadvantages, development of intra uterine devices (IUDs) and

applications


1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel Dekker,

Inc., New York, 1992.

2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker, Inc., New York,

1992.

3. Encyclopedia of Controlled Delivery. Edith Mathiowitz, Published by Wiley Interscience

Publication, John Wiley and Sons, Inc, New York. Chichester/Weinheim

4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New Delhi, First

edition 1997 (reprint in 2001).

5. S.P. Vyas and R.K. Khar, Controlled Drug Delivery -concepts and advances, Vallabh Prakashan,

New Delhi, First edition 2002.

Journals

1. Indian Journal of Pharmaceutical Sciences (IPA)

2. Indian Drugs (IDMA)

3. Journal of Controlled Release (Elsevier Sciences)

4. Drug Development and Industrial Pharmacy (Marcel & Decker)

5. International Journal of Pharmaceutics (Elsevier Sciences)


▪ Lectures will be conducted with the aid of multi-media projector, black board, OHP etc.

▪ Assignments based on course content will be given to the students at the end of each

unit/topic and will be evaluated at regular interval.

▪ Surprise tests/Quizzes/Seminar/Tutorials will be conducted.

▪ The course includes language practices such as Group Discussion, Interviews etc to develop

▪ the communication skills of the students.

Course Title Instrumental Methods of Analysis (Practical)

Course Code BP705P


Practical : 2

Tutorial : 0

Total : 2

Course Objectives

Upon the completion of the course, students will be able to:

• Understand the interaction of matter with electromagnetic radiations and its applications in

drug analysis

• Understand the chromatographic separation and analysis of drugs.

• Perform quantitative & qualitative analysis of drugs using various analytical instruments.

Detailed Syllabus

Experiments Hours Allotted

1. Determination of absorption maxima and effect of solvents on absorption

maxima of organic compounds

2. Estimation of dextrose by colorimetry

3. Estimation of sulfanilamide by colorimetry

4. Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy

5. Assay of paracetamol by UV- Spectrophotometry

6. Estimation of quinine sulfate by fluorimetry

7. Study of quenching of fluorescence

8. Determination of sodium by flame photometry

9. Determination of potassium by flame photometry

10. Determination of chlorides and sulphates by nephelo turbidometry

11. Separation of amino acids by paper chromatography

12. Separation of sugars by thin layer chromatography

4 hrs/week

13. Separation of plant pigments by column chromatography

14. Demonstration experiment on HPLC

15. Demonstration experiment on Gas Chromatography

Recommended Books:

1. Instrumental Methods of Chemical Analysis by B.K Sharma

2. Organic spectroscopy by Y.R Sharma

3. Text book of Pharmaceutical Analysis by Kenneth A. Connors

4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel

5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake

6. Organic Chemistry by I. L. Finar

7. Organic spectroscopy by William Kemp

8. Quantitative Analysis of Drugs by D. C. Garrett

9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi

10. Spectrophotometric identification of Organic Compounds by Silverstein

Course Title Practice School (Pharmaceutics)

Course Code BP706PS

Course Credit Total : 06

Course Objectives

Upon completion of the course the student shall be able to

• Able to recognize the basics of Pharmaceutical Preformulation

• Able to recognize the basics of Pharmaceutical Formulation Research (Formulation and

Development)

• Able to categorize the global pharmaceutical markets (regulated and non-regulated markets)

• Learn basics of record keeping and record management system

• Skilled in the practice of documentation and reporting

• Having the knowledge of actual Pharmaceutical Production

• Equipped with the necessary basic technical knowledge of Industrial Pharmacy

• Understand and communicate effectively with the Industrial hierarchy

Detailed Syllabus


1 • Preformulation: A Pharmaceutical Industry Perspective

• Concept of Pharmaceutical Formulation and Development

• Categorization of Global Pharmaceutical Markets

• Various sections/departments of a pharmaceutical industry

• Pharmaceutical production plant layout for different dosage forms

• Record Keeping and Record Management systems

• Hierarchy in Pharmacy Company

• Documentation and Reporting Practice

45

2 • Practical demonstration of the aspects listed in Unit 1 (wherever

applicable)

45

3 • An Industrial Training at an Pharmaceutical Production Unit to Gain

Exposure of Actual Pharmaceutical Production

90


At the end of the course the students will be able to:

• understand the various aspects of Pharmaceutics: Preformulation, Formulation and

Development, Layout and Operation of actual Pharmaceutical Industry

• understand the Regulations Applicable to Pharmaceutical Industries

• know the importance of Systematic Record Keeping and Documentation

• be familiarize with the actual Working Environment of a Pharmaceutical Industry

Reference Books:

1. Remington: The Science and Practice of Pharmacy by Joseph Remington 20th Edition by

Alfonso Gennaro, Lippincott Williams & Wilkins Publishers.

2. Pharmaceutical Preformulation and Formulation 2nd Edition by Mark Gibson, (Marcel Dekker)

3. Pharmaceutical Manufacturing Handbook: Production and Processes by Shayne Cox Gad,

Wiley-Interscience Publishers.

4. Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management

and Regulatory Affairs by V. B. Patravale, CRC Press.

Additional Resources:

• https://www.pharmamanufacturing.com/

• https://www.fda.gov/home

• https://cdsco.gov.in/opencms/opencms/en/Home/

Course Title Practice School (PHARMACOGNOSY - TRADITIONAL DRUGS AND SYSTEMS

OF MEDICINE)

Course Code BP706PS


Course Objectives

On the completion of the course, students will be able to:

• Understand various aspects of crude drugs belong to traditional systems of medicines.

• Understand an importance of traditional drugs.

• Apply, interpret and analyses the knowledge of modern science for Traditional Ayurvedic drugs

and formulation

• Perform practical related to microscopy of traditional drugs to identify them

Detailed Syllabus


1 Study of the following traditional drugs, their vernacular names,

biological sources, cultivation, collection, commercial varieties,

official varieties, chemical constituents, substitutes, adulterants,

common and ethnomedicinal uses, trade, research and

formulations: Harde, Baheda, Amla, Shatavari, Ashwagandha, Tulsi,

Nagod, Rasna, Punarnava, Chitrak, Apamarg, Gokhru,

Shankhapusphi, Brahmi, Ardusi, Methi, Palash, Gudmaar, Neem,

Lahsun, Guduchi, Karanj, Pipar, Chirata, Kalmegh, Bhringraj, Haldi,

Adrakh, Aaragvadh, Hing

45

2 • Traditional Drugs And Systems Of Medicine (Practical)

1. Morphological and Microscopical study of traditional drugs.

2. Comparison of various species, especially controversial drugs.

3. Identification of medicinal plants and crude drugs.

4. Preparation of Traditional formulation e.g. Ayurvedic

90

3 • Traditional Drugs And Systems Of Medicine (Practical)

1. Visit & training at Ayurvedic hospitals & participate in their

medical camps

2. Visit & training at Herbal/traditional medicine research

laboratories & industries

3. Training at retail herbal / traditional medical store

4. Visit to Herbal medicinal gardens or forest reserves

45


• Lectures will be conducted in the medicinal garden

• Assignments based on course content will be given to the students

• The course includes language practices such as Group Discussion, Interviews etc to develop the

communication skills of the students.

• The course also includes preparation of report of visit to retail traditional medical store,

ayurvedic hospital, herbal medicinal garden, traditional medicinal industries and research

laboratories working on traditional medicine



• Understand various aspect of Traditional medicinal plants in practical situation at medicinal

garden, traditional healer hospital, traditional medical store, and herbal medicinal industry /

research centers

• Understand importance of Ayurvedic systems of medicines and crude drugs belongs to it.

• Able to apply knowledge of modern medical science concept to traditional medicines and

interpret level of usefulness of particular traditional medicines

Text/Reference Books

1. Shah and Qadry’s Pharmacognosy: J. S. Qadry, 14th edition, B S Shah Prakashan, Ahmedabad.

2. The Wealth of India, Publications and Information Directorate, CSIR, Hillside road, New Delhi.

3. Indian medicinal plants, K. R. Kirtikar & B. D. Basu, Vol. 1, 2nd ed., 2005, International Book

Distributor, Dehradun, India.

4. Indian medicinal plants, C. P. Khare, 2007, Springer Verlag Berlin.

5. Ayurvedic Pharmacopoeia of India (latest edition)

6. Ayurvedic Formulary of India (latest edition)

7. Indian Pharmacopoeia – Vol. III (latest edition)


• Govt. websites related to medicinal plants

Course Title Practice School (Pharmacology)

Course Code BP706PS


Course Objectives


• To create sound knowledge about basic applications of pharmacology in clinical settings.

• To Practice concepts of clinical practice in community.

• More effective in practicing concept of real pharmacy practice like prescription audit, drug

formulation evaluation, identifying ADRs, drug-drug interactions, concept of essential and

rational drug usage, modern compounding practice, ADR reporting, patients counselling.

Detailed Syllabus


1 • Study management of CVS, CNS, Endocrine, Infectious, Cancer,

Respiratory, GIT, Immunity, GIT disorders.

• Interpretation of laboratory biomarker and other tests for diseases

• Drug therapy for geriatrics, pediatrics and pregnant women.

• Concept of TPN and ICU management

• Concept of dialysis

• Patient counseling concept

• Therapeutic Drug Monitoring concept

45

2 • Clinical Pharmacy (Practical)

1. To audit given prescription for format of prescription, essentiality

and rationality and suggest carry home message (three experiments

containing three prescriptions each, in totality nine prescriptions,

covering various diseases or organ-systems.

2. To evaluate formulations – Antibiotics, chemotherapy, CVS, CNS,

Endocrine, GIT, Immunology, Vaccine, Immunomodulatory,

90

Respiratory etc.

3. To evaluate drug-drug interactions for the type of drug interaction,

the mechanism responsible for drug interactions, possible

outcomes or clinical manifestations of interaction and suggestion

corrective measure to overcome or prevent the drug interaction (at-

least 50 drug-drug interactions).

4. To evaluate cases for Interpretation of laboratory data

5. To evaluate cases for management of CVS, CNS, Endocrine,

Infectious, Cancer, Respiratory, GIT, Immunity, GIT disorders.

6. Collecting information for a given drug (Preferably recently

approved drugs) regarding adverse drug reactions, drug interactions

and contraindications using authenticated sources (Recent text

books, Latest Journals and online drug data bases such as

medscape).

3 • Clinical Pharmacy (Field Work)

A. Hospital Training: Project Based Learning

1. Detail of equipment in hospital

2. Detail of life saving instruments in ICU with purpose

3. Life Saving medicines in ICU

4. Dialysis procedure and use of equipment.

5. Ward round participation

6. Management of CVS disorders (5 Case)

- Pharmacological – (write –use of drugs, dosage forms,

Combinations, indications, adverse drug reactions)

- Non Pharmacological approach

- Instrument use / surgical therapy

7. Management of CNS disorders (5 Case)


45




8. Management of other disorders (5 Case)





B. Community Pharmacy –

- Visit to CHC and PHC

- Understand immunization Programme, drug store management,

treatment therapy at PHC and CHC etc.

C. Medical Store Training:

a. Drug store management (Handling of drugs)

b. Software use in drug store

c. Prescription reading and understanding

d. Dispensing of medicines

e. OTC, BTC and POM concept

f. Schedule H drug monitoring

g. D and C Act - understand


• Lectures will be conducted in the computer lab with online study.

• Assignments based on course content will be given to the students

• Preparation of drug data bank

• The course includes language practices such as Group Discussion, Interviews etc. to develop

the communication skills of the students.

• The course also includes preparation of report of visit to medical store, hospital, community

health center and primary health center, Industrial visit and research laboratories working on

clinical research.

• At the end of the practice school, every student shall submit a printed report (in triplicate) on

the practice school he/she attended (not more than 25 pages).



• To evaluate the correct drug for disease with suitable dose, route of administration and

formulation along with necessary precautions.

• To analyze the importance of proper selection of drug otherwise resulting in drug interactions

and adverse drug reactions.

• To apply the principle concepts of drug selection in management of diseases in special group of

patients like pediatric, geriatric and pregnant women

• To practice of reporting of ADR.

• Able to practice health awareness in community.

• Acquired skill to run and manage medical store effectively.

• To understand policy and regulation of Drug and cosmetic act.

Text Books:

1. Text Book of Therapeutics: Drug and Disease Management. 8th Ed. Editors: Eric T.Herfindal and

Dick R. Gurley, Williams and Wilkins, 2006

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

Edinburgh / London,4th ed,2008

3. A text book of Clinical Pharmacy Practice (Essential concepts and skills). G. Parthasarhi, Karin

Nyfort-Hansen & Milap C Nahata. University Press impression, 2008

Reference Books:

1. Pathology & Therapeutics for Pharmacists. Russell J. Greene and Norman F. Harris. Chapman &

Hall, London / Glasgow / Madras.

2. Davidson’s Principle and Practice of Medicine, Eds. Christopher R.W. Edwards & Ian A.D.

Boucher ELBS with Churchill Livingstone, Edinburgh.

3. Applied Therapeutics: The Clinical Use of Drugs Eds. Brian S. Katcher, Lloyd Yee Young, Marry

Anne Koda-Kimble, Applied Therapeutics Inc.

4. Melmon and Morrelli’s Clinical Pharmacology, 4th Edition. Authors:S.George Carrathers, Brian

B. Hoffman, Kenneth L. Melmon and David W. Nierenberg. McGraw Hill, 2000.

5. Pharmacotherapy: A Pathophysiological Approach. J. T. Dipiro, R. L. Talbert et al, McGraw-Hill,

New York


• D and C act

• ICMR and other government official website

• CDSCO

Course Title Practice School (PHARMACEUTICAL CHEMISTRY- ADVANCED INDUSTRIAL

INSTRUMENTAL TRAINING AND VALIDATION)

Course Code BP706PS


Course Objectives


• Learn the basics of instrumentation and classification of instruments, learn about the errors in

measurements, familiarize with the tools used in the industry, familiarize with electrical

analog, digital instruments.

• Equipped with the necessary knowledge, technical, creative and managerial skills in

instrumentation.

• Develop strong technical knowledge for establishing instrumentation-based automation

system in various industries.

• Apply the knowledge of validation to instruments and validate the manufacturing facilities.

• Communicate effectively with the Industrial hierarchy.

Detailed Syllabus


1 • Introduction, Definition of Validation and Calibration, Advantage

of Validation and calibration, Validation Master Plan as per

industrial point of view.

• General principles, Validation of analytical method as per ICH

guidelines and USP

• Online video on advanced instrument used in industrial perspective.

• Accurate Report writing and Presentation skill on advanced

industrial instrumental training and validation

60

2 • Advanced Industrial Instrumental Training and Validation (Practical)

1. Calibration of any two-laboratory instrument as per ICH guidelines.

60

2. To study validation parameters of any two-laboratory instrument

with pharmaceutical preparations as per ICH guidelines.

3. Important methodology used for calibration and validation as per

industrial point of view.

4. Online demonstration on instrumentation-based automation

system through video lecture.

3 • Advanced Industrial Instrumental Training and Validation (Industry

visit): Visit at various nearby industries/Institute for handling and

training on advanced Industrial Instruments.

60


• Lectures will be conducted in classroom via power point presentation and projector.

• Assignments based on course content will be given to the students.

• The course also includes preparation of report of visit at various nearby industries/Institute for

handling and training on advanced Industrial Instruments.



• understand the advanced instruments used and its applications in drug analysis.

• understand the calibration of various analytical instruments

• know analysis of drugs using various analytical instruments.

• Understand the validation and its parameters as per guidelines.

Reference Books

1. B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and Pharm Sci. Series,

Vol. 129, 3rd Ed., Marcel Dekker Inc., N.Y.

2. Analytical Method validation and Instrument Performance Verification by Churg Chan, Heiman

Lam, Y.C. Lee, Yue. Zhang, Wiley Inter Science.

3. Validation of Aseptic Pharmaceutical Processes, 2nd Edition, by Carleton & Agalloco, (Marcel

Dekker).


• https://www.intechopen.com/books/calibration-and-validation-of-analytical-methods-a-

sampling-of-current-approaches/validation-of-analytical-methods

• https://www.ema.europa.eu/en/ich-q2-r1-validation-analytical-procedures-text-methodology

course title instrumental methods of analysis (theory)

Documents