JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

This subject will provide different approaches to drug discovery, pharmacological,

toxicological and new drug applications. It will also impart knowledge about clinical trials, ICH guidelines and their implementation, rules and regulations of GCP, CDSCO and different protocols.

Course Outcome

Upon completion of the course, the student shall be able to,

• know approaches for drug discovery, Explain the regulatory requirements for conducting clinical trial
• Demonstrate the types of clinical trial designs
• Explain the responsibilities of key players involved in clinical trials
• know the regulations of GCP, ICH and different protocols.

UNIT - I

Drug development process: Introduction, Various Approaches to drug discovery, Pharmacological, Toxicological, IND Application, Drug characterization & Dosage form

UNIT - II

Clinical development of drug: a. Introduction to Clinical trials b. Various phases of clinical trial.

• c. Methods of post marketing surveillance d. Abbreviated New Drug Application submission.

UNIT - III

Good Clinical Practice – ICH, GCP, Central drug standard control organisation (CDSCO) guidelines, Challenges in the implementation of guidelines

UNIT - IV

Ethical guidelines in Clinical Research, Composition, responsibilities, procedures of IRB / IEC

UNIT - V

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

• a. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
• b. Informed consent Process
• c. Safety monitoring in clinical trials.

REFERENCE BOOKS:

• 1. Central 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.
• 8. Clinical Research: Principles, Practices, Perspectives, Bikash Medhi, Pharmamed Press M. Pharm I Year II Sem (PHARMACY PRACTICE)