About the Book:

This book describes all concepts, practices, methods and regulatory guidelines related to clinical research, clinical trials and pharmacovigilance in a simple, lucid and easily understandable manner and covers the entire syllabus prescribed by Pharmacy Council of India (PCI), New Delhi for Pharm.D and M. Pharm courses.

            The book provides a comprehensive knowledge of various aspects such as drug development and approval process, pharmacological and toxicological approaches and methods, pharmaceutical dosage form approaches for drug development, clinical approaches and clinical trials, phases, types, designs and statistical tests of clinical trials, regulatory aspects, GCP as per ICH, WHO, ICMR, Schedule Y and regulatory environment in US, Europe and India in 20 chapters. Special emphasis is given to Pharmacovigilance methods and Pharmacovigilance programme of India (PvPI).

            The book provides a comprehensive knowledge of all aspects of clinical research, clinical trials, GCP guidelines and Pharmacovigilance as per the requirements of clinical research industry and personnel. The subject is presented in a simple, lucid and easily understandable way in logical flow for the benefit of pharmacy students as well as industry persons. Latest practices and regulatory guidelines are included and hence the book provides updated knowledge.

Contents:

1.             Drug Discovery, Development and Approval Process: An Overview

2.             Approaches to Drug Discovery (Pharmacological and Toxicological)

3.             Drug Characterization, Preformulation and Dosage Form Development

4.             The Investigational New Drug (IND) Application and New Drug Application (NDA)

5.             Clinical Development of Drugs – Introduction and Evolution of Clinical Research

6.             Clinical Research Methodology (Phases, Types, Designs and Statistical Concepts of Clinical Trials

7.            Clinical Trials Research in India (Clinical Trial Phases, Process, Documentation and Regulations)

8.            Methods of Post Marketing Surveillance (PMS)

9.            Abbreviated New Drug Application (ANDA) Submissions

10.         Guidelines and Principles of Good Clinical Practices (ICH & WHO)

11.         Comparison of Clinical Trial Regulations in India, Europe and USA

12.         Challenges in the Implementation of GCP Guidelines

13.         Ethical Guidelines in Clinical Research

14.          Composition, Role and Responsibilities of Institutional Ethics Committee (IEC) in Clinical Trials

15.         Regulatory Environment in US, India and Europe

16.         Role and Responsibilities of Clinical Trial Personnel as per GCP

17.         Designing of Clinical Study Documents and Informed Consent Process

18.         Data Management in Clinical Research

19.         Safety Monitoring in Clinical Trials

20.         Pharmacovigilance

About the Author:

K. P. R. Chowdary is one of the senior most Professors of Pharmacy in the country, having 44 years of experience in teaching, research and administration in Pharmacy. He served as Professor, HOD and Principal of Andhra University College of Pharmaceutical Sciences, Visakhapatnam during 1977 to 2010. Presently he is serving as Research Director, Vikas Institute of Pharmaceutical Sciences, Rajahmundry since 2011; Chairman, BOS in Pharmacy, Jawaharlal Nehru Technological University Kakinada, Kakinada and Advisor KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada. He is actively involved in teaching and research in Pharmacy and has guided the research work of 101 Ph.D. scholars, 165 M.Pharm graduates and published 500 research papers in National and International journals of repute and obtained 05 patents. He has rich experience and expertise in teaching research methodologies, clinical research and related subjects to M.Pharm and PhD students of Pharmacy.