A Textbook of Clinical Research and Pharmacovigilance

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.          This book is ideal for Pharm.D., M.Pharm, and PhD students of Pharmacy and also for research personnel involved in clinical research. 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