About the Book:

"Textbook on Clinical Research: A Guide for Aspiring Professionals and Professionals" is an essential resource for anyone entering the field of clinical research. This comprehensive guide explores the intricate world of clinical trials and bio-equivalency testing, emphasizing their crucial role in the discovery of groundbreaking treatments and medications.

            In a world struggling to bridge the gap between healthcare needs and available options, this book highlights the urgent need for more clinical research activities. Drawing on lessons learned during critical times such as the COVID-19 pandemic, the book stresses the importance of developing innovative and safer interventional tools.

            The book also sheds light on India's evolving landscape of clinical research, offering insights into the impact of separate Clinical Trial Rules and time-bound application reviews. These developments have promoted predictability and transparency in regulatory pathways, aligning with India's journey towards self-reliance in vaccine production and the nation's aspirations for 'Aatmanirbhar Bharat' (self-reliant India). The call for 'vocal for local' further reinforces the demand for skilled professionals to conduct clinical trials and advance clinical research in India.

Contents:

1.    Introduction

2.    Clinical Research in India

3.    Drug Development Process

4.    Clinical Trials

5.    Ethical Issues in Clinical Trials and Biomedical Research

6.    Good Clinical (Research) Practices (GCP) for Clinical Research in India

7.    Quality Assurance in Clinical Research

8.    Bioavailability and Bioequivalence Studies

9.    Clinical Trials of Ayurvedic Drugs

10.    Data Management in Clinical Research

About the Author:

Guru Prasad Mohanta is Former Professor and Head of the Department of Pharmacy of Annamalai University. He has the experience of serving World Health Organization as National Technical Officer in Essential Drugs and Medicines.

           He has more than 34 years of teaching, research and administrative experience at various levels with more than 500 articles to his credit. He is a regular columnist for Newspapers and Pharma Magazines. He has authored several popular texts and reference books. With his International Training background he has been advocating the rational use of medicines at various forums. He has completed projects supported by UGC, ICMR, HAI-AP, EPN, CDSCO, and WHO. He was the Coordinator of Peripheral Centre under National Pharmacovigilance Programme supported by World Bank. He is associated with several Indian Universities and Institutions either as member of academic bodies or examiners. He is a member of various National and International Professional Bodies. He has coordinated many continuing professional development programmes for pharmacy teachers and professional pharmacists. He is a trainer in Clinical Research, Pharmacovigilance, Medicine Supply Chain Management, Pharmacoeconomics, Rational Use of Medicines and Accreditation related areas.