DRUG DISCOVERY AND CLINICAL RESEARCH
DRUG DISCOVERY AND CLINICAL RESEARCH
Second Edition
Chief Editor
SK Gupta PhD DSc FIPS FIACS
Distinguished Professor Delhi Pharmaceutical Sciences and Research University (DPSRU)
New Delhi, India
Formerly
Professor and Head Department of Pharmacology All India Institute of Medical Sciences (AIIMS) New Delhi, India
Co-Editor
Sushma Srivastava PhD PDCR
Senior Consultant Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Government of India Ghaziabad, Uttar Pradesh, India
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Drug Discovery and Clinical Research
First Edition: 2011
Second Edition: 2019
9789352705771
Printed at
- Abhishank Singh
- Research Manager
- Regulatory Affairs
- Sun Pharma
- New Delhi, India
- Amandeep Bhatia
- Pharmacopoeial Associate
- Indian Pharmacopoeia
- Commission
- Ministry of Health and Family Welfare Government of India
- Ghaziabad, Uttar Pradesh, India
- Arnab Chakraborty
- Business Analyst
- Global Pricing and Market Access
- Novartis
- Hyderabad, Telangana, India
- Babu S Nema
- Former Head
- Clinical Research Information
- Management
- Institute of Clinical Research India
- Bengaluru, Karnataka, India
- Dan McDonald
- Former Senior Vice President
- Business Strategy
- Excel Life Sciences
- Boston, Massachusetts, USA
- Diana Francis
- Research Associate
- Institute of Clinical Research India
- Bengaluru, Karnataka, India
- Divya Gaba
- Consultant
- Real-World Insights, Global
- Delivery Centre
- Quintiles IMS
- Gurugram, Haryana, India
- Jai Prakash
- Senior Principal Scientific Officer
- Indian Pharmacopoeia
- Commission
- Ministry of Health and Family Welfare Government of India
- Ghaziabad, Uttar Pradesh, India
- Mahendra Rai
- Practice Leader
- Health Economics and Outcomes Reach (HEOR) and Market Access
- Tata Consultancy Services
- Thane, Maharashtra, India
- Niranjan Galpalli
- Senior Scientist
- Lupin Bioresearch Center
- Pune, Maharashtra, India
- Prateek Sharma
- Research Scholar
- Delhi Institute of Pharmaceutical
- Sciences and Research (DIPSAR)
- New Delhi, India
- Pravina Koteshwar
- Consultant General Physician
- Gurukripa Clinic
- Bengaluru, Karnataka, India
- Puneet Agarwal
- Ophthalmologist
- Department of Ophthalmology
- International Medical University
- Bukit Jalil, Kuala Lumpur, Malaysia
- Rajani Mathur
- Assistant Professor
- Delhi Institute of Pharmaceutical
- Sciences and Research
- New Delhi, India
- Renu Agarwal
- Associate Professor and Head
- Department of Pharmacology
- Faculty of Medicine
- Universiti Teknologi MARA
- Selangor, Darul Ehsan, Malaysia
- Richa Goyal
- Senior Manager
- Real-Word Insights
- Quintiles IMS
- Gurugram, Haryana, India
- Satish Bhatia
- Former Consultant
- Clinical Development Services Agency
- Department of Biotechnology
- Ministry of Science and Technology
- Government of India
- Gurugram, Haryana, India
- Saurendra Das
- Executive Director
- Excel Life Sciences Inc.
- Noida, Uttar Pradesh, India
- Shubha R
- Former Member of Faculty
- Institute of Clinical Research of India
- Bengaluru, Karnataka, India
- Shwetha Ramakrishnan
- Clinical Data Manager
- Omnicare Clinical Research
- Bengaluru, Karnataka, India
- SK Gupta
- Distinguished Professor
- Delhi Pharmaceutical Sciences and Research University (DPSRU)
- New Delhi, India
- Formerly
- Professor and Head
- Department of Pharmacology
- All India Institute of Medical Sciences (AIIMS)
- New Delhi, India
- Sonal Vora
- Former Director
- Aventis Pharma Ltd.
- Mumbai, Maharashtra, India
- Srinivasan Senthilkumari
- Scientist
- Department of Ocular
- Pharmacology
- Aravind Medical Research
- Foundation (AMRF)
- Madurai, Tamil Nadu, India
- Suresh Bowalekar
- Former Managing Director
- Pharmanet Clinical Services Pvt, Ltd.
- Bengaluru, Karnataka, India
- Sushma Srivastava
- Senior Consultant
- Indian Pharmacopoeia Commission
- Ministry of Health and Family Welfare
- Government of India
- Ghaziabad, Uttar Pradesh, India
- V Kalaiselvan
- Principal Scientific Officer
- Indian Pharmacopoeia Commission
- Ministry of Health and Family Welfare
- Government of India
- Ghaziabad, Uttar Pradesh, India
With immense pleasure we present the Drug Discovery and Clinical Research keeping in view the radical shift in the attitude and policies of the pharma companies and the focus on new and sustainable drug development strategies. Recently, emphasis is being laid on the development of in vitro testing methods due to issues in availability of the animals. Hence, a chapter on Preclinical In Vitro Screening Methods to Predict Drug Safety during Drug Development Process has been included in the present edition. Apart from this, the field of drug discovery includes various challenges in terms of conduct of clinical trials and postmarketing surveillance.
In the past few years, a lot of changes have taken place in Clinical Trial Regulations in India. Several important amendments have been made in Drugs and Cosmetics Rules, 1945 from time-to-time with respect to the then existing circumstances. The clinical trials in India and their approvals by Ethics Committees came under surveillance by the regulatory agencies due to unethical practices in a few places which drew the attention of public. As a consequence, regulations were imposed for mandatory registration of Ethics Committees and clinical trials. Responsibilities of Sponsors, Investigators, etc. were defined by the amendments in Schedule Y. Considering this, a chapter on ‘Regulations for Conducting Clinical Trials in India’ and ‘Biosimilars’ have been included.
Some of the chapters have been incorporated from the book Basic Principles of Clinical Research and Methodology, published earlier, as these chapters did not require any changes.
This book will be useful for the postgraduate students, industry professionals and those engaged in clinical research and drug discovery at academia and pharmaceutical industry.
It is obvious that an enterprise of this magnitude has been possible due to the cooperation and assistance of a large number of individuals. As editors, we express our heartfelt gratitude to the contributors of the chapters, dedicated team of editorial board and the production staff of M/s Jaypee Brothers Medical Publishers (P) Ltd, New Delhi, India, who all joined to convert this dream project into reality.
SK Gupta
Sushma Srivastava
Preface to the First Edition
The pharmaceutical industry is one of the largest and most rapidly expanding industries in the world. In recent years, there has been a radical shift in the attitude and policies of pharmaceutical industry and the focus has been on new and sustainable drug development strategies. Innovations are not only desirable but also mandatory to meet the constantly evolving challenges in this highly competitive field. Numerous novel drugs including vaccines, biosimilars, herbal medicines, new chemical entities, etc. are in the pipeline, which are expected to revolutionize current treatment protocols.
The Drug Discovery and Clinical Research bandwagon has been joined by scientists and researchers from all fields including basic sciences, medical sciences, biophysicists, biotechnologists, statisticians, regulatory officials and many more. The joint effort and contribution from all is translating into the fast development of this multifaceted field. At the same time, it has become challenging for all stakeholders to keep abreast with the explosion in information. The race for the finish-line leaves very little time for the researchers to update themselves and keep tabs on the latest developments in the industry.
To meet these challenges, this book entitled Drug Discovery and Clinical Research has been compiled. All chapters have been written by stalwarts of the field who have their finger on the pulse of the industry. The aim of the book is to provide succinctly within one cover, an update on all aspects of this wide area. Although each of the chapter dealt here starting from drug discovery and development, clinical development, bioethics, medical devices, pharmacovigilance, data management, safety monitoring, patient recruitment, etc. are topics for full-fledged book in themselves, an effort has been made via this book to provide a bird's eye view to readers and help them to keep abreast with the latest development despite constraints of time. It is hoped that the book will contribute to the growth of readers, which should translate into drug discovery and clinical research industry's growth.
SK Gupta
Acknowledgments
We take this opportunity to congratulate the team of contributors for being part of this book that covers almost all important aspects of drug discovery, clinical research and pharmacovigilance. We extend our heartfelt gratitude to them for devoting their valuable time out of their busy schedule and pressing commitments in making this dream endeavor come true.
Our special acknowledgment is due to authors of Basic Principles of Clinical Research and Methodology whose chapters are included in this book. The authors are stalwarts in their fields and their chapters are adopted without any modifications keeping in view their importance and relevance in the book. We are grateful to Dr Saurendra Das for the chapter ‘Role of Clinical Research Coordinator and Clinical Research Associate in Clinical Trials’, Dr Satish Bhatia for ‘Bioequivalence Studies in Drug Development’, Drs Babu S Nema and Shwetha Ramakrishnan for ‘Clinical Data Management’ and Dr Suresh Bowalekar for ‘Biostatistics in Clinical Trials’ without which it would have been difficult to bring this book into its current form.
We are also deeply thankful to our colleagues and students at Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR) for their cooperation and help in this venture. We pay special thanks to our families without their support this task would have been meaningless.
We also acknowledge the support of the dedicated team of editorial board and the production staff of M/s Jaypee Brothers Medical Publishers (P) Ltd, New Delhi, India, for helping to make this dream project to become true.