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Chapter-05 Clinical Development of New Drugs

BOOK TITLE: Drug Discovery and Clinical Research

Author
1. Gupta SK
2. Srivastava Sushma
3. Galpalli Niranjan
ISBN
9789352705771
DOI
10.5005/jp/books/18166_6
Edition
2/e
Publishing Year
2019
Pages
23
Author Affiliations
1. Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India; All India Institute of Medical Sciences (AIIMS), New Delhi, India, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
2. Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), MB Road, Pushp Vihar, Sector-3, New Delhi (India), All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India, Delhi Institute of Pharmaceutical, Sciences and Research, Pushp Vihar, Sector -3, New Delhi, India, Delhi Institute of Pharmaceutical, Sciences and Research, Pushp Vihar Sector-3, New Delhi, India, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), University of Delhi, New Delhi, India, Delhi Institute of Pharmaceutical Sciences and Research, University of Delhi, Pushp Vihar, Sector-3, New Delhi, India, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, India
3. Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), MB Road, Pushp Vihar, Sector-3, New Delhi (India), Lupin Bioresearch Center, Pashan, Pune (Maharashtra), India, Lupin Bioresearch Center, Pune, Maharashtra, India
Chapter keywords
Clinical development, drug discovery, clinical trial, new chemical entity, NCE, target validation, target identification, lead identification, lead optimization, investigational new drug, IND, human clinical trial, clinical trial design, clinical operation

Abstract

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