Drug Discovery and Development

The pharmaceutical industry is currently facing a significant innovation deficit, despite the potential offered by advances in genomics, high throughput screening, and combinatorial and asymmetric synthesis for drug discovery. The number of new molecules registered annually has actually decreased, contrary to expectations, and post-marketing failures of blockbuster drugs have become a major concern. On the other hand, there is a growing global trend towards the use of traditional medicine, including complementary and alternative therapies. Ethnopharmacology and traditional medicines have played a significant role in the past in the discovery of natural products, and there are two clear areas where ethnopharmacology can make a significant contribution to future drug research. First, as a discovery engine for new targets, leads, and second, the use of quality-assured and standardized traditional medicines. This book provides a historical perspective, future prospects, and the significance of ethnopharmacology in drug research, as well as important steps in botanical drug discovery and development, including bioprospecting, quality control, standardization, pharmaceutics, stability, pharmacokinetics, and bioavailability, with examples from ethnopharmacology and herbal medicine. The book also includes an excellent overview of Good Laboratory and Good Clinical Practices, as well as very useful summary steps for filing IND or NDA for botanical products. Additionally, the book provides the regulators perspective on validating claims and how ethnopharmacological or traditional medicines may require a different approach.

Professor Bhushan Patwardhan, PhD, FNASc, FNAMS National Research Professor-AYUSH, former Vice Chairman, University Grants Commission and Chairman Indian Council of Social Science Research. Member of several academic research and policy committees such as NITI Aayog, Planning Commission, Lancet Citizen's Commission, National Board of Examination, United Nations, World Health Organization Geneva. Fellow, National Academy of Sciences and National Academy of Medical Sciences (India). Founder Editor-in-Chief, Journal of Ayurveda and Integrative Medicine published by Elsevier. Recipient of several orations, awards, holds 8 Indian, 2 US Patents, 175+ scientific publications and 9800+ citations.