While biotechnological advances, genomics and high throughput screenings or combinatorial and asymmetric syntheses are opening new opportunities in drug discovery, the industry is facing serious innovation deficit. The total number of new molecules registered per year has dropped in contrast to expected increase. Post marketing failures of blockbuster drugs have become major concerns of industries. On the other side, globally there is a major shift to sue of traditional medicine involving complementary and alternative therapies. Ethnopharmacology and traditional medicines have contributed in past significantly in the process of natural product drug discovery. There are two clear tracks where ethnopharmacology has potential to contribute in future drug research. First, as a discovery engine to provide new targets, leads, and second, use of quality assured and standardized traditional medicines. In this scenario, it is important to understand the mechanisms of drug discovery and pharmaceutical development with a focus on herbal drugs and neutraceutical. This book provides historical perspective, future prospects and significance of ethnopharmacology in drug research. It also provides 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. One of the important feature of this book is to give an excellent insight to Good Laboratory and Good Clinical Practices along with very useful summary steps involved in filing IND or NDA of botanical products. The book also gives Regulators’ perspective of validating claims and how ethnopharmacological or traditional medicines need different approach.
Section I. Discovery: 1. Overview of medical and drug development. 2. TM/CAM and ethnopharmacology. 3. Natural product and drug discovery. 4. Innovation and drug discovery. 5. Bioprospecting and IPR. Section II. Development 6. Safety and regulatory issues. 7. Quality control and standardization. 8. Herbal pharmaceutics: stability and pharmacokinetics. 9. Preclinical and clinical evaluation. 10. Regulatory guidance to industry. 11. Validating of health claims and pharmacoepidemiology.Section III. Technology: 12. Biotechnology in herbal drug research. 13. Microarrays and high throughput screening. 14. Pharmacogenomics and ethnopharmacology. 15. Ethnoinformatics and AyuSoft. 16. Systems approaches and reverse pharmacology. 17. Future perspectives.