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Full Description
While the field of biotechnology has made significant advancements in genomics, high-throughput screenings, and combinatorial and asymmetric syntheses, which have opened up new avenues for drug discovery, the industry is facing a serious innovation deficit. The number of new molecules registered annually has not increased as expected, and there have been post-marketing failures of blockbuster drugs, which have become major concerns for the industry. On the other hand, there is a global shift towards the use of traditional medicine involving complementary and alternative therapies. Ethnopharmacology and traditional medicines have made significant contributions in the past to the process of natural product drug discovery. There are two clear tracks where ethnopharmacology has the potential to contribute to future drug research. First, as a discovery engine to provide new targets, leads, and second, the use of quality-assured and standardized traditional medicines. In this context, it is essential to understand the mechanisms of drug discovery and pharmaceutical development, with a focus on herbal drugs and nutraceuticals. This book offers a historical perspective, future prospects, and the 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 books important features is providing excellent insights into Good Laboratory and Good Clinical Practices, along with very useful summary steps involved in filing IND or NDA for botanical products. The book also gives regulators perspectives on validating claims and how ethnopharmacological or traditional medicines require a different approach.
Contents
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
