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Full Description
Botanicals, which have been part of human food and medicine for thousands of years, are perceived as being safer than synthetic pharmaceuticals. The global botanical drug market was expected to reach $26.6 billion by 2017. In terms of FDA regulations, botanical drugs are no different from non-botanical products, having to meet the safety and effectiveness standards of a new drug in accordance. This book comprises a complete start-to-end process from drug-idea conception, to drug development process.
Key Features:
Provides a complete compendium for botanical drug products
Describes what BDP is and how it differs from Pharma, Biopharma, and Nutraceuticals
Compiles all critical regulatory steps in a variety of countries
Discusses clinical trial management for BDP development and how it differs from conventional chemical-based drugs and biopharmaceutics
Contents
1. Global Pharmaceuticals Industry and Botanical Drug Products 2. Regulatory Perspectives of Botanical Drug Products in Top Pharmaceutical Markets 3. Bioprospecting, Botany, Biodiversity, and Their Impact on Botanical Drug Development 4. Role of Reverse Pharmacology, Translational Medicine, and Indian System of Medicine in BDPs Development 5. Industrial Scale-Up Strategy and Manufacturing Technologies for Botanical Drug Products 6. The Role of Computational Approach in R&D of Botanical Drug Products 7. Botanical Drug Products of Ayurved, Indian System of Medicine in Integration with Other Metallopharmaceuticals, Nano Medical Devices, and Theranostics 8. The Quality, Safety, and Efficacy of Botanical Drugs 9. Botanical Drug Products and Rare Diseases 10. Botanical Drug Products Using Advanced Drug Delivery Systems: Recent Trends 11. Intellectual Property Rights for Botanical Drug Products 12. Evidence-Based Medicine, Safety, and Efficacy: Clinical Trial Management in Botanical Drug Products
