Botanical Drug Products: Recent Developments and Market Trends

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 1. Global Pharmaceuticals Industry and Botanical Drug Products [Jayant N. Lokhande and Sonali Lokhande] 2. Regulatory Perspectives of Botanical Drug Products in Top Pharmaceutical Markets [Grace Checo, Jayant N. Lokhande, and Sonali Lokhande] 3. Bioprospecting, Botany, Biodiversity, and Their Impact on Botanical Drug Development [Suma Krishnaswamy] 4. Role of Reverse Pharmacology, Translational Medicine, and Indian System of Medicine in BDPs Development [Jayant N. Lokhande, Sonali Lokhande, and Ganesh Shinde] 5. Industrial Scale-Up Strategy and Manufacturing Technologies for Botanical Drug Products [Rahul Maheshwari, Kaushik Kuche, Ashika Advankar, Namrata Soni, Piyoosh Sharma, Muktika Tekade, and Rakesh Kumar Tekade] 6. The Role of Computational Approach in R&D of Botanical Drug Products [Aniko Nagy, Markie Esmailian, and Timea Polgar] 7. Botanical Drug Products of Ayurved, Indian System of Medicine in Integration with Other Metallopharmaceuticals, Nano Medical Devices, and Theranostics [Jayant N. Lokhande, Sonali Lokhande, Sameer Mahajan, Ganesh Shinde, and Yashwant Pathak] 8. The Quality, Safety, and Efficacy of Botanical Drugs [Kimberly Palatini and Slavko Komarnytsky] 9. Botanical Drug Products and Rare Diseases [Jayant N. Lokhande and Sonali Lokhande] 10. Botanical Drug Products Using Advanced Drug Delivery Systems: Recent Trends [Param Patel, Anas Hanini, Achal Shah, Adam Mohamed, Kareem Elgendi, and Yashwant Pathak] 11. Intellectual Property Rights for Botanical Drug Products [Vishal Katariya and Kavita Gupta] 12. Evidence-Based Medicine, Safety, and Efficacy: Clinical Trial Management in Botanical Drug