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 Products [Ava Milani and Yashwant Pathak]

Dr. Jayant N. Lokhande, M.D.(Botanical Drugs) : MBA - Biotechnology is an expert in Botanical Drugs & Biotechnology Business Management. He has successfully strategized and formulated products for several nutraceutical, pharmaceutical and medical food companies in the United States and other developed countries. He has significant clinical experience especially in using Botanical Drugs and Medical Foods for Complex and Chronic Diseases. His other professional interests are in Biodiversity Entrepreneurship, Bio prospecting, Medical Anthropology, and Disease Reversal Therapeutics.He is currently working as Chief Scientific Officer and Management Analyst in Indus Extracts in US and his responsibilities include Business Analysis, Product and Technical Market Development. Yashwant Pathak, PhD, is currently the associate dean for faculty affairs at the newly launched College of Pharmacy, University of South Florida, Tampa, Florida. Pathak earned his MS and PhD degrees in pharmaceutical technology from Nagpur University, Nagpur, India, and EMBA and MS degrees in conflict management from Sullivan University, Louisville, Kentucky. With extensive experience in academia and industry, Pathak has over 120 publications, research papers, abstracts, book chapters, and reviews to his credit. He has presented over 150 presentations, posters, and lectures worldwide in the field of pharmaceuticals, drug delivery systems, and other related topics. He has also coedited six books on nanotechnology and drug delivery systems, two books on nutraceuticals, and several books on cultural studies. Pathak is the holder of two patents. He has travelled extensively to over 75 countries and is actively involved with many pharmacy colleges in different countries.