Description
Business Horizons Regulatory Roadmap For Herbal Medicines by G Sudesh Kumar
The book is a roadmap for plant-derived medicine to move through regulatory, quality and intellectual property-related aspects either as a drug or a dietary supplement in global market place. It provides strategies to navigate through the available regulatory and market landscape, through innovation and standardization. A brief review of trends in patents based on herbal products and the legal hurdles faced in the protection of traditional medicines and marketing of these products in international markets is also covered. CONTENTS Preface Caring for Health, Naturally! Introduction The New Ancient Thinking in Medicine The Rise of Asia: Continental Drift PharmAsia: Generic Solutions Herbal Medicine: Aging Roots and Sprouting Branches China: The Power of Chi Ayurveda: Healing Trinity Europe: Doctrine of Signatures Modern Medicine: Designs from Nature Better Pill to Swallow: Synthetic Drugs or Herbal? Food versus Drug Administration of Herbs Middle Path: Regulating Standards Blossoming Beyond Borders Nature s Pharmacy Introduction Ginseng: Root of Immortality Gingko: Total Recall? Snakeroot Plant: The Original Tranquilizer Bacopa: Memory Plus Garlic: The Detoxifier Aswagandha: Root of Rejuvenation St. John s Wort: Prozac of plants Echinacea Neem: Plant of the 21st century Shakespearean Herbs: Food Act Turmeric: Cure with Curry Ephedra: Mormon Tea Chocolate: Divine Treat Beauty Care: Getting Physical The Blenders Choice Herbs are Bioreactors Herbs in Soup: Stirred but not Shaken Quality - Taking Active Measures Standardization: Phases Herbs have to grow Through Good Agricultural Practices: GAP to Bridge Identification and Selection: Born Identity Codex: Phytosanitary Agreement Good Manufacturing Practices Good Laboratory Practices Marking up Herbal Image? USP Verified Preclinical Testing Clinical Trials Industry Money Skews Drug Overviews? Pharmacology: Active Site Model Antioxidants: Radical Thinking Alkaloid for Lowering Cholesterol A New Leaf Free Trade: Test Locally and Trade Globally Introduction ISO and GXP: Global Standard Practices Documentation: Living History Traceability Calibration Certified Reference Materials Validations Method Selection and Validation Measurement Uncertainty Proficiency Testing Clinical Trials Double-Blind Studies The Placebo Effect Statistical Illusions Meta-analysis Mutual Recognition Agreement Free Tree and Intellectual Property Intellectual Property Rights and Wrongs? Patents: Art of the Possible Turmeric: Healing Wounds Neem Campaign Inca: Jungle Treasures Aroma of Basmati Patent Digital Defence: Past Forward Sharing the Wealth ...and Saving Health Pharmers and Farmaceuticals Drug Discovery Process: New Paradigm China: Exporting Success Farming out to CROs Biodiversity: Clear and Present Danger Designs on Nature: Farmaceuticals Herbal Medicines on Tap? Pharmers: Better the Devil you Grow? Viva La Vida: Long Live Life Further Reading Index