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Zustand: New.

Zustand: New.

Zustand: New.

Soft cover. Zustand: New. Contents: Section 1: Herbal Products and Regulations 1. Overview on Herbal Product Regulations: Challenges and Solution Section 2: Herbs and Derived Products 2. Extraction, Purification, Preliminary Phytochemical Screening and Structural Elucidation of Natural Products 3. Herbal Formulations: Traditional, Conventional and NDDS 4. Herbal Cosmetics and Regulations 5. Nutraceuticals and Regulations 6. Labeling and Packaging of Herbal Products Section 3: Traditional Medicines Regulations 7. Indian Systems of Medicines, Regulations and Related Guidelines 8. WHO - General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine 2000 9. Drug & Cosmetic Act, 1940-Schedule T Good Manufacturing Practice of Indian Systems of Medicine Section 4: Quality Control, Standardisation, Regulations for Herbal Products 10. WHO Good Agricultural and Collection Practices [GAP, GCP, GACP] 2003 11. NMPB Guidelines and Standard for Good Field Collection Practices for Medicinal Plants 2009 12. WHO Guidelines on Good Herbal Processing Practice for Herbal Medicine 2018 13. WHO Guidelines on Good Storage and Distribution Practices 2019 14. Herbal Monograph, Pharmacopoeias, Markers 15. WHO Guidelines for Selecting Marker Substances of Herbal Origin for Quality Control of Herbal Medicines 2017 16. WHO and ICH Guidelines for Quality Control of Herbal Materials 17. Stability Testing and Shelf Life Determination of Herbal Medicines Section 5: Pre-clinical and Toxicity Regulations for Herbal Products 18. CPCSEA and OECD Guidelines for Animal Experimentation 19. Human Dose Calculation Guidelines 20. WHO Guidelines for Assessment, Evaluation of Toxicity, Safety and Efficacy of Herbal Medicines 2000 21. AYUSH General Guidelines for Safety/Toxicity Evaluation of Ayurvedic Formulations 2018 Section 6: Pharmacovigilance and Clinical Trial Regulations for Herbal Products 22. WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems 2004 23. Fundamentals of Clinical Trails and Phases of Trials 24. AYUSH Guidelines of Good Clinical Practices 2018 25. CDSCO Guidelines of Good Clinical Practices 2013 26. Ethical Principles for Clinical Trials 27. ICH Guidelines for Good Clinical Practices 2016 Section 7: Herbal Industry, IPR and Regulatory Affairs 28. Herbal Industry: Infrastructure, Formulation, Production and Pilot Plant Scale-Up Management of Herbal Products 29. Herbal Entrepreneurship 30. Herbal Raw Material Trade 31. GMP, GLP, TQM and ISO for Herbal Medicines 32. Intellectual Property Rights and Herbal Products 33. Geographical Indications of Goods (Registration and Protection) Act, 1999 34. New Drug Application: NDA, INDA, ANDA, BLA, OTC 35. Master Formula, SMF-Site Master File, DMF-Drug Master File, Dossier and CTD, Chemistry Manufacturing & Controls (CMC) Dossier "Quality Control of herbal Drugs: Standardisation and Regulations" offers a comprehensive guide to navigating the complexities of this industry. This book answers a multitude of important questions, such as: What are the different categories of herbal products? How do traditional AYUSH products differ from modern herbal products? What are the guidelines and regulations concerning the quality, safety, toxicity, and efficacy of AYUSH products, herbal drugs, and derived products? Furthermore, the book explores the process of standardizing herbal products, outlining the requirements for establishing a successful herbal industry. It also delves into the necessity of conducting preclinical and clinical studies for herbal products, shedding light on the importance of evidence-based practices. "Quality Control of herbal Drugs: Standardisation and Regulations" provide practical insights into herbal entrepreneurship, but it also explores how herbal products are regulated in various countries. With the inclusion of QR codes after each chapter, readers can easily access additional supportive knowledge to enrich their understanding of the subject.