Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1 [Hardcover]

Chapter 1: Process of Drug Discovery

Chapter 2: History of Drug Regulatory Authorities

Chapter 3: Regulatory of Herbal and Ayurvedic Drug in the context of AYUSH and DCGI

Chapter 4: Traditional medicine (TM)- Regulatory Requirement

Chapter 5: Enforcement of Drug & Cosmetics Act, 1940 to Ayurvedic and Unani Drugs in India

Chapter 6: Ayurvedic Drugs Regulation in India

Chapter 7: Licensing procedure of Indian System of medicine (Ayurveda, Unani, Siddha and Homoeopathy Drugs)

Chapter 8: Regulatory Approval Process of Phytopharmaceuticals, Herbal Drugs or Isolated Compounds from plants or New Claim other than AYUSH Drugs

Chapter 9: Safety and toxicity of Ayurveda, Siddha and Unani (ASU) drugs

Chapter 10: The embarking of Food Safety and Standards Authority of India (FSSAI) and implantation of Food Safety and Standards Act

Chapter-11: Herbal as food vs Drugs: Regulatory framework

Chapter 12: Regulatory Approval and Commercialization process herbal as Insecticide

Chapter 13: Safety studies or pre-clinical toxicity of Modern Medicine

Chapter 14: Clinical trial procedures including the modern medicine and ayurvedic therapies

Chapter 15: Stability Testing of Drugs

Chapter 16: Regulation of Clinical Trial and Role of Institutional Human Ethical Committee

The present volume, Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1, discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (US FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). Many researchers either abandon their work lƒ2