B Pharm Industrial Pharmacy 2 Unit 3 PDF Notes
B Pharm Industrial Pharmacy 2 Unit 3 PDF Notes dives into the fascinating world of Regulatory Affairs, ensuring the safe and effective development of new drugs. Imagine being the gatekeeper, safeguarding public health by ensuring medications meet strict government standards before reaching patients. We'll explore the history of drug regulation, the roles of different regulatory bodies like the FDA and EMA, and the responsibilities of Regulatory Affairs professionals. Buckle up as we delve into the intricate process of drug approval, from pre-clinical testing to clinical trials and beyond. We'll dissect the requirements for Investigational New Drug (IND) applications, understand the importance of data integrity and clinical research protocols, and learn how biostatistics helps analyze clinical trial results. By the end of this unit, you'll appreciate the critical role of Regulatory Affairs in bringing safe and effective medications to the world.
B Pharm Industrial Pharmacy Unit 3 PDF Notes
Unit 3
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals
Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
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