Carewell Pharma

Loading

Industrial Pharmacy 2 - Unit 3

Syllabus

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.


PDF PREVIEW
Unit 3, Industrial Pharmacy 2, B Pharmacy 7th Sem, Carewell Pharma
Download PDF