INDUSTRIAL PHARMACY-II unit-3rd handwritten notes |7th Semester|
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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Index
- 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
