Industrial Pharmacy II Notes [U-3]
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Regulatory Affair Notes
- Introduction to Regulatory Affairs
- Historical Overview of Regulatory Affairs
- Regulatory Authorities in Industrial Pharmacy
- 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
- Toxicology
- General Considerations for an Investigational New Drug (IND) Application
- Investigator’s Brochure (IB)
- New Drug Application (NDA)
- Clinical Research in Drug Development
- Bioequivalence (BE) Studies
- Clinical Research Protocols
- Biostatistics in Pharmaceutical Product Development
- Data Presentation for FDA Submissions
- Management of Clinical Studies
