Benefit:Risk Analysis
- Early-Stage Research and Development of Drugs and Biologic Products
- •Evaluation of Evidence for the Approval and Sale of Medications
- •Extent of Patient Exposure Prior to Approval and Sale of Prescription Drugs
- •Experimental Research and Observational Research
- •Experimental Research: The Clinical Trial
- •Stages of Clinical Development Prior to FDA Review and Approval
- •Phase I Clinical Research
- •Phase II Clinical Research
- •Phase III Clinical Research
- •Phase IV Clinical Research Following FDA Approval
- •Clinical Research Principles and Limitations
- •Observational Research