Recognize the investigational drug success rates by stages
Define pre-clinical studies
Define Investigational New Drug Application Phase I, II, III Studies
Define New Drug Application
Define phase IV studies
Investigational Drug Success Rates by Stage
Pre-Clinical Studies
Single Dose Toxicity Studies
Repeated Dose Studies
Safety Pharmacology Studies
Genotoxicity Studies
Carcinogenicity Studies
Reproductive Toxicity Studies
Data Collected in Animal Studies
Investigational New Drug Application
The product of successful Preclinical development
If the investigational New Drug submission is accepted, the compound begins Phase I –IV clinical trials. Long-term preclinical trials continue.
Clinical Research
Phase I : First in Humans
Trial Design
Normal, usually healthy, volunteer subjects
Few subjects (20-100)
Typically single center
Usually no benefit to subjects
Duration: Short – from days to several weeks or months