Introduction to  Drug Development Process 

Objectives

• 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
• Open label – no placebo or comparative agent
• Uncontrolled
• Single or multiple doses