DevelopmentClinical Phases
FDA Drug Approval Workflow
-Primary rationale: Quality of Life; Marketing; FDA requested; pharmacoeconomics-After FDA approval of the drug-Often referred to as Marketing or Safety trials-Larger than phase I-III-Less control in terms of regulatory compliance
Ph2
Post-Approval
Discovery
Ph4
Basic Research
Additional data supports
IND Application
Pre-Clinical
NDA Application
Theoretical and paper based
Year 10
Ph3
Trials run here known as post-marketing
Year 5
XY AIMED
With favorable result
Ph1
-Primary rationale: Confirm safety and efficacy profile from phase 2 (success rate: ~25%)-200-1000+ patient volunteers-Mostly looking at long and short term side effects-Suitability of Dosage-3+ years in duration-Favorable Results -- NDA filed with FDA
Sales
Success
Year 0
FDA Approval
-Same as Phase 3 except to gather publishable data and enhance product visibility-'B' phases usually requested by the FDA for additional data to support the endpoints
-Safety profile in laboratory and animal tests (toxicology)?-Biological activity of the drug (Pharmacodynamics)?-Extension and duration of the compound's activity (Pharmacokinetics)?-Typical time frame is 3.5 – 4 years-Favorable Results -- IND filed with FDA
Ph3b
Drug Marketing
