FDA药物审批流程

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