Pharmacology - Developmental Stages

  1. Stage 1 - Preclinical Research & Development
    • -Begins with discovery, synthesis, and purification
    • -Studies done to see if substances had therapeutic value & safe
    • -IND application submitted
  2. Stage 2 - Clinical Research & Development
    • Human Testing
    • -determine metabolic & biological effects, safety, dose
    • -evaluate effectiveness and side effects
    • -verify effectiveness & monitor adverse effects for long term use
  3. Stage 3 - New Drug Application Review
    NDA submitted to FDA requesting permission to market for use
  4. Stage 4 - Post-Market Surveillance
    • Manufacturing starts marketing the drug
    • Dosage recommendations are defined
Author
msierak
ID
210967
Card Set
Pharmacology - Developmental Stages
Description
N126
Updated