Pharmacology - Developmental Stages

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Author:
msierak
ID:
210967
Filename:
Pharmacology - Developmental Stages
Updated:
2013-04-02 13:50:39
Tags:
Test
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Description:
N126
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  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

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