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Pharmacology - Developmental Stages
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Stage 1 - Preclinical Research & Development
-Begins with discovery, synthesis, and purification
-Studies done to see if substances had therapeutic value & safe
-IND application submitted
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
Stage 3 - New Drug Application Review
NDA submitted to FDA requesting permission to market for use
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
2013-04-02T17:50:39Z
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