Pharmacology - Developmental Stages

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

210967

Card Set

Pharmacology - Developmental Stages

Description

N126

Updated

2013-04-02T17:50:39Z

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