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QARA 5545

Post Approval Changes (PAC)

Temple University 3 credits QARA

Course Description

This course reviews SUPAC guidelines developed by CDER to maintain product safety, efficacy, and quality while giving manufacturers substantial regulatory relief and flexibility. A basic review of formulation development of various dosage forms provides a complete understanding of the guidelines and of regulatory strategies for formulation development.

Code
QARA 5545
Credits
3
Subject
QARA

Programs That Include This Course

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