Regulatory Challenges: PAT Applications in NDAs

6/14/02


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Table of Contents

Regulatory Challenges: PAT Applications in NDAs

New NDA - Balance of Goals

New NDA - Balance of Goals

PAT - New Program Opportunities

PAT - New Program Challenges

PAT - Filing Challenges

PAT - NDA Filing Options

PAT - NDA Protocols

PAT - NDA Protocols

PAT - New Programs: Summary

Author: BlumensteinJ