Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products

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February 2, 2005

Pharmaceutical Technology

Pharmaceutical Technology-02-02-2005

Volume29

Issue 2

Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products

The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.

External Link - article-146294.pdf

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Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products

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Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products

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