Toward a generic approach for: Stress testing of drug substances and drug products

Silke Klick*, Pim G. Muijselaar, Joop Waterval, Thomas Eichinger, Christian Korn, Thijs K. Gerding, Alexander J. Debets, Cari Sänger-Van De Griend, Cas Van Den Beld, Govert W. Somsen, Gerhardus J. De Jong

*Corresponding author for this work

Research output: Contribution to JournalReview articleAcademicpeer-review

Abstract

The Impurity Profiling Group has developed a generic approach for conducting stress testing on drug substances and drug products. The proposed strategy is evaluated and verified with historical data and new experiments. Results demonstrate that the proposed approach is reasonable and generates relevant, generally predictive results for the development of a stability-indicating method.

Original languageEnglish
Pages (from-to)48-66
Number of pages19
JournalPharmaceutical Technology
Volume29
Issue number2
Publication statusPublished - Feb 2005

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