Toward a generic approach for: Stress testing of drug substances and drug products
Toward a generic approach for: Stress testing of drug substances and drug products
About this item
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Author / Creator
Publisher
Duluth, MN: Advanstar Communications
Journal title
Language
English
Publication information
Publisher
Duluth, MN: Advanstar Communications
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Scope and Contents
Contents
Stress testing is defined as the stability testing of drug substances and drug products under conditions exceeding those used for accelerated testing. According to various regulatory guidance documents, results from stress testing should be included in the dossier when a registration application is submitted to regulatory authorities. This article...
Alternative Titles
Full title
Toward a generic approach for: Stress testing of drug substances and drug products
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Record Identifier
TN_cdi_proquest_reports_198157566
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_reports_198157566
Other Identifiers
ISSN
1543-2521
E-ISSN
2150-7376
