In-Vitro Product Performance of Parenteral Drug Products: View of the USP Expert Panel
Citation:
Deirdre M. D?Arcy, Matthias G. Wacker, Sandra Klein, Vivek Shah, Matthew D. Burke, Gregory Hunter, and Hao Xu, In-Vitro Product Performance of Parenteral Drug Products: View of the USP Expert Panel, Dissolution Technologies, Nov, 2022, 204 - 218Download Item:
Abstract:
Performance testing of parenteral products represents a broad arena of product types, test equipment, and analytical
challenges. This Stimuli article is one in a series of Stimuli articles on product performance testing focused on common
methodological approaches used and challenges encountered in the field of performance testing of injectable products.
The article is complementary to In Vitro Release Test Methods for Parenteral Drug Preparations <1001> and takes
into account the contents and acknowledges current trends in test apparatus and conditions, medium selection, and
separation techniques. Limitations of current practices are presented, and recommendations highlight the need for
biorelevant and predictive test environments, test standardization, and an understanding of the impact of the test
conditions on the release kinetics and interpretation of test results
Author's Homepage:
http://people.tcd.ie/ddarcy
Author: D'Arcy, Deirdre
Type of material:
Journal ArticleSeries/Report no:
Dissolution Technologies;Nov;
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Full text availableSubject (TCD):
Immunology, Inflammation & Infection , Nanoscience & Materials , DISSOLUTION TESTINGDOI:
dx.doi.org/10.14227/DT290422P204Metadata
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