Abstract
This is the last in a series of Stimuli articles developed by the USP Expert Panel New Advancements in Product Performance Testing charged with reviewing and proposing new approaches for drug performance testing in the US Pharmacopeia. The USP Expert Panel created working groups that focused on five major routes of administration, continuous manufacturing, and nanomaterials. The article reports the results of the working group that studied the performance tests for orally administered drug products. The goal of this article is to highlight current knowledge gaps and potential challenges associated with performance tests for certain orally administered drug products, and to stimulate public input on current practices and new advances for in vitro testing. The input received may inform the development or revision of USP general chapters.
| Original language | English |
|---|---|
| Pages (from-to) | 110-121 |
| Number of pages | 12 |
| Journal | Dissolution Technologies |
| Volume | 31 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 31 Aug 2024 |
Acknowledgements
The authors are grateful to the following members at the USP EP-NAPPT and the Oral Drug Product Subcommittee on the USP General Chapters Dosage Forms Expert Committee for providing valuable insights, discussions and suggestions to this Stimuli article during review: Gregory Hunter (US FDA Office of Pharmaceutical Quality, Maryland, USA), Susan Cady (CMC Solutions LLC, Yardley, PA, USA), Kevin Warner (Alucent Biomedical, Salt Lake City, 120 AUGUST 2024 Utah, USA), Vivian Gray (V.A. Gray Consulting, Hockessin, DE, USA), Vivek Shah (Sotax Corp, Westborough, MA, USA), Carrie A Coutant (Eli Lilly and Co, Indianapolis, IN, USA), and Sandra Klein (University of Greifswald, Greifswald, Mecklenburg-Vorpommern, GER).ASJC Scopus subject areas
- Pharmaceutical Science