The Use of Systemically Absorbed Drugs to Explore An In Vitro Bioequivalence Approach For Comparing Non-Systemically Absorbed Active Pharmaceutical Ingredients in Drug Products For Use in Dogs
The finding of an inconsistent in vivo/in vitro relationship confirmed that in vitro dissolution alone cannot assure product BE for veterinary locally acting GI products. However, when combined with a comparison of product composition and manufacturing method, this totality of evidence approach can successfully alert scientists to potential therapeutic inequivalence, thereby supporting FDA's efforts to Replace, Reduce, and/or Refine terminal animal studies.
Authors
- Ahmed S. Ibrahim (ORCID: https://orcid.org/0000-0002-6206-6625)
- Linge Li (ORCID: https://orcid.org/0000-0001-9907-5229)
- David Longstaff
- Raafat Fahmy (ORCID: https://orcid.org/0000-0002-3105-404X)
- Shasha Gao
- Marilyn N. Martinez (ORCID: https://orcid.org/0000-0002-4512-853X)
- Michael J. Myers (ORCID: https://orcid.org/0000-0002-7729-6028)
- Kithsiri Herath
- Stephen W. Hoag (ORCID: https://orcid.org/0000-0003-0657-6951)
- R. Gary Hollenbeck
Institutions
- University of Maryland, Baltimore (US)
- Center for Veterinary Medicine (US)
- University of Baltimore (US)
Publication Details
- Journal
- Pharmaceutical Research
- Published
- 2024-09-01
- DOI
- https://doi.org/10.1007/s11095-024-03766-3
- Citations
- 5
- Primary Topic
- Drug Solubulity and Delivery Systems
- Type
- article
- Field-Weighted Citation Impact
- 1.04
Funders
- U.S. Food and Drug Administration