![]() ![]() For such compounds, the rate and extent of drug absorption is unlikely to be affected by drug dissolution and/or GI residence time, and in vivo bioequivalence studies (for new formulations, etc.) may be waived based on in vitro permeability and solubility data.īCS Divides Compounds into Four Categories:Ĭlass I – High Solubility, High PermeabilityĬlass II – Low Solubility, High PermeabilityĬlass III – High Solubility, Low PermeabilityĬlass IV – Low Solubility, Low Permeabilityįurthermore, for Class I compounds, it is unlikely that absorption will be limited by efflux transporters. According to the 2000 FDA BCS Guidance, compounds that are classified as Class I (highly soluble, highly permeable) are eligible for BCS biowaivers. Preclinical Toxicology Testing Servicesīiopharmaceutics Classification System (BCS) is a regulatory mechanism through which drug developers and generic companies can obtain a waiver of clinical bioequivalence studies, also called a biowaiver.Physicochemical Properties/Dose Selection.In Vitro Dissolution Absorption System (IDAS).Bioequivalence Testing (BCS, IVRT/IVPT). ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |