Fda Bcs
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Biopharmaceutics Classification System. To discuss an alternative approach, contact the FDA office responsible for th is guidance as listed on the title page. The Biopharmaceutics Classification System is a system to differentiate the drugs on the basis of their solubility and permeability. [1] This system restricts the prediction using the parameters solubility and intestinal permeability.
Biopharmaceutics 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. According to the 2000 FDA BCS Guidance, compounds that are classified as Class I (highly soluble, highly permeable) are eligible for BCS biowaivers. 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. Furthermore, for Class I compounds, it is unlikely that absorption will be limited by efflux transporters.
Fda Bcs Guidance
Bcs Class
Thus, it may be possible to waive clinical DDI studies as well. “If in vitro experiments demonstrate that an NME is a P-gp substrate, additional drug-specific factors may be considered before determining whether an in vivo drug interaction study is warranted. For example, the bioavailability of the BCS Class I or BDDCS Class I NMEs that are highly soluble, highly permeable, and highly metabolized may not be significantly affected by a co-administered drug that is a P-gp inhibitor, and thus, an in vivo interaction study may not be needed.” — L. Zhang et al., “Predicting Drug-Drug Interactions: An FDA Perspective” (2009) The AAPS Journal Absorption Systems, World Leader in Biopharmaceutics Classification System Absorption Systems has performed dozens of BCS classification studies over the past ten years, many of which have resulted in successful BCS biowaiver submissions. Eight of the ten largest generic drug companies have conducted in vitro BCS biowaiver studies with Absorption Systems.