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![]() ![]() Feb 4, 2010 - The Biopharmaceutics Classification System (BCS) is a scientific framework for classifying drug substances based on their aqueous solubility. Biopharmaceutical Classification System PdfBiopharmaceutics 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. Biopharmaceutical Classification System Of DrugsFor 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. 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. It was our permeability data that supported some of the very first in vitro BCS biowaivers. ![]() Our extensive experience continues to facilitate innovative solutions and enable in vitro classification for a broader range of drugs. This, combined with our 10-day turnaround for pre-qualification and our cost effective designs, saves you time and money. Bcs Class 2 Drugs ListJust a few reasons why Absorption Systems averages more than 30 BCS studies each year. Contents • • • • • • BCS classes [ ] According to the Biopharmaceutical Classification System (BCS) drug substances are classified to four classes upon their solubility and permeability: • Class I - high, high • Example: • Those compounds are well absorbed and their absorption rate is usually higher than excretion. • Class II - high permeability, low solubility • Example:,,, paracetamol, • The of those products is limited by their solvation rate. Biopharmaceutical Classification Of DrugsA correlation between the bioavailability and the solvation can be found. • Class III - low permeability, high solubility • Example: • The absorption is limited by the permeation rate but the drug is solvated very fast. If the formulation does not change the permeability or gastro-intestinal duration time, then class I criteria can be applied. • Class IV - low permeability, low solubility • Example: • Those compounds have a poor bioavailability. Usually they are not well absorbed over the intestinal mucosa and a high variability is expected.
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