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Our validated 3-step study design allows for early identification of BCS biowaiver candidates and optimization of protocol elements. These steps include:

1. Pre-qualification and determination of the eligibility of test compound for BCS biowaiver. Your go/no-go decision point.
2. Protocol optimization and conduct of FDA-required experiments to establish protocol for pivotal studies.
3. GLP BCS classification of permeability
   and/or solubility.

BCS Biowaivers Background Information
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.

A Decade of BCS History
Absorption Systems has performed dozens of BCS studies over the past ten years, resulting in some of the very first BCS biowaivers granted by the FDA.

Translating Cellular Science into Human Outcomes
The FDA explicitly recommends the BCS approach for many drugs and welcomes data for any qualified candidate. Find out which clinical studies you could potentially waive by using Absorption Systems’ dually validated Caco-2 test system.

Redefining the Threshold for Permeability Classification
The permeability threshold defined by Absorption Systems novel High Permeability Internal Standard is the lowest available, about 7-fold less than metaprolol.

Welcome to the BCS Zone
Watch this video and learn more about BCS biowaivers from our President and CEO, Patrick Dentinger.