Biopharmaceutics Classification

Absorption Systems Does More In Vitro BCS Biowaiver Studies Than Anyone Else in the World.

The Biopharmaceutics Classification System (BCS) remains underutilized in drug development. It is an regulatory pathway through which, in some cases, a drug developer can avoid clinical bioequivalence studies based solely on in vitro solubility, permeability, and dissolution data. It can save significant time and money in drug development, and is endorsed by the World Health Organization as a way of making generic drugs more readily available to poor countries. The most obvious application is for generics, and it is used frequently in that context, but it also applies to new drugs.

We have a wealth of information regarding BCS classification and biowaivers:
Learn more about BCS tools and methods
Learn more about BCS regulatory guidance
Learn more about BCS Classification
Learn more about BCS Biowaivers
Learn more about our permeability threshold for BCS

Assays
Preliminary BCS Solubility Classification by Shake Flask 
GLP BCS Solubility Classification by Shake Flask 
Preliminary BCS Permeability Classification using Caco-2 Cell Monolayers 
GLP BCS Permeability Classification using Caco-2 Cell Monolayers