• Biopharmaceutical Classification System

Current version For public consultation Reference number EMA///4 Published Start of consultation End of consultation Keywords study exemptions, solubility, permeability, in vitro dissolution Description This new multidisciplinary is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. Is live updater safe.

This means that pharmaceutical companies have to follow different approaches in the different regions. This will provide recommendations to support the biopharmaceutics classification of and will provide recommendations to support the waiver of studies. This will result in the harmonisation of current regional /guidance and support streamlined global drug development.

Biopharmaceutical Classification System

The increasing number of new chemical entities is bringing new challenges to the field of drug delivery. These drugs present bioavailability issues that are frequently associated with intestinal metabolism or efflux mechanisms. Some excipients, particularly surfactants, have demonstrated a capacity to interfere with these mechanisms, improving drug bioavailability. Consequently, these excipients can no longer be considered as inert and should be subject to special considerations from a regulatory perspective. In the present manuscript, the state-of-the-art research related to these abilities of excipients to interfere with intestinal metabolism and efflux mechanisms are presented and discussed. Here, a biopharmaceutical classification system of excipients is proposed for the first time as a tool in the development of new products and for regulatory purposes.