The FDA’s Biopharmaceutics Classification System(BCS). However, at this time only BCS Class 1 drugs are eligible for a biowaiver of in vivo bioequivalence from the FDA 1 and BCS Class 1 as well as some Class 3 drugs by the EMA 9.

1. Bcs Class Iii Biowaiver

Introduction The International Conference on Harmonization (ICH) M9: Biopharmaceutics Classification System-based Biowaivers, 1,2 was adopted in mid-June 2016. A biowaiver allows for in vitro testing to be used in lieu of in vivo bioavailability and/or bioequivalence studies to facilitate product approval, where solubility and permeability are not expected to impede bioavailability. ICH M9 will therefore minimize unnecessary in vivo studies in man and allow greater public access to vital medicines. However, this approach is not always universally aligned or recognized.

Bcs Class Iii Biowaiver

The Role of Biowaivers In certain cases regulatory applications using biowaivers are permissible. Submissions can be either based on BCS, in vitro - in vivo correlation (IVIVC), in vitro - in vivo relationship (IVIVR) or simply on an in vitro dissolution profile comparison. Examples of the BCS, IVIVC or IVIVR biowaiver approach 3 include: • in support of generic product entry versus the innovator product • in support of regulatory submission, i.e. Changing the product type during development (capsules to tablets, etc.) • in support of over-encapsulated comparator products, that are often used in pivotal clinical studies • in support of bridging between the product used in pivotal clinical studies and the ‘to be marketed’ commercial product • in support of product line extensions (PLEs) for different clinical populations, i.e.