The PQRI BTC Working Groups (WGs) deal with regulatory and scientific issues associated with the following areas of biopharmaceutics:
The Sequential Design WG is developing appropriate statistical methods to justify the approach of using sequential design methods to permit the pooling of pharmacokinetic data from multiple studies to justify a bioequivalance of a product.
Dissolution WG is considering a core set of dissolution methods that would be applied to all products to aid in the identification of a dissolution method that is predictive of in vivo behavior for a given compound.
BCS Class III Biowaiver WG is collecting and analyzing data to determine the viability of biowaivers for BCS Class III compounds.
