Bioequivalence and Bioavailability Forum

Dear All,

Greetings.

Please help to resolve the following queries related to biowaiver application.

1. We are filing an ANDA for BCS class I drug. We have done the studies pertinent to high solubility and rapid dissolution profiling of the drug substance and drug product respectively, but we have not done any permeability studies. So in this regard can we use the permeability data provided by the innovator on the Freedom of information available on US-FDA website and submit a biowaiver application to US-FDA.
2. Is it always necessay to do the dissolution profiling on the exhibit batch only or can it be performed on scale up or pre-exbhibit batch.

Desperately awaiting for your reply in this regards.