Bioequivalence and Bioavailability Forum

If the reference product does not pass in BCS ?? [Dissolution / BCS / IVIVC]

posted by Mauricio Sampaio  – Brazil, 2018-01-10 14:52 (2656 d 09:32 ago) – Posting: # 18159
Views: 4,294

Hi El Maestro

❝ How about Mahalanobis or Bootstrap?

I understood that Mahalanobis and Bootstrap help to understand how the distance is not always what it seems. But, how these statistical tools could help me, if the reference product does not meets the minimum dissolution requirements to obtain a biowaiver of the test product?

Complete thread:

• If the reference product does not pass in BCS ?? Mauricio Sampaio 2018-01-08 19:59 
  • If the reference product does not pass in BCS ?? ElMaestro 2018-01-09 05:35
    • If the reference product does not pass in BCS ??Mauricio Sampaio 2018-01-10 13:52
  • If the reference product does not pass in BCS ?? Relaxation 2018-01-09 16:20
    • If the reference product does not pass in BCS ?? Mauricio Sampaio 2018-01-10 13:59