Bioequivalence and Bioavailability Forum

Biowaiver criteria - 5% [Regulatives / Guidelines]

posted by Laura Carreiras – Portugal, 2022-08-12 14:03 (220 d 14:18 ago) – Posting: # 23218
Views: 1,127

Hello everyone!


As described in the bioequivalence guideline:



I would like to know if anyone has experience with a similar situation. If the active substance is equal to 5.00% of the tablet core weight, can it be considered proportional?

Thank you in advance for the help.

Complete thread:

• Biowaiver criteria - 5%Laura Carreiras 2022-08-12 12:03 
  • Biowaiver criterion <5% (not ≤5%) Helmut 2022-08-12 12:17
    • Biowaiver criterion <5% (not ≤5%) Laura Carreiras 2022-08-12 12:37
      • Biowaiver criterion <5% (not ≤5%) wienui 2022-08-16 18:22