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Biowaiver criteria - 5% [Regulatives / Guidelines]

posted by Laura Carreiras – Portugal, 2022-08-12 14:03 (1063 d 02:01 ago) – Posting: # 23218
Views: 4,682

Hello everyone!

As described in the bioequivalence guideline:

[image]

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 [Regulatives / Guidelines]
- 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

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