Bioequivalence and Bioavailability Forum • Biowaiver for Lower Strength

Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-11-23 11:41 (1606 d 20:10 ago) – Posting: # 22077
Views: 2,911

Dear vandee,

❝ Can a BE biowaiver for the lower strength be considered if only the lower strength meets this <5% API of tablet core weight requirement? The higher strength has 5.88% of API content per tablet core weight and passed BE.

The 5% criterion applies to both strengths, lower and higher.

—
Regards
Ohlbe

Complete thread:

Biowaiver for Lower Strength vandee 2020-11-23 06:52 [Regulatives / Guidelines]
- Biowaiver for Lower StrengthOhlbe 2020-11-23 10:41
  - Biowaiver for Lower Strength vandee 2020-11-25 06:17
- Biowaiver for Lower Strength wienui 2020-11-24 10:42
  - Biowaiver for Lower Strength vandee 2020-11-25 06:21