Bioequivalence and Bioavailability Forum • biowaiver for higher strength

biowaiver for higher strength [Regulatives / Guidelines]

posted by wienui – Germany/Oman, 2022-02-01 10:12 (808 d 17:02 ago) – Posting: # 22768
Views: 2,123
(edited by wienui on 2022-02-01 15:29)

Hi John,

❝ Based on the above, can I file a biowaiver for the higher strength test product so I don't have to run a PK BE study?

Are both strengths (low & high) follow the following EMA 5% & exceients rule?

EMA :
Amount of API must be < 5% of tablet core weight, and
Amounts of excipients are same per strength, or
Only the amount of a filler is changed to account for changes in API weight.

—
Cheers,
Osama

Complete thread:

biowaiver for higher strength jag009 2022-01-24 07:48
- biowaiver for higher strength dshah 2022-01-24 11:01
  - biowaiver for higher strength jag009 2022-01-24 15:09
    - biowaiver for higher strength dshah 2022-01-24 20:18
    - biowaiver for higher strength dshah 2022-02-03 19:07
- Linearity Ohlbe 2022-01-24 12:16
  - Linearity jag009 2022-01-24 15:06
- biowaiver for higher strengthwienui 2022-02-01 09:12