Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by vandee – Malaysia, 2020-11-23 06:52 (545 d 02:43 ago) – Posting: # 22076
Views: 1,474

Dear All,

I'd like to seek some advice regarding a specific requirement in the EMA BE guidelines biowaiver:

the amount of the active substance(s) is less than 5 % of the tablet core weight, the weight of the capsule content

Is this criteria applicable for both the BE strength and the lower strength aimed for biowaiver? 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. All other biowaiver requirements have been met.

Appreciate any advise i can get on this matter. Thank you very much

Complete thread:

UA Flag
Activity
 Admin contact
22,091 posts in 4,630 threads, 1,566 registered users;
online 11 (0 registered, 11 guests [including 8 identified bots]).
Forum time: Sunday 10:36 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5