Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by vandee – Malaysia, 2020-11-23 06:52 (375 d 05:08 ago) – Posting: # 22076
Views: 1,343

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:

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 10 (1 registered, 9 guests [including 7 identified bots]).
Forum time: Friday 12:01 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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