Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by vandee – Malaysia, 2020-11-23 07:52 (1688 d 01:19 ago) – Posting: # 22076
Views: 3,728

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
23,428 posts in 4,929 threads, 1,690 registered users;
103 visitors (0 registered, 103 guests [including 16 identified bots]).
Forum time: 10:11 CEST (Europe/Vienna)

Anyone who conducts an argument by appealing to authority
is not using his intelligence;
he is just using his memory.    Leonardo da Vinci

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