biowaiver requirement for APAC (Asia Pacific) [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-12-18 04:45 (887 d 14:53 ago) – Posting: # 20989
Views: 1,249

Hi,

Does anyone know of the biowaiver requirements for APAC (Asia pacific) submission? Specifically, a biowaiver for oral solution (a site change waiver). Is it similar to the requirements for USA and EMA (I think so right but would like to get your feedback).

thx
J

Complete thread:

UA Flag
Activity
 Admin contact
22,092 posts in 4,630 threads, 1,567 registered users;
online 14 (0 registered, 14 guests [including 9 identified bots]).
Forum time: Monday 20:38 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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