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

posted by jag009  – NJ, 2019-12-18 03:45  – Posting: # 20989
Views: 831

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:

Activity
 Admin contact
20,798 posts in 4,354 threads, 1,445 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time: 23:44 UTC (Europe/Vienna)

If a man will begin with certainties, he will end in doubts;
but if he will be content to begin with doubts,
he will end in certainties.    Francis Bacon

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