jag009
★★★

NJ,
2019-12-18 04:45

Posting: # 20989
Views: 823
 

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

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
Activity
 Admin contact
20,777 posts in 4,351 threads, 1,444 registered users;
online 13 (0 registered, 13 guests [including 11 identified bots]).
Forum time: 07:06 CEST (Europe/Vienna)

All we know about the world teaches us that the effects of A and B
are always different—in some decimal place—for any A and B.
Thus asking “are the effects different?” is foolish.    John W. Tukey

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