And Japan? [BE/BA News]

posted by ElMaestro  – Denmark, 2019-12-04 15:43 (2035 d 23:05 ago) – Posting: # 20923
Views: 8,151

Wow,

❝ A: The guideline focuses on BCS-based biowaiver principles to be applied for bioequivalence purposes provided they are supported by a sound scientific rationale. The provision in the guideline that accommodates exceptions to existing regulations that do not permit BCS-based biowaivers for generic product applications, at this time, does not disqualify implementation of these harmonized technical requirements to demonstrate BCS based biowaivers for other product applications unless explicitly stated.


I tried to read that answer 10 times now and I am none the wiser. Do they mean "The guideline will deal with BCS-based biowaivers, but it is acknowledged that some countries might not accept those." ??
:-)

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,679 registered users;
60 visitors (0 registered, 60 guests [including 8 identified bots]).
Forum time: 15:49 CEST (Europe/Vienna)

Fools with Tools Are Still Fools!    Anonymous

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