Tricky… [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-01-30 19:18 (719 d 14:20 ago) – Posting: # 21112
Views: 17,043

Salam Osama,

» » […] with fixed (!) limits of 75.00–133.33% if CVwR <30%.
»
» I think there is a mistake here, you are right according to the fixed limit of 75-133% in the GCC Guidelines in the case of HVD (HVDP) which is absolutely not correct and cause a lot of problems in the evaluation of such drug formulation's types, BUT widen to this range is not in the case of ABE and not at all if CVwR <30% .

Of course, of course! Sorry, it was a stupid typing error. :angry:

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,831 posts in 4,567 threads, 1,553 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Wednesday 09:39 CET (Europe/Vienna)

Research under a paradigm must be a particularly effective way
of inducing paradigm change.    Thomas S. Kuhn

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