Tricky… [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-01-30 19:18 2a02:8388:6bc2:ce80:59da:2536:a4ac:85cd – Posting: # 21112
Views: 4,390

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:

Cheers,
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
20,345 posts in 4,273 threads, 1,402 registered users;
online 4 (0 registered, 4 guests [including 1 identified bots]).
Forum time (Europe/Vienna): 08:18 CET

No one wants to learn from mistakes, but we cannot learn enough
from successes to go beyond the state of the art.    Henry Petroski

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