Tricky… [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-01-30 20:18 (1992 d 12:08 ago) – Posting: # 21112
Views: 27,411

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,436 posts in 4,932 threads, 1,677 registered users;
55 visitors (1 registered, 54 guests [including 14 identified bots]).
Forum time: 09:27 CEST (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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