GCC: HV Cmax (fixed limits) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-11-19 13:05 (1215 d 18:27 ago) – Posting: # 22068
Views: 1,828

Hi nuka2020,

❝ According to the GCC guidelines a wider range of Cmax(i.e 75-133%) can be acceptable for HVDP, where it has been demonstrated that the within- subject variability for Cmax of the reference compound in the study is >30%.

❝ … the results of Cmax is: 70.46%-141.90%

❝ Need suggestion whether this studies can be acceptable as per GCC guidelines??


What do you think?
Though you have practically a perfect PE (99.99%) you failed to show BE by far. For the GCC your study was just underpowered.

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
22,940 posts in 4,812 threads, 1,640 registered users;
43 visitors (0 registered, 43 guests [including 4 identified bots]).
Forum time: 07:33 CET (Europe/Vienna)

Those people who think they know everything
are a great annoyance to those of us who do.    Isaac Asimov

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