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

posted by Helmut Homepage – Vienna, Austria, 2020-11-19 12:05 (8 d 02:29 ago) – Posting: # 22068
Views: 294

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 🖖
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
21,214 posts in 4,427 threads, 1,481 registered users;
online 12 (0 registered, 12 guests [including 9 identified bots]).
Forum time: Friday 14:34 CET (Europe/Vienna)

Biostatistician. One who has neither the intellect for mathematics
nor the commitment for medicine but likes to dabble in both.    Stephen Senn

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