highly variable drugs-Cmax [Regulatives / Guidelines]

posted by nuka2020 – United Arab Emirates, 2020-11-19 12:09 (1195 d 22:38 ago) – Posting: # 22067
Views: 2,049

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%.
But, i have a study which was performed as per Eu guidelines and accordingly, the acceptance criteria for Cmax can be widened to a maximum of 69.84 – 143.19%. Accordingly, the results of Cmax is: 70.46%-141.90%
Need suggestion whether this studies can be acceptable as per GCC guidelines?? :confused::confused:

Complete thread:

UA Flag
Activity
 Admin contact
22,912 posts in 4,806 threads, 1,636 registered users;
29 visitors (0 registered, 29 guests [including 7 identified bots]).
Forum time: 10:48 CET (Europe/Vienna)

Exploratory analysis: The art of finding a Rembrandt
in a Jackson Pollock.    Stephen Senn

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