long half-life and large variability [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-08-12 15:53 (406 d 11:55 ago) – Posting: # 21865
Views: 1,184

Hi Achievwin,

» Welcome to the home of funky and funny pharmacokinetics where "Garbage in Gospel out" is day of life.

:-D

» 1. allowing long washout periods have seen studies with 4 -5 months washout.

Seen a couple as well.

» 2. other choice we can imagine is Two stage adaptive study design and including ANCOA in place of ANOVA...

Slippery grounds – nothing published. You are on your own to demonstrate that the Type I Error is controlled. For the FDA and Health Canada likely simulations are sufficient. For the EMA no way.
I’m a fan of TSDs but if you proceed to the second stage it more than doubles the time of study compared to a fixed sample design. With fast to moderate half lives not an issue. But here?

Furthermore, reference-scaling for HVD(P)s in a TSD is not possible. Some tried, all studies were rejected due to potential inflation of the TIE.

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
21,691 posts in 4,534 threads, 1,541 registered users;
online 2 (0 registered, 2 guests [including 1 identified bots]).
Forum time: Thursday 03:49 CEST (Europe/Vienna)

Learning is a lifetime process, but there comes a time
when we must stop adding and start updating.    Robert Brault

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