Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by balakotu – India, 2019-06-18 13:03 (775 d 10:21 ago) – Posting: # 20333
Views: 3,188

Dear All,

As per the FDA guidance of Sapropterin Dihydrochloride Tablets, The total dose should be included in the ANOVA model. Please any one suggest the terms should be consider in the ANOVA model, since it is a cross over study.

Regards
Kotu


Edit: Guidance linked; see also this post #3[Helmut]

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Sunday 23:24 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

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