Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by balakotu – India, 2019-06-18 13:03 (1157 d 20:28 ago) – Posting: # 20333
Views: 4,231

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:

UA Flag
Activity
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 6 (1 registered, 5 guests [including 3 identified bots]).
Forum time: Friday 09:31 CEST (Europe/Vienna)

Doctors are men who prescribe medicines of which they know little,
to cure diseases of which they know less,
in human beings of whom they know nothing.    Voltaire

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