Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by balakotu – India, 2019-06-18 11:03  – Posting: # 20333
Views: 596

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,583 posts in 4,155 threads, 1,340 registered users;
online 6 (1 registered, 5 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 04:29 UTC

Mediocrity finds safety in standardization.    Frederick E. Crane

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5