Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by balakotu – India, 2019-06-18 13:03 – Posting: # 20333
Views: 748

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:

Dose term in the ANOVA Model balakotu 2019-06-18 13:03 [Regulatives / Guidelines]
- Dose term in the ANOVA Model ElMaestro 2019-06-18 13:14
  - OT: BW in ANCOVA Helmut 2019-06-18 13:39
    - OT: BW in ANCOVA ElMaestro 2019-06-18 15:51
  - Dose term in the ANOVA Model balakotu 2019-06-21 07:31
    - Dose term in the ANOVA Model ElMaestro 2019-06-21 20:54

Bioequivalence and Bioavailability Forum | Admin contact
19,687 posts in 4,178 threads, 1,352 registered users;
online 13 (0 registered, 13 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 21:24 CEST

The fundamental cause of trouble in the world today is
that the stupid are cocksure
while the intelligent are full of doubt. Bertrand Russell

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC

Ing. Helmut Schütz