Bioequivalence and Bioavailability Forum • Dose term in the ANOVA Model

Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by balakotu – India, 2019-06-21 09:31 (1770 d 02:36 ago) – Posting: # 20354
Views: 4,216

❝ ❝ As per the FDA guidance of Sapropterin Dihydrochloride Tablets, The total dose should be included in the ANOVA model.

❝

❝ I believe they meant to do an ANCOVA with total dose as covariate.

❝ Your (fixed) factors would be subject, sequence, period, treatment. Note that even with the bogus random statement in SAS when using PROC GLM the model is fit with a single random term (the 'error').

Dear ElMaestro,

Thaks for your response.

When i keep totaldose is a factor along with normal fixed effects (seq sub(seq) per trt) the model is not execute, Please let us know what are the fixed effects is required in ANOVA model.

SAS code:

model Cmax AUCt AUCi= seq sub(seq) per trt totaldose / ss3;

test h= seq e=sub(seq)/htype=3 etype=3;

Regards
Kotu.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [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
    - OT: BW in ANCOVA Kumarnaidu2 2021-03-05 14:56
  - Dose term in the ANOVA Modelbalakotu 2019-06-21 07:31
    - Dose term in the ANOVA Model ElMaestro 2019-06-21 20:54
      - Dose term in the ANOVA Model d_labes 2021-03-06 15:22