Bioequivalence and Bioavailability Forum • Dose term in the ANOVA Model

Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2019-06-18 15:14 (1773 d 01:15 ago) – Posting: # 20334
Views: 4,340

Hi balakotu,

❝ 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.

Thanks for highlighting this.
It is a funny, odd wording. 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').

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Pass or fail!
ElMaestro

Complete thread:

Dose term in the ANOVA Model balakotu 2019-06-18 13:03 [Regulatives / Guidelines]
- Dose term in the ANOVA ModelElMaestro 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 Model balakotu 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