Bioequivalence and Bioavailability Forum • Dose term in the ANOVA Model

Dose term in the ANOVA Model [Regulatives / Guidelines]

posted by balakotu – India, 2019-06-18 15:03 (1627 d 12:31 ago) – Posting: # 20333
Views: 4,569

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 Modelbalakotu 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 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