Bioequivalence and Bioavailability Forum • OT: BW in ANCOVA

OT: BW in ANCOVA [Regulatives / Guidelines]

posted by Kumarnaidu2 – India, 2021-03-05 15:56 (1146 d 18:09 ago) – Posting: # 22247
Views: 2,399

Dear All,
I have one query, In PK bio-similarity study in healthy volunteer if the recommended dose is as per bodyweight (say 5mg/kg) then in this case subject with higher bodyweight will receive more total dose as compared to the subject with lower bodyweight. Will this going to impact the serum drug level? If yes then what corrections we need to apply?

Thanks in advance

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 ANCOVAKumarnaidu2 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