Bioequivalence and Bioavailability Forum • administered dose for drugs dosed per kg body weight

administered dose for drugs dosed per kg body weight [Design Issues]

posted by ElMaestro – Denmark, 2014-08-07 17:01 (4337 d 07:46 ago) – Posting: # 13348
Views: 9,590

Hi BarbaraM,

❝ how should the healthy subjects be dosed in a BE study? should they be dosed by taking into account their body weight (as above) or regardless of their body weight take the 1000 mg tab?

As far as I know in practice this should give the same evaluation so it is your choice unless there is a product-specific guidance or safety concerns merits one solution over the other. I would opt for the simplest solution - i.e. fixed dose. Simplest solution often means less variation. You may add some considerations about linearity (proportionality).

—
Pass or fail!
ElMaestro

Complete thread:

administered dose for drugs dosed per kg body weight BarbaraM 2014-08-07 14:40
- administered dose for drugs dosed per kg body weightElMaestro 2014-08-07 15:01
- Definition of BE (EMA) Helmut 2014-08-07 15:12
  - Definition of BE (EMA) BarbaraM 2014-08-07 16:31
    - Dosing low or as per 4.2 ElMaestro 2014-08-07 17:42
    - Definition of BE (EMA) Dr_Dan 2014-08-11 00:10
      - Patients or healthy subjects? Helmut 2014-08-11 11:02
- administered dose for drugs dosed per kg body weight luvblooms 2014-08-11 06:56
  - administered dose for drugs dosed per kg body weight Helmut 2014-08-11 11:14
    - administered dose for drugs dosed per kg body weight luvblooms 2014-08-12 06:28
      - Patients or healthy subjects… Helmut 2014-08-12 12:23