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 BarbaraM – Greece, 2014-08-07 16:40 (4339 d 12:28 ago) – Posting: # 13347
Views: 10,882

Dear Group, I would like to have your views on the below issue. A drug as tablets of 500 mg and 1000 mg is to be dosed in real life by calculating the dose per kg body weight (25 mg/kg).
e.g. a patient of 60 kg will receive a single dose of 1500 mg; that is he will get 1 tab of 1000 mg and 1 tab of 500 mg

a patient of 80 kg will receive a single does of 2000 mg; that is he will get 2 tabs of 1000 mg (or 4 tabs of 500 mg).

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?

Thanking you in advance for your feedback.

Complete thread:

administered dose for drugs dosed per kg body weightBarbaraM 2014-08-07 14:40
- administered dose for drugs dosed per kg body weight ElMaestro 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