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 luvblooms – India, 2014-08-11 08:56 (4336 d 00:32 ago) – Posting: # 13361
Views: 9,414

Dear Barbara

❝ 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?

You can Check the EMA BE requirment for Capecitabine.

For Capectiabine Standard and reduced dose calculations according to body surface area for starting doses of capecitabine of 1250mg/m2 and 1000mg/m2, respectively but for BE study Strength to be used is 500 mg because it is the highest strength.

Hope this will help.

—
~A happy Soul~

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 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 weightluvblooms 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