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, 2014-08-12 08:28 (4337 d 20:59 ago) – Posting: # 13364
Views: 9,409

Hi Helmut

❝ I think that EMA’s draft guidance can easily be misinterpreted (see my remarks at the end of this post). Maybe the guidance’s wording is just ambiguous. The 500 mg strength is OK, but should not be interpreted as the suitable dose – which should still be calculated according to the common posology.

Totally agreed to the point raised by you. Also the study has to be done in patients thus using just 500 mg (where as the dose based on BSA lies in 1500-2500 mg) is also not ethically right. We have already asked for clarification on the same from EMEA. Lets see if we can get a reply.

IF the study has to be done on healthy volunteers (after regulatory consultation) using 500 mg should be ok.
Remember Imatinib guidance

—
~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 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 weightluvblooms 2014-08-12 06:28
      - Patients or healthy subjects… Helmut 2014-08-12 12:23