Bioequivalence and Bioavailability Forum

Patients or healthy subjects… [Design Issues]

posted by Helmut  – Vienna, Austria, 2014-08-12 14:23 (4339 d 10:39 ago) – Posting: # 13369
Views: 9,435

Hi Luv,

❝ […] 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.

Did you also send a comment on the draft guidance to the EMA (as I did)?

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

Yes.

❝ Remember Imatinib guidance

I do.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Science Quotes

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 weight luvblooms 2014-08-12 06:28
        • Patients or healthy subjects…Helmut 2014-08-12 12:23