Bioequivalence and Bioavailability Forum • Definition of BE (EMA)

Definition of BE (EMA) [Design Issues]

posted by Dr_Dan – Germany, 2014-08-11 02:10 (4336 d 23:25 ago) – Posting: # 13360
Views: 9,452

Dear BarbaraM
First of all one question: Do you need to dose patients? I guess this is the case, right? Bad luck.... You can not mix two strenghts (500 mg and 1000 mg = two formulations) for the assessment of bioequivalence. I would go for a scientific advice proposing the execution of the study with the lower strength.
Kind regards
Dr_Dan

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Kind regards and have a nice day
Dr_Dan

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