Bioequivalence and Bioavailability Forum • Dosing low or as per 4.2

Dosing low or as per 4.2 [Design Issues]

posted by ElMaestro – Denmark, 2014-08-07 19:42 (4340 d 18:48 ago) – Posting: # 13351
Views: 9,549

Hi BarbaraM,

❝ Indeed I'm referring to a standard 2-way cross over BE. My concern rises from the fact that if we dose 1 tab of 1000 mg (highest strength) then depending on the subject's body weight this will result in doses much less than the 25 mg/kg that is specified in the SmPC (e.g. for the 60 kg subject would result in ~17 mg/kg) and I assume that this will result in a Cmax and AUC less than the SmPC proposes.

Note that dosing per SPC is not a goal in itself (at least not for EU submissions).

❝ It would be as if we had 2 strength of a product and we were to dose the smallest strength, instead of the highest as the EMA guideline proposes to be the most discriminatory case.

❝ What do you think? Does this make any sense?

Could be succesful. At least the low strenght will be approvable if the study turns out equivalent. If you can argue less-than-proportional kinetics or a safety concern then you may have an additional good argument.

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Pass or fail!
ElMaestro

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 4.2ElMaestro 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