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RegisterDefinition of BE (EMA) [Design Issues]
Hi! thank you both for the quick feedback and the Greek salut 
.
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.
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?
.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.
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?
Complete thread:
- administered dose for drugs dosed per kg body weight BarbaraM 2014-08-07 14:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- Definition of BE (EMA)BarbaraM 2014-08-07 16:31
- 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
- administered dose for drugs dosed per kg body weight luvblooms 2014-08-12 06:28
- administered dose for drugs dosed per kg body weight Helmut 2014-08-11 11:14
Ing. Helmut Schütz