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RegisterFutile… [RSABE / ABEL]
posted by Helmut 
– Vienna, Austria, 2014-11-20 15:39 (3827 d 23:41 ago) – Posting: # 13894
Views: 9,047
Hi Khaoula,
according to both FDA’s and EMA’s requirements you have to perform studies both in fasting and fed state. With a PE of 117.7% for Cmax and significant differences of all PK metrics IMHO any further studies with this formulation are futile.
according to both FDA’s and EMA’s requirements you have to perform studies both in fasting and fed state. With a PE of 117.7% for Cmax and significant differences of all PK metrics IMHO any further studies with this formulation are futile.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
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Complete thread:
- pilot replicate design khaoula 2014-11-19 12:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- pilot replicate design ElMaestro 2014-11-19 12:38
- pilot replicate design khaoula 2014-11-19 14:11
- N=24?? ElMaestro 2014-11-19 14:29
- pilot replicate design Helmut 2014-11-19 15:18
- pilot replicate design khaoula 2014-11-19 15:57
- Futile…Helmut 2014-11-20 14:39
- new information khaoula 2014-11-21 12:19
- kinetica khaoula 2014-11-22 10:38
- kinetica Helmut 2014-11-22 12:43
- Futile…Helmut 2014-11-20 14:39
- pilot replicate design khaoula 2014-11-19 15:57
- pilot replicate design khaoula 2014-11-19 14:11
- pilot replicate design ElMaestro 2014-11-19 12:38
Ing. Helmut Schütz