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Registerextended release [Design Issues]
Dear Sir, I read a protocol for a Be study for an extended - release formulation.
It was a single dose study(only in fasted conditions) and multi- dose study. In this study, the first period of the single dose study was followed by the first period of the steady – state study. The wash out period began after the last dose administered in the steady - state study. The second period was identical with the first one. Is correct this design for the study?
I know that for extended - release formulations must be performed totally different studies (single dose and multi - dose studies) in different periods. Is this correct?
Thank you.
It was a single dose study(only in fasted conditions) and multi- dose study. In this study, the first period of the single dose study was followed by the first period of the steady – state study. The wash out period began after the last dose administered in the steady - state study. The second period was identical with the first one. Is correct this design for the study?
I know that for extended - release formulations must be performed totally different studies (single dose and multi - dose studies) in different periods. Is this correct?
Thank you.
Complete thread:
- extended releaseioanam 2007-01-22 11:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- extended release (SD+MD) Helmut 2007-01-22 18:32
- extended release (SD+MD) shabana 2007-01-31 05:16
- switch-over design Helmut 2007-01-31 13:49
- switch-over design shabana 2007-02-12 10:38
- switch-over design Helmut 2007-02-12 15:09
- switch-over design shabana 2007-02-13 05:33
- switch-over design Helmut 2007-02-13 11:34
- switch-over design shabana 2007-02-13 05:33
- switch-over design Helmut 2007-02-12 15:09
- switch-over design shabana 2007-02-12 10:38
- switch-over design Helmut 2007-08-23 21:10
- switch-over design Helmut 2007-01-31 13:49
- extended release (SD+MD) shabana 2007-01-31 05:16
- extended release (SD+MD) Helmut 2007-01-22 18:32
Ing. Helmut Schütz