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RegisterFast & fed studies [Design Issues]
Dear Amira,
It is clearly stated in EMA guidance of 2010 on page 10/27 (lines 6-7) that "In cases where information is required in both the fed and fasted states, it is acceptable to conduct either two separate two-way cross-over studies or a four-way cross-over study."
hope this helps.
Mutasim
It is clearly stated in EMA guidance of 2010 on page 10/27 (lines 6-7) that "In cases where information is required in both the fed and fasted states, it is acceptable to conduct either two separate two-way cross-over studies or a four-way cross-over study."
hope this helps.
Mutasim
Complete thread:
- Fast & fed studies Amira Gouda 2020-03-01 20:28 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fast & fed studiesalghazam 2020-03-03 10:24
- Fast & fed studies Ohlbe 2020-03-03 11:58
- Fast & fed in one study (alternative) Helmut 2020-03-04 14:15
- Fast & fed in one study (alternative) Shuanghe 2020-03-04 16:13
- Fast & fed in one study (alternative) jag009 2020-03-04 19:25
- Fast & fed in one study (alternative) Helmut 2020-03-05 11:50
- Fast & fed in one study (alternative) Shuanghe 2020-03-05 16:02
- Fast & fed in one study (alternative) Marcelo Davanco 2020-03-06 13:35
- Fast & fed in one study (alternative) Shuanghe 2020-03-05 16:02
- Fast & fed in one study (alternative) Shuanghe 2020-03-04 16:13
- Fast & fed in one study (alternative) Helmut 2020-03-04 14:15
Ing. Helmut Schütz