Fast & fed studies [Design Issues]

posted by alghazam – Jordan, 2020-03-03 10:24 (938 d 12:20 ago) – Posting: # 21193
Views: 2,780

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

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