Fast & fed in one study (alternative) [Design Issues]

posted by jag009  – NJ, 2020-03-04 19:25  – Posting: # 21204
Views: 912

Hi,

» What happens if T is BE to R under fasting and fed but T has much more food effect than R? Will "nice-to-know" become "but-now-I-know-so-you-are-fucked"? What's your experience from regulation perspective?

With FDA → In general they don't care but if they look at your data and see that you borderline past fed (or fast), then they might raise an issue.

J

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