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

posted by Shuanghe  – Spain, 2020-03-04 16:13 (205 d 02:34 ago) – Posting: # 21203
Views: 1,783

Dear Helmut

» If T shows a substantially lower food effect than R that’s good for the patients. However, if you want to state that in the label/SmPC (“can be taken with or without food”) you have to switch from a generic to a hybrid application. The EMA welcomes that. Whether the additional clinical studies are worth the efforts is another story.

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?

All the best,

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