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

posted by Helmut Homepage – Vienna, Austria, 2020-03-05 10:50 2a02:8388:6bc2:ce80:856f:1d4e:74d9:7171 – Posting: # 21206
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Hi Shuanghe,

» 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"?

By “much more” you mean that the 90% CI is entirely outside the 80-125% limits, right? This means only that you have to forget the idea of a hybrid application.
Everything else (CI overlapping the limits) is indecisive and would not worry me. Even if you are completely outside (T demonstrated a larger food effect than R) – since both fasting and fed passed BE – stay with the generic pathway and you should be fine.

» What's your experience from regulation perspective?

Nil – also for the “nice” case. Though the EMA stated in various conferences to welcome such a hybrid application, I haven’t seen one so far. Any experience from the members?

Cheers,
Helmut Schütz
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