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RegisterFast & fed in one study (alternative) [Design Issues]
posted by Helmut 
– Vienna, Austria, 2020-03-05 12:50 (1680 d 07:50 ago) – Posting: # 21206
Views: 3,641
Hi Shuanghe,
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.
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?
❝ 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?
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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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 studies alghazam 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