Bioequivalence and Bioavailability Forum • Fast & fed in one study (alternative)

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?

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All the best,
Shuanghe

Complete thread:

Fast & fed studies Amira Gouda 2020-03-01 20:28 [Design Issues]
- 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