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

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

posted by jag009 – NJ, 2020-03-04 19:25 (365 d 03:36 ago) – Posting: # 21204
Views: 2,005

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

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