Fast & fed in one study (alternative) [Design Issues]
Hi,
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
❝ 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
- 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