Refuse-to-Receive Standards [Design Issues]
Hi David,
A replicate design is advantageous if aiming at reference-scaling. However, the FDA is special. If RSABE is not stated in the respective product-specific guidance1 (as an alternative to ABE) I would not risk it2 without controlled correspondence first – otherwise one may fall into this trap.
Indeed.
❝ […] would it be acceptable to use different designs for each study? Even when the variability in the fed study was preivously found to be higher in pilot studies, for example?
A replicate design is advantageous if aiming at reference-scaling. However, the FDA is special. If RSABE is not stated in the respective product-specific guidance1 (as an alternative to ABE) I would not risk it2 without controlled correspondence first – otherwise one may fall into this trap.
❝ […] from my experience fed studies generally have higher variability than fast studies even when no food effect is expected.
Indeed.
- Most in draft state and published before April 2010 (when RSABE was for the first time mentioned by the FDA).
Omeprazole, Pantoprazole: No. Lansoprazole: Yes (only fasting).
- Of course, in statistical terms any replicate design – even if aimed only at ABE – is better than a simple crossover.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Fed VS Fast state in BE studies M.tareq 2017-02-26 09:34 [Design Issues]
- Fed VS Fast state in BE studies Dr_Dan 2017-02-27 11:01
- PPIs sometimes highly variable even in fasted state Helmut 2017-02-27 11:32
- PPIs sometimes highly variable even in fasted state DavidManteigas 2017-02-27 16:08
- Refuse-to-Receive StandardsHelmut 2017-02-27 16:25
- Refuse-to-Receive Standards M.tareq 2017-03-17 13:11
- Refuse-to-Receive Standards nobody 2017-03-17 16:27
- Refuse-to-Receive StandardsHelmut 2017-02-27 16:25
- PPIs sometimes highly variable even in fasted state DavidManteigas 2017-02-27 16:08
- PPIs sometimes highly variable even in fasted state Helmut 2017-02-27 11:32
- Fed VS Fast state in BE studies Dr_Dan 2017-02-27 11:01