Bioequivalence and Bioavailability Forum • Rechallenge (or re-dosing) study

Rechallenge (or re-dosing) study [Regulatives / Guidelines]

posted by jag009 – NJ, 2014-10-01 22:53 (4287 d 05:06 ago) – Posting: # 13638
Views: 4,143

Hi all,

Hmmm. I posted this message in the morning (and clicked submit) but the message wasn't posted... Anyhow...

What roles do the control subjects play in a re-challenge study for BE? Lets say if the controls respond differently then what happens? Does that invalidate the re-challenge? Response differently meaning they were BE (with 80-125% ratio) but fail miserably in the re-challenge.
Does the re-challenge study have to follow the exact same design as the original study? If the original study is a 3x3x6 study with 2 formulas and the outlier is detected for 1 of the 2 formulas, do the re-challenge study have to follow the same design 3x3x6? I said yes but there are others who said no.
What qualifies for re-challenge? Does the outlier have to show abnormal values for both Cmax and AUCs parameters or you can re-challenge if he/she shows only abnormal value for 1 parameter? I don't agree to the latter but I have seen re-challenge studies done in the past due to 1 parameter and this bugs me.

Thanks
John

Rechallenge (or re-dosing) studyjag009 2014-10-01 20:53
- Rechallenge (or re-dosing) study luvblooms 2014-10-07 07:51
  - Rechallenge (or re-dosing) study jag009 2014-10-08 15:51
    - Rechallenge (or re-dosing) study luvblooms 2014-10-09 06:10