Bioequivalence and Bioavailability Forum • What to do with Whole period (Test or reference) is zero

Mohamed Yehia
★

Egypt,
2017-12-13 17:37
(2318 d 09:38 ago)

Posting: # 18062
Views: 3,109

What to do with Whole period (Test or reference) is zero [Regulatives / Guidelines]

Hi All,

I want to know if there is any guidelines that talked about what to do if whole one period concentrations (Test or Reference) was zero.

I know statistically that in such case, the whole period or subject is deleted. But I am looking for a reference or guidelines for that.

I know that there is a guidelines talking about the reference and also the test in very low conc. However, my case is that the test is Zero not very low conc.

Thanks.

DavidManteigas
★

Portugal,
2017-12-13 17:51
(2318 d 09:24 ago)

@ Mohamed Yehia
Posting: # 18063
Views: 2,590

What to do with Whole period (Test or reference) is zero

Post reply

Hi Mohamed,

Tricky question. The concentrations are not 0, they are just under the LLOQ, so you may impute the values as missing, 0 or 1/2 of the LLOQ. Therefore, depending on the method, you would be able to use the subject in the statistical analysis at least for Cmax and AUC0-t. But I think it's a bit odd. Would be very glad to know what the experts of the forum think about this subject. I imagine that such an occurrence might be very rare and should be further explored with the clinical team (for instance, have the subject really taken the pills?). If I was responsible for reviewing the dossier for this study, I would surely recommend an inspection :-D

Regards,
David

mittyri ★★ Russia, 2017-12-16 23:44 (2315 d 03:32 ago) @ Mohamed Yehia Posting: # 18066 Views: 2,338	What to do with Whole period (Test or reference) is zero Post reply
	Dear Mohamed, I think this thread could be useful for you — Kind regards, Mittyri