Bioequivalence and Bioavailability Forum • Pre-dose concentration found higher than preceding sample

Mitesh Panchal
☆

India,
2015-08-30 06:54
(3154 d 17:32 ago)

Posting: # 15363
Views: 5,517

Pre-dose concentration found higher than preceding sample [Bioanalytics]

Hello Everyone,

I have faced following issue,

I have found concentration in pre-dose sample and that concentration is higher than last sample / time point of Period 01 (i.e. P02, pre-dose concentration is higher than its preceding sample).

In such case we need to repeat the sample (i have repeated sample).

My doubt is,

If i found repeated value different from initial value then what to do? we need to accept which value??? (Initial / Repeated / we need to reported as NR)

eg.

Initial Value - 251 ng / mL
Repeated Value - 0.oo ng / mL (totally different value)

Please give me your suggestions.

Regards,
Mitesh Panchal

mittyri
★★

Russia,
2015-08-30 21:24
(3154 d 03:02 ago)

@ Mitesh Panchal
Posting: # 15364
Views: 4,557

pre-dose concentrations above LLOQ: useful topics

Post reply

Dear Mitesh,

I think you can find the answer in the following topics: here, here or here

In a nutshell:
EMA BE GL states:
Reanalysis of study samples should be predefined in the study protocol (and/or SOP) before the actual start of the analysis of the samples.

EMA bioanalytical method validation GL states that:
In case of reanalysis because of positive pre-dose samples or because of a pharmacokinetic reason, the reanalysed samples should be identified and the initial value, the reason for reanalysis, the values obtained in the reanalyses, the finally accepted value and a justification for the acceptance should be provided

Hope it helps

—
Kind regards,
Mittyri

Mitesh Panchal ☆ India, 2015-08-30 22:14 (3154 d 02:12 ago) (edited by Ohlbe on 2015-08-30 22:30) @ mittyri Posting: # 15365 Views: 4,581	pre-dose concentrations above LLOQ: useful topics Post reply
	Thank you mittyri Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]