Bioequivalence and Bioavailability Forum • incurred sample analysis

krishnamurthy ca
☆

2008-02-25 06:55
(6697 d 02:39 ago)

Posting: # 1628
Views: 4,371

incurred sample analysis [Bioanalytics]

Dear Members
with regard to above subject, i have the following queries:

1. What types of studies? Can we do this excercise using pilot studies / failed studies and hence, skip performing for submission studies. (ensuring molecule and all other aspects of method remain the same). We understand that these studies also become auditable, however, this will help us save precious samples collected for submission studies.

2. When to do?
We can plan this in the protocol itself and state that the samples will be selected randomly after analysis is completed. this is because we know exactly the concentrations of each subject time point wise and hence, its easy for us to get a good spread across the calibration range, across subjects. OR
should we perform before know the actual concentrations? (in this case, we may or may not get a spread across analytical range)

thanks in advance
Krishna

Ohlbe
★★★

France,
2008-02-25 20:25
(6696 d 13:10 ago)

@ krishnamurthy ca
Posting: # 1632
Views: 3,460

incurred sample analysis

Post reply

Dear Krishna,

AAPS organised a 2-day workshop on incurred sample reanalysis a few weeks ago, I don't know yet what was the outcome of the meeting. But you can already get some answers from the 2006 Crystal City white paper.

❝ 1. What types of studies? Can we do this excercise using pilot

❝ studies / failed studies

I would say yes, as long as these samples are representative of the samples in your next studies (approximately the same dose and hence same range of concentrations, same matrix, same anticoagulant, same species in the case of pre-clinical studies, same population in the case of patients, same concomittant medications if any).

❝ ... we know exactly the concentrations of each subject time point wise

❝ ...(in this case,we may or may not get a spread across analytical range)

The idea is not only to have low and high concentrations of your analyte, but also high and low concentrations of its metabolites, if any. You should then use samples from various sampling times, in order to cover both aspects. But this has probably been discussed in the recent Crystal City meeting. If somebody here gets some feedback, it would be of interest for everybody.

Regards
Ohlbe