Bioequivalence and Bioavailability Forum

Loky do
★

Egypt,
2022-03-16 10:10
(1150 d 20:55 ago)

Posting: # 22838
Views: 2,975

Reanalysis of volunteers [Study Assessment]

Dears

After bioanalysis of 30% of volunteers in a bioequivalence study, the terminal phase samples of those volunteers were not adequately detected, a partial validation will be performed to lower the LLOQ to be able to detect those samples, is it accepted to reanalyze those volunteers? could it raise questions by authorities? as it may bias the outcome of the study, or just to analyze the rest of volunteers after lowering the LLOQ and use their data along with the 30% volunteers in calculations?

Thanks in advance

dshah ★★ India, 2022-03-16 17:37 (1150 d 13:29 ago) @ Loky do Posting: # 22840 Views: 2,323	Reanalysis of volunteers Post reply
	Dear Loky Do! You can do partial validation and then improve analysis for the rest of 70%, but I believe reanalysis for PK consideration would cause bias and thus raise questions by authorities. regards, Dshah

Reanalysis of volunteers [Study As­sess­ment]

Reanalysis of volunteers

Reanalysis of volunteers [Study Assessment]