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Registerstudy sample analysis [Bioanalytics]
hi,
i would like to seek some advice regarding the analysis of study sample from regulatory point of view.
scientifically, would it be acceptable to not analyze all study samples from a in a single run (i.e multiple runs) as long as the bioanalytical method has completely been validated and documented acceptable inter-assay variability?.
is there any justification behind the acceptance of single / multiple run(s) analysis results?
is there any references/guidelines that i can refer to regarding this matter?
thanx!
i would like to seek some advice regarding the analysis of study sample from regulatory point of view.
scientifically, would it be acceptable to not analyze all study samples from a in a single run (i.e multiple runs) as long as the bioanalytical method has completely been validated and documented acceptable inter-assay variability?.
is there any justification behind the acceptance of single / multiple run(s) analysis results?
is there any references/guidelines that i can refer to regarding this matter?
thanx!
Complete thread:
- study sample analysisFalisa_Mustafa 2012-01-20 04:06
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- study sample analysis Helmut 2012-01-20 13:22
Ing. Helmut Schütz