Bioequivalence and Bioavailability Forum

Dear Sir/Madam,

Draft Guidance for industry dated September 2013 from FDA on Bioanalytical Method Validation, Section V: Incurred sample reanalysis, line no. 757 & 758, it was mentioned as “ISR samples should be compared to freshly prepared calibrators”.

Workshop Report: Crystal City V White Paper dated 31 December 2014, under consensus topic, Incurred sample reanalysis it is mentioned as “If a bulk frozen calibration curve was used for the original analysis, then it is acceptable to use a frozen curve for the ISR evaluation”.

Should we use bulk frozen calibration curve for ISR sample analysis or freshly prepared calibrators?

Thanks & regards,
Avinash Jain

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Edit: Category changed and documents linked. [Helmut]