Incurred sample reanalysis [Bioanalytics]

posted by han16 – 2009-02-17 12:40 (6337 d 14:39 ago) – Posting: # 3256
Views: 4,590

Dear Ohlbe,

I have a question, that is now a days everyone is opting for incurred samples reanalysis (ISR), and preparing their own in house Standard Operating Procedures for the same, everything looks good if the results obtained after incurred samples reanalysis are within the limits but in case if the results of the samples deviate from the acceptance criteria, for example the whole batch got failed, then you may say anyway ISR is selected from the duplicate samples thus sample volume is available,in a case where no sample volume available for example pre-clinical PK samples then how are we going to address the issue.

Please guide. :-)

Thanking you in advance

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