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Does anyone know of current guidelines regarding incurred sample reanalysis with acceptance criteria and dealing with haemolysed samples?
Division of Clinical Pharmacology
University of Cape Town
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There are no real guidelines as of this note. There are numerous suggestions.
1) Develop an SOP describing when you are going to do the assay. Most recommendation are to run the re-analysis as early as possible. (The way most people describe it stability should not be a component but I so not understand why it isn't). 2) Be sure to focus on samples near the Cmax and near the LLOQ.
3) Use samples from different patients - do not re-analyze the PK profile from one or two patients ( the only real impact a great variance would have would be on the pharmacokinetic data why you would avoid this assessment escapes me).
4) Use your QC sample criteria (%CV) or some variation of %Bias using the initial measure as the reference (nominal?). Use 20 to 30% for the acceptance for individuals and an overall requirement that 67 to 80% of the samples re-analysed must meet the requirement.
5) Summarize the data both in the sample analysis report and in an amendment to the validation report.
You can also do a search using ISR or incurred sample re-analysis to pick up the position/ white papers.
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