Bioanalytical Methods Validation for Human Studies - Pharmanet

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Draft — Not for Implementation ! A description of the analytical method ! A description of stability studies and supporting data ! A description of experiments conducted to determine accuracy, precision, recovery, specificity, linearity, limit of quantitation, and relevant data obtained from these studies ! Tables of intra- and inter-day precision and accuracy ! Evidence of purity of drug standards, metabolites, and internal standards used in validation experiments ! Deviations from SOP, if any, and justification for deviation Documentation for in-study validation should include: ! Calibration curves used in analyzing samples and intra-day accuracy and precision data ! Information on inter-day values of QC samples and data on inter-day accuracy and precision from calibration curves and QC samples used for accepting the analytical run ! A protocol for reassay of samples that describes the reasons for reassay and acceptance criteria for reassayed samples ! Reasons for missing samples ! Acceptance criteria for reported values when all unknown samples are assayed in duplicate ! Deviations from the protocol or SOP, with reasons and justifications for the deviations Documentation for submission to the Agency should include: ! Pre-study validation data ! Calibration curves, equations, and weighting factors used, if any ! In-study validation data j:\!guidance\2578dft.wpd 12/14/98 11
Draft — Not for Implementation ! Complete serial chromatograms of 20% of subjects, with standards and QC samples ! All SOPs, raw data, calculations of concentration, and reassay sample sets j:\!guidance\2578dft.wpd 12/14/98 12
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