Analytical Method Validation Data For Submission To

Information that should be submitted in an NDA or an ANDA for the analytical method validation should include the following:

• Summaries: A summary table that lists the validation studies by title and number, and a table of the assay methods used in the study (s).

• Method Establishment information: This should include a description of the analytical method(s), evidence of analyte purity, description of stability studies, description and tabulation of accuracy and precision determinations, cross-validation studies if necessary, legible chromatograms, or mass spectrograms including blanks (up to 20% of chromatograms from three serial patients for pivotal bioequivalence studies), and a list of deviations from protocols and explanations for these deviations.

• Application of the validated method: Summary table of sample handling, summary table of clinical or preclinical samples, equations used, table of calibration curve data, summary tables of intra and inter assay accuracy and precision, and of QC samples, reasons for missing samples, reanalyzed samples, and reintegrated samples.

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