Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples.
Characterization of the stability of analytes in biological samples collected during clinical studies together with that of critical assay reagents, including analyte stock solutions, is recognized as an important component of bioanalytical assay validation. Deficiencies in these areas often come to light during regulatory inspections. Best practices, based on current regulatory guidance, for the assessment of these issues as they pertain to ligand binding and chromatographic assays are covered in this review. Additionally, consensus recommendations reached during the recent AAPS/FDA Workshop on bioanalytical assay validation are highlighted.
Nowatzke
William
W
Amgen, Inc, Department of Pharmacokinetics and Drug Metabolism, Thousand Oaks, CA 91320, USA. nowatzke@amgen.com
Woolf
Eric
E
D000818:Animals; D001702:Biopharmaceutics / Q000379:methods / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards; D004355:Drug Stability; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results
D004364:Pharmaceutical Preparations