Objective: To elaborate systematically the evaluation indexes and acceptance criteria of method capabilitys and provide a reference for scientific and multi-perspective assessments of method capability. Methods: The capability assessment indexes and their acceptance criteria were discussed for satisfying its intended use by starting with the definition, calculation formula, use and meaning of each index, combined with the validation characteristics of bioassay. Results: The new developed method capability assessment indexes for judging whether the method meets the intended use included(1) total analytical error of analytical procedure (TAE); (2) Prediction interval (RVPI) and tolerance interval (RVTI) of reportable values; (3) Method capability index (MCI) and misjudgment probability of method (MMJP). The five indexes were provided for evaluating capability assessment of method quantitatively from different perspectives and could be more intuitive, for drug developers and regulators to evaluate the method capability. Conclusion: More directly related and easy-to-understand indexes for method capability assessment could be obtained by usin g precise validation dataset of method and statistical techniques, and the capability assessment indexes of the new methods could enrich the attribute set of the method, and also help us to have a more in-depth understan ding of it.
DUAN Li, HAN Lu, DU Ying, LI Na, XU Hui, TAN De-jiang
. Discussion on the evaluation indexes and criteria of assay for satisfying its intended use*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(6)
: 966
-971
.
DOI: 10.16155/j.0254-1793.2022.06.08
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