Biological method validation(BMV) is a proprietary statistical analysis software for the validation of biological methods and has many advantages. (1) Common performance parameters of bioassay, such as precision value and its upper confidence limit, accuracy value and its corresponding confidence interval and range are provided. (2) Criteria to meet the requirements of the methods, such as total analytical error(TAE), prediction interval and tolerance interval of reportable value, method capability index (MCI) are provided. (3) Some new method application indicators, such as format variability(FV), difference threshold of reportable value, standard deviation of proficiency assessment, and analysis of critical factors of the method are included. (4) It provides applicable model of self-selected biological experiment system, and calculates the sample size required to verify the experiment. The software is easy to use and the output results are accuracy and reliable, which can meet the requirements of the current pharmacopoeia or guidelines of various countries. The development of this software will facilitate drug industry researchers to establish more scientific and reliable biological methods to ensure the quality and safety of drugs.
HAN Lu, SUI Si-lian, TAN De-jiang, DUAN Li, LI Na, DU Ying, SHI Rui-Hong
. Design and function of statistical software for validation of biological methods*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(6)
: 979
-987
.
DOI: 10.16155/j.0254-1793.2022.06.10
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