Taking the setting up acceptance criteria of biological potency as an example, the basic elements and principles that should be confided in setting up the acceptance criteria of principal component were expounded, including (1)comprehensively determining the normal fluctuation range of the stated relative potency according to the safety, effectiveness, process fluctuation and stability range of the biologics; (2)determining the relative confidence range of the stated relative potency according to the capability of the bioassay (variability of the method); (3)giving the number of significant figures of the stated relative potency determined according to the precision of the stated relative potency.
TAN De-jiang, HAN Lu, DUAN Li, LI Na, DU Ying, LIANG Zheng-lun
. Discussion on key points for setting up the acceptance criteria of biological potency*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(6)
: 956
-961
.
DOI: 10.16155/j.0254-1793.2022.06.06
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