本文以效价限度标准制定为例,阐述了在产品质量标准中主成分限度标准的科学制定应考虑的基本因素及制定原理,包括(1)依据产品的安全性、有效性、工艺波动和稳定性波动范围等综合确定生物效价标示值的正常波动范围。(2)依据检测方法的检测能力(方法变异大小)确定效价标示值的相对置信范围。(3)给出以标示值精密度为依据确定的效价标示值有效数字位数。
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.
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