Pfizer Worldwide Research and Development, Analytical Research and Development, 558 Eastern Point Road, Groton, CT 06340, United States.
Pfizer Worldwide Research and Development, Statistics, 558 Eastern Point Road, Groton, CT 06340, United States.
J Pharm Biomed Anal. 2017 Nov 30;146:59-67. doi: 10.1016/j.jpba.2017.08.010. Epub 2017 Aug 16.
Drug product assay is one of several tests required for new drug products to ensure the quality of the product at release and throughout the life cycle of the product. Drug product assay testing is typically performed by preparing a composite sample of multiple dosage units to obtain an assay value representative of the batch. In some cases replicate composite samples may be prepared and the reportable assay value is the average value of all the replicates. In previously published work by Harrington et al. (2014) [5], a sample preparation composite and replicate strategy for assay was developed to provide a systematic approach which accounts for variability due to the analytical method and dosage form with a standard error of the potency assay criteria based on compendia and regulatory requirements. In this work, this sample preparation composite and replicate strategy for assay is applied to several case studies to demonstrate the utility of this approach and its application at various stages of pharmaceutical drug product development.
药品含量测定是新药产品的几项测试之一，以确保产品放行时和整个产品生命周期内的产品质量。药品含量测定测试通常通过制备多个剂量单位的复合样品来获得代表批次的含量测定值。在某些情况下，可能会制备重复的复合样品，报告的含量测定值是所有重复的平均值。在 Harrington 等人之前发表的工作中。(2014 年)[5]，开发了一种用于含量测定的样品制备复合和重复策略，提供了一种系统的方法，该方法考虑了由于分析方法和剂型引起的变异性，并基于药典和监管要求，以效力测定标准的标准误差为基础。在这项工作中，将这种用于含量测定的样品制备复合和重复策略应用于几个案例研究，以证明这种方法的实用性及其在药物产品开发的各个阶段的应用。
