生物类似药的稳定性研究设计与分析

生物制品对光线和温度等环境因素高度敏感,这些因素可能影响药物的质量和有效性。由于制造过程的各种差异,生物类似药只能与参比制品相类似。因此,为了确保生物类似药的活性在有效期内符合批准的标准规定,对其进行严格的稳定性测试至关重要。本文介绍使用阵列式设计(matrix designs)与统计分析研究生物制品的长期稳定性特征。研究基于1/3和2/3的按时设计构建了阵列式设计,考察了强度、批次和包装等多种因素。阵列数据既可经检验进行合并性(poolability)分析,也可不经检验直接进行合并性分析。这些方法将有助于降低生物制品开发注册过程中稳定性和保质期研究的成本。

Biological drug products are highly sensitive to environmental factors such as light and temperature which may impact the quality and effectiveness of the drug.Biosimilars can only be similar to the reference product due to variations within the manufacturing process.Because of this, rigorous stability testing is crucial to assure that the potency of a biosimilar product is within approved specification prior to its expiration date.This paper presents matrix study designs and statistical analyses for the establishment of stability profiles of biological products in long term studies.It considers matrix designs based on 1/3 and 2/3 on-time designs with multiple factors such as strength, batch, and package.Statistical analyses of the matrix data may be performed as one analysis either with or without testing for poolability.Such methods will help reduce costs for developers of biological drug products in establishing the stability and shelf life of a drug for regulatory approval.