Yang Harry, Kim Hyun Jun, Zhang Lanju, Strouse Robert J, Schenerman Mark, Jiang Xu-Rong
MedImmune, LLC, Gaithersburg, MD.
PDA J Pharm Sci Technol. 2012 May-Jun;66(3):262-9. doi: 10.5731/pdajpst.2012.00867.
Parallelism is a prerequisite for the determination of relative potency in bioactivity assays. It involves the testing of similarity between a pair of dose-response curves of reference standard and test sample. The evaluation of parallelism is a requirement listed by both the United States Pharmacopeia (USP) and European Pharmacopeia (EP). The revised USP Chapters 〈1032〉 and 〈1034〉 suggest testing parallelism using an equivalence method. However, implementation of this method can be challenging for laboratories that lack experience in statistical analysis and software development. In this paper we present a customized assay analysis template that is developed based on a fully good manufacturing practice (GMP)-compliant software package. The template allows for automation of the USP-recommended equivalence parallelism testing method for 4PLmodel in bioassays. It makes the implementation of the USP guidance both practical and feasible. Use of the analysis template is illustrated through a practical example.
Parallelism is a prerequisite for the determination of relative potency in bioactivity assays. It involves the testing of similarity between a pair of dose-response curves of reference standard and test sample. The evaluation of parallelism is a requirement listed by both the United States Pharmacopeia (USP) and European Pharmacopeia (EP). The revised USP Chapters 〈1032〉 and 〈1034〉 suggest testing parallelism using an equivalence method. However, implementation of this method can be challenging for laboratories that lack experience in statistical analysis and software development. In this paper we present a customized assay analysis template that is developed based on a fully good manufacturing practice (GMP)-compliant software package. The template allows for automation of the USP-recommended equivalence parallelism testing method for 4-parameter logistic model in bioassays. It makes the implementation of the USP guidance both practical and feasible. Use of the analysis template is illustrated through a practical example.
平行性是生物活性测定中确定相对效价的前提条件。它涉及对参考标准品和测试样品的一对剂量反应曲线之间的相似性进行检测。平行性评估是美国药典（USP）和欧洲药典（EP）列出的一项要求。修订后的USP第〈1032〉章和〈1034〉章建议使用等效性方法检测平行性。然而，对于缺乏统计分析和软件开发经验的实验室来说，实施该方法可能具有挑战性。在本文中，我们展示了一个基于完全符合良好生产规范（GMP）的软件包开发的定制化测定分析模板。该模板可实现USP推荐的生物测定中四参数逻辑模型等效性平行性检测方法的自动化。它使USP指南的实施既切实可行。通过一个实际例子说明了分析模板的使用。
平行性是生物活性测定中确定相对效价的前提条件。它涉及对参考标准品和测试样品的一对剂量反应曲线之间的相似性进行检测。平行性评估是美国药典（USP）和欧洲药典（EP）列出的一项要求。修订后的USP第〈1032〉章和〈1034〉章建议使用等效性方法检测平行性。然而，对于缺乏统计分析和软件开发经验的实验室来说，实施该方法可能具有挑战性。在本文中，我们展示了一个基于完全符合良好生产规范（GMP）的软件包开发的定制化测定分析模板。该模板可实现USP推荐的生物测定中四参数逻辑模型等效性平行性检测方法的自动化。它使USP指南的实施既切实可行。通过一个实际例子说明了分析模板的使用。
