PDF(Pubmed)
Abstract：
Background: Measuring pharmacodynamic biomarkers near the therapeutic site of action presents considerable challenges for sites with limited matrix volume or difficult access. Bioanalytical method qualification requires the use of numerous matrix samples, which is problematic for rare matrices. The aim of this study was to design and implement a streamlined, fit-for-purpose strategy for qualification of biomarker assays in rare matrices. Materials & methods: A multiplexed biomarker immunoassay was developed in human aqueous humor. Results: Our strategy was successfully implemented, providing characterization of assay performance while reducing number of samples in assay qualification. Our assay was used in clinical trial support for an ophthalmic drug candidate. Conclusion: Our results indicate this approach can be applied to other early stage drug development programs facing similar challenges.
Bioanalytical assay development and qualification requires the use of numerous matrix samples, which is problematic for rare matrices. We designed and successfully implemented a streamlined strategy for qualification of biomarker assays in rare matrices.
Bioanalytical assay development and qualification requires the use of numerous matrix samples, which is problematic for rare matrices. We designed and successfully implemented a streamlined strategy for qualification of biomarker assays in rare matrices.
摘要：
背景：测量治疗作用部位附近的药效学生物标志物对于基质体积有限或难以接近的部位提出了相当大的挑战。生物分析方法鉴定需要使用大量的基质样品，这对稀有矩阵是有问题的。这项研究的目的是设计和实施一个精简的，稀有基质中生物标志物检测资格的适合目的策略。材料和方法:在人房水中开发了多重生物标志物免疫测定。结果:我们的战略成功实施,提供测定性能的表征，同时减少测定资格中的样品数量。我们的测定用于眼科候选药物的临床试验支持。结论：我们的结果表明这种方法可以应用于其他面临类似挑战的早期药物开发计划。
生物分析测定的开发和鉴定需要使用大量的基质样品，这对稀有矩阵是有问题的。我们设计并成功实施了一种简化的策略，用于在稀有基质中对生物标志物进行鉴定。
生物分析测定的开发和鉴定需要使用大量的基质样品，这对稀有矩阵是有问题的。我们设计并成功实施了一种简化的策略，用于在稀有基质中对生物标志物进行鉴定。
