Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report

Abstract

This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held prior to the American Association of Pharmaceutical Scientists (AAPS) PharmSci360 Congress, San Antonio, TX, November 2019. The purpose of the workshop was to bring together thought leaders in biomarker assay development in order to identify which assay parameters and key statistical measures need to be considered when developing a biomarker assay. A diverse group of more than 40 scientists participated in the workshop. The workshop and subsequent working dinner stimulated robust discussion. While a consensus on best practices was not achieved, some common themes and major points to consider for biomarker assay development have been identified and agreed on. The focus of this conference report is to summarize the presentations and discussions which occurred at the workshop. Biomarker assay validation is a complex and an evolving area with discussions ongoing.

Bioanalysis of Stress Biomarkers through Sensitive HILIC-MS/MS Method: A Stride toward Accurate Quantification of MDA, ACR, and CTA

“…l -Glutamine- 13 C 5 , 15 N 2 was used as an internal standard (ISTD) for the bioanalytical method based on its structural similarity to the analytes. Fit-for-purpose method validation has been performed for the developed method according to the guidelines. , The bioanalytical method was validated for its accuracy, precision, and linearity over the operating range. The linearity range for MDA was selected based on its reported levels in humans .…”

“…Fit-for-purpose method validation has been performed for the developed method according to the guidelines. 40,41 The bioanalytical method was validated for its accuracy, precision, and linearity over the operating range. The linearity range for MDA was selected based on its reported levels in humans.…”

How to Accelerate Early Stage of Malaria Vaccine Development by Optimizing Functional Assays

“…On the other hand, there is no commonly accepted definition for “standardization”, “optimization”, “qualification”, or “pre-validation”. Not only is there confusion in the terminology, but there could also be different processes of “validation” for different assays, as each assay needs to be validated by “fit-for-purpose” [ 40 ]. In other words, depending on the characteristics and/or usage of the assay, different assays could be validated differently.…”