Bioanalytical Community

Recent years, there are more and more cases talking about using cell-based assay for PK analysis. ICH released M10 in November 2022, where it specified biomarkers were not in the scope of the guidance. Biomarker and flow cytometry lives outside the guidance for a while until Jan-2025. FDA just released new biomarker guidance document indicating biomarker measurement should be consistent with the guidance of M10. This replaced 2018 bioanalytical validation guidance biomarker section, where biomarker briefly mentioned. In this release, biomarker assays used in regulatory decision making should be fully validated as described in M10. For other assays not using in decision making, it would be fit-for-purpose, based on sponsor, depending on secondary or exploratory endpoints. Method validation for biomarker assays should address the same questions as drug assay validation. It specifies accuracy, precision, parallelism, specificity, sensitivity, selectivity, range, reproducibility and stability. Some characteristics may not be applicable or achievable for biomarker assay. 

The other guideline is CLS H62, released in 2021 as the first edition. It went to in depth how to perform development and validations within flow cytometry. Both documents, H62 and M10 encourages sponsors to discuss assay plan with FDA review division early in development, to ensure all parameters FDA wants to see are in captured.

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Xiaohui Xu Ph.D.
Director
Daiichi Sankyo
Basking Ridge NJ
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Dear All,

Good evening, and thank you for your contributions. I want to make a request that someone please email me a protocol for PK assay in vitro. My email address is thus? [email protected].

Thank you in anticipation...

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Joshua Nwabuife
Postdoctoral Researcher Fellow
University of the Free State
Bloemfontein
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 04-03-2025 03:03
From: Xiaohui Xu
Subject: AAPS PK Assay Methodology Group January-2025 Meeting minutes_Implementation of Cell-Based PK Assays Using Flow Cytometry

Recent years, there are more and more cases talking about using cell-based assay for PK analysis. ICH released M10 in November 2022, where it specified biomarkers were not in the scope of the guidance. Biomarker and flow cytometry lives outside the guidance for a while until Jan-2025. FDA just released new biomarker guidance document indicating biomarker measurement should be consistent with the guidance of M10. This replaced 2018 bioanalytical validation guidance biomarker section, where biomarker briefly mentioned. In this release, biomarker assays used in regulatory decision making should be fully validated as described in M10. For other assays not using in decision making, it would be fit-for-purpose, based on sponsor, depending on secondary or exploratory endpoints. Method validation for biomarker assays should address the same questions as drug assay validation. It specifies accuracy, precision, parallelism, specificity, sensitivity, selectivity, range, reproducibility and stability. Some characteristics may not be applicable or achievable for biomarker assay. 

The other guideline is CLS H62, released in 2021 as the first edition. It went to in depth how to perform development and validations within flow cytometry. Both documents, H62 and M10 encourages sponsors to discuss assay plan with FDA review division early in development, to ensure all parameters FDA wants to see are in captured.

------------------------------
Xiaohui Xu Ph.D.
Director
Daiichi Sankyo
Basking Ridge NJ
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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