Biomarker Assay Validation by Mass Spectrometry - The AAPS Journal
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| Biomarker Assay Validation by Mass Spectrometry - The AAPS Journal |
| Decades of discussion and publication have gone into the guidance from the scientific community and the regulatory agencies on the use and validation of pharmacokinetic and toxicokinetic assays by chromatographic and ligand binding assays for the measurement of drugs and metabolites. These assay validations are well described in the FDA Guidance on Bioanalytical Methods Validation (BMV, 2018). |
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Ho-Leung Fung Ph.D., FAAPS
Editor-in-Chief
University at Buffalo
Buffalo NY
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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