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Regulatory and scientific considerations in PK and biomarker assay validation: lessons from bioanalytical practice

Ruwini D Rajapaksha1, John T Farmer1

  • 1Immunology and Large Molecule Bioanalytical Chemistry, Lovelace Biomedical Research Institute, Albuquerque, NM, USA.

Bioanalysis
|April 16, 2026
PubMed

Keywords:
BioanalysisICH M1LC–MS/MSbiomarker assaysfit-for-purpose assay approachligand-binding assaysmethod validationpharmacokinetic assays

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