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- 615.19005 10
- Drugs -- Analysis -- Periodicals 10
- BAV -- biomarker assay validation -- drug development -- fit-for-purpose validation -- NCI clinical trials -- parallelism -- regulatory considerations 1
- analytical validation -- biomarkers -- clinical trials -- drug development -- early-phase trials 1
- bile acids -- biomarker -- definitive profiling -- human plasma -- liver diseases -- UPLC–high resolution mass spectrometry 1
- biomarker -- Critical Path -- harmonization -- regulations -- validation 1
- biomarker -- biomarker validation -- fit-for-purpose -- intended use 1
- biomarker -- context-of-use -- physiology -- quality control -- regulatory guidance -- statistics -- validation 1
- biomarker -- fit-for-purpose -- ligand-binding assay -- nonregulated bioanalysis -- regulated bioanalysis -- singlicate analysis 1
- biomarker assay validation -- guideline -- Japanese situation 1