Bioanalytical HPLC Method Development: ICH M10 Practical Guide
Bioanalytical HPLC method development creates a fit-for-purpose procedure to measure a drug, metabolite or biomarker in a defined biological matrix. For nonclinical and clinical drug studies, the FDA-adopted ICH M10 guideline provides harmonised recommendations for method validation and study-sample analysis. This practical guide outlines how to define the assay, develop sample preparation and chromatography, validate […]
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