Critical reagents are an essential part of bioanalytical testing for large molecule preclinical and clinical studies. These essential components help determine the accuracy of the analyte, precision and performance of ligand binding assays (LBAs), which are key to...
ICH M10 Guidance
ICH M10: Preview New Bioanalytical Method Validation Guidance
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is in the process of revising M10, a multidisciplinary guideline that governs bioanalytical method validation. Drugs need to contain the correct...