Feedback from a workshop by the European Bioanalysis Forum on assay validation requirements for in vitro assays following the publication of ICH M12 guideline - a plea for context-of-use over ICH M10 standards.
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DOI: 10.1080/17576180.2025.2468596
Abstract: The release of the ICH M12 Guideline on Drug Interaction Studies has reignited discussions around assay validation requirements for in vitro assays such as plasma protein-binding studies. Even though the ICH M12 does not directly… read more here.
Keywords: validation requirements; ich m12; validation; ich m10 ... See more keywords