Bioanalytics – Chemical
2019 PharmSci 360
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued draft ICH M10 document to present updated recommendations on Bioanalytical methods validation and sample analysis. The aim of the presentation will be to review comments related to the ICH M10 guideline considerations on Ligand Binding Assay (LBA) method validation and related stability requirements. Critical industry observations and experiences as discussed within the community of practice will be presented.