Bioanalytics – Chemical
2019 PharmSci 360
Earlier this year, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued the draft Harmonised Guideline for Bioanalytical Method validation – the ICH M10 document for public comment. Since then, there have been significant efforts across the bioanalytical community for critical review of the draft ICH M10 document and capture of best practices across the industry. This presentation will cover input from the industry pertaining to the sections on LBA analytical run acceptance criteria, calibration range, sample reanalysis and other considerations.