Bioanalytics – Chemical
2019 PharmSci 360
The International Conference on Harmonization (ICH) was established to develop guidance documents acceptable to all member regulatory agencies. As part of the activities of ICH, a draft guidance (M10) on Bioanalytical Method Validation has recently been issued. This presentation will review comments from the bioanalytical pertaining to the sections of the draft dealing with scope and documentation. Suggested revisions to these sections that have been developed by the bioanalytical community will be discussed.