Bioanalytics – Chemical
2019 PharmSci 360
Recently, the International Conference on Harmonization (ICH) released a draft guidance (ICH M10) on Bioanalytical Method Validation (BMV) aimed at harmonizing the requirements for validation and use of bioanalytical methods used for regulatory decision making by member regulatory agencies. This presentation will review comments and discussions from the bioanalytical community pertaining to the chromatographic “analytical run” design and acceptance criteria portions of the draft guidance. Proposed revisions to the text of this and other related sections of the draft guidance document will also be presented.