With the recent adoption of the ICH M10 guidelines, the discussion shifts to the implementation of this latest technical document (Step 5). The ICH M10 provides recommendations on how to validate a bioanalytical assay for drug quantification and how to apply the validation during study sample analysis.

Our discussion involves the documentation aspect of writing the method validation and sample analysis reports used to make regulatory decisions and the tools – such as StudyDoc – we use to adapt to this changing environment.