The adoption of ICH M10 will introduce several operational changes in the regulated bioanalytical laboratory. While most of these changes are minor, depending upon the stage of development for a drug discovery program, they will need to be incorporated into the bioanalytical assay for future sample analysis. Among these changes are significant differences in the handling of dilution QCs during sample analysis, alterations to the placement of the mid-level QC in the analytical range, universal adoption of multi-aliquot stability QCs and specific instructions for validation experiment requirements for co-administered compounds. None of these changes represents major alterations to the bioanalytical assay; however, any change to a regulated method will warrant consideration and likely some level of validation. If additional validation is required, a priori acceptance criteria need to be established to demonstrate that the changes to the method to bring it into compliance with the ICH M10 guidance do not impact the integrity of the previously collected data or the integrity of any upcoming analysis.
About the Presenter
Dr. Jennifer Zimmer is the Laboratory Director at Alturas Analytics, Inc. and has been working in the field of bioanalysis for over 20 years. She received her B.A. degree in English and Zoology from the University of Idaho and her Ph.D. in Pharmacology from the University of Colorado Health Sciences Center, working in Dr. Robert Murphy’s laboratory on the leukotriene lipid mediator pathway. Her post-doctoral experience in Dr. Richard Smith’s laboratory focused on using metabolomics to elucidate disease pathways and to discover novel biomarker targets.
Dr. Zimmer is responsible for the overall operation of the Alturas Analytics laboratory. She has experience with FTICR, TOF, ion trap and quadrupole instrumentation. She has utilized these instruments for quantitation as well as structure elucidation using HPLC-MS/MS and HPLC-MSn. She oversees the scientific staff and ensures that client deliverables are met while working laterally with the Alturas Analytics, Inc. QAU in order to maintain laboratory compliance with all procedures and regulations. Dr. Zimmer is an active participant the Global CRO Council (GCC) and a member of the American Society for Mass Spectrometry.
