CPS Attends AAPS Crystal City-V Conference on the FDA Draft Guidance on Bioanalytical Methods Validation
Dr. Larry Mallis, CPS Laboratory Director, attended a 3-day workshop of the American Association of Pharmaceutical Scientists (AAPS) focused on FDA’s recently revised draft guidance on quantitative bioanalytical methods validation, and the implementation of that guidance. The workshop was held to provide a platform for open discussion between industry and the FDA around these topics.
Originally published in 2001, the guidance was revised to demonstrate advances in methods for bioanalytical validation. Since that time, AAPS, in conjunction with the FDA, has held multiple workshops and events that have informed changes made in the new draft guidance. The draft guidance includes new sections, including discussions of endogenous compounds, incurred sample reanalysis, biomarker assays, use of diagnostic kits and new technologies, system suitability, and report formats for tabular data listings. Other text has been updated, such as the sections on chromatography and ligand-binding assays.
One of the significant changes to the guidance is the percent of incurred samples to be reanalyzed (ISR). Previous confusion around this point has led the agency to suggest that a flat 7% of incurred samples be chosen for reanalysis. This was hotly debated due largely in part to the fact that the EMA guidance document (released in 2012) indicated 10% ISR up to 1000 samples, and 5% for sample sets greater than 5%.
AAPS will produce white papers discussing consensus outcomes of the discussions during the presentations related to each section of the new draft guidance. Once these white papers are made available, CPS will provide them as links on our website.
CPS is committed to staying informed of changes to this and other important guidance relating to methods validation. Our full-service, GLP-compliant laboratory can meet trace level detection limits, work within complicated matrices, and achieve quick turn-around times.