Perspectives on updates, clarifications and controversies in chromatographic assay guidance for bioanalytical method validation from major regulatory agencies and organizations

Abstract

Bioanalysis, a key supporting function for generating data for pre-clinical and clinical studies in drug development, is under the regulation of local agencies as well as global organizations to ensure the data integrity and quality in submission. As major regulatory agencies and organizations, the US Food and Drug Administration, the European Medicines Agency and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use have been updating their industry guidance for bioanalytical method validation, to keep up with the development new modalities, technologies and regulations. This article summarizes the recent updates and any clarifications and controversies triggered by those updates. Perspectives and recommendations are given based on our own experience as well as commonly accepted practice in the bioanalytical community.

Bioanalytical Methods for Poly(ADP-Ribose) Polymerase Inhibitor Quantification: A Review for Therapeutic Drug Monitoring

“…The reason for this heterogeneity might be the complexity of ME evaluation, as already pointed out in a recent perspective article. 67 Most of the reviewed studies [13][14][15]17,[19][20][21] used the postextraction method, 68 which requires evaluation from 6 different matrices at high and low concentrations. Some of these studies used more levels of concentration 19 or less than 6 matrices 15 or did not specify these details, 14,19 but their rationales remained the same.…”