Innovation and regulatory science play key roles in the implementation of novel and emerging technologies for standard-setting activities such as the development of performance characteristics, testing methodology, and manufacturing practices for regulatory purposes. The bio-analytical and advanced analytical team at OPQ/OTR/DPQR is a primary regulatory science resource within FDA/CDER and is dedicated to developing and implementing validated methods to quantitate therapeutic drugs and their metabolites in complex biological matrixes, such as plasma, tissue and IVPT receptor media, to support pre-clinical and clinical biopharmaceutics. The presentation will highlight two case studies to illustrate how the team successfully developed, validated and implemented analytical methods using an automated sample delivery system coupled with tandem mass spectrometry to investigate the quality of narrow therapeutic index and OTC drug products. In addition, the team considers life cycle improvement of the fit-for-purposes analytical methods as an iterative process to ensure methods robustness and meet the evolving regulatory science requirements.<br/>

Module-based method development and life cycle method improvement: Two case studies of complex method development, validation, and implementation using automated tandem mass spectrometry to support regulatory science issues

2019 Fall National Meeting

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