Therapeutic Drug Monitoring: April 2016 – Volume 38 – Issue 2 – p 170–189
Seger, Christoph PhD; Shipkova, Maria MD; Christians, Uwe MD, PhD; Billaud, Elaine M. PharmD, PhD; Wang, Ping PhD; Holt, David W. DSc (Med); Brunet, Mercè PhD; Kunicki, Paweł K. PhD; Pawiński, Thomasz PhD; Langman, Loralie J. PhD; Marquet, Pierre MD, PhD; Oellerich, Michael MD; Wieland, Eberhard MD; Wallemacq, Pierre PhD
Abstract: This overview is intended to serve as a summary and guidance document describing the current state-of-the-art in the TDM of ISDs. The recommendations address all phases of the analytical procedure life cycle, including method design, method validation and performance verification; the definition of appropriate acceptance criteria for analytical performance; risk assessment; and method life cycle management. Regarding validation, a proposal on how to adapt the recognized guidelines published by international scientific societies and governmental agencies, for the analysis of ISDs, has been provided. Both specifics related to LDT and commercial tests at the analytical site are covered. Actions aimed at improving the consistency of the reported results (including between-method, between-laboratory, and over time consistency) have the highest priority.
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