Toward Analytical Performance Specifications for Immunosuppressive Drug Quantification in Transplantation: An Opinion Article

There is no single ideal approach for setting goals of drug analysis. However, the pCV A % values derived from the various approaches are similar and confirm that a <6% target proposed by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology is adequate and realistic in combination with state-of-the-art measurement technologies. In the authors' opinion, approaches based on the width of the TR are preferable, as they represent a common basis for clinical decisions and reflect elements of biological variation and analytics used to establish the TR.