Official International Association for Therapeutic Drug Monitoring and Toxicology guideline: Development and Validation of Dried Blood Spot-based Methods for Therapeutic Drug Monitoring
2019
Abstract: Dried blood spot (DBS) analysis has been introduced
more and more into clinical practice to facilitate Therapeutic Drug
Monitoring (TDM). To assure the quality of bioanalytical methods,
the design, development and validation needs to fit the intended use.
Current validation requirements, described in guidelines for traditional matrices (blood, plasma, serum), do not cover all necessary
aspects of method development, analytical- and clinical validation of
DBS assays for TDM. Therefore, this guideline provides parameters
required for the validation of quantitative determination of small
molecule drugs in DBS using chromatographic methods, and to
provide advice on how these can be assessed. In addition, guidance
is given on the application of validated methods in a routine context.
First, considerations for the method development stage are described
covering sample collection procedure, type of filter paper and punch
size, sample volume, drying and storage, internal standard incorporation, type of blood used, sample preparation and prevalidation.
Second, common parameters regarding analytical validation are
described in context of DBS analysis with the addition of DBSspecific parameters, such as volume-, volcano- and hematocrit
effects. Third, clinical validation studies are described, including
number of clinical samples and patients, comparison of DBS with
venous blood, statistical methods and interpretation, spot quality,
sampling procedure, duplicates, outliers, automated analysis methods and quality control programs. Lastly, cross-validation is
discussed, covering changes made to existing sampling- and analysis
methods. This guideline of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology on the development, validation and evaluation of DBS-based methods for the
purpose of TDM aims to contribute to high-quality micro sampling
methods used in clinical practice.
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