Official International Association for Therapeutic Drug Monitoring and Clinical Toxicology Guideline: Development and Validation of Dried Blood Spot-Based Methods for Therapeutic Drug Monitoring
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 i...
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| Vydané v: | Therapeutic drug monitoring Ročník 41; číslo 4; s. 409 |
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| Hlavní autori: | , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
| Vydavateľské údaje: |
United States
01.08.2019
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| Predmet: | |
| ISSN: | 1536-3694, 1536-3694 |
| On-line prístup: | Zistit podrobnosti o prístupe |
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| 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 DBS-specific 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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| AbstractList | 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 DBS-specific 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. 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 DBS-specific 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.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 DBS-specific 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. |
| Author | Alffenaar, Jan-Willem C Bergqvist, Yngve Halmingh, Otto Stove, Christophe P Keevil, Brian G Koster, Remco A Linden, Rafael Koch, Birgit C P Boettcher, Michael Pistos, Constantinos Stolk, Leo M Touw, Daan J Veenhof, Herman Capiau, Sara |
| Author_xml | – sequence: 1 givenname: Sara surname: Capiau fullname: Capiau, Sara organization: Laboratory of Toxicology, Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium – sequence: 2 givenname: Herman surname: Veenhof fullname: Veenhof, Herman organization: Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands – sequence: 3 givenname: Remco A surname: Koster fullname: Koster, Remco A organization: PRA Health Sciences, Bioanalytical Laboratory, Assen, the Netherlands – sequence: 4 givenname: Yngve surname: Bergqvist fullname: Bergqvist, Yngve organization: Professor Emeritus, Dalarna University College, Borlänge, Sweden – sequence: 5 givenname: Michael surname: Boettcher fullname: Boettcher, Michael organization: MVZ Labor Dessau GmbH, Dessau-Roßlau, Germany – sequence: 6 givenname: Otto surname: Halmingh fullname: Halmingh, Otto organization: Spark Holland BV, Emmen, the Netherlands – sequence: 7 givenname: Brian G surname: Keevil fullname: Keevil, Brian G organization: Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom – sequence: 8 givenname: Birgit C P surname: Koch fullname: Koch, Birgit C P organization: Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands – sequence: 9 givenname: Rafael surname: Linden fullname: Linden, Rafael organization: Laboratory of Analytical Toxicology, Institute of Health Sciences, Universidade Feevale, Novo Hamburgo, Brazil – sequence: 10 givenname: Constantinos surname: Pistos fullname: Pistos, Constantinos organization: Department of Chemistry, West Chester University, West Chester, Pennsylvania – sequence: 11 givenname: Leo M surname: Stolk fullname: Stolk, Leo M organization: Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre, Maastricht, the Netherlands – sequence: 12 givenname: Daan J surname: Touw fullname: Touw, Daan J organization: Department of Pharmaceutical Analysis, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands – sequence: 13 givenname: Christophe P surname: Stove fullname: Stove, Christophe P organization: Laboratory of Toxicology, Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium – sequence: 14 givenname: Jan-Willem C surname: Alffenaar fullname: Alffenaar, Jan-Willem C organization: Westmead Hospital, Sydney, Australia |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31268966$$D View this record in MEDLINE/PubMed |
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| PublicationPlace | United States |
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| PublicationTitle | Therapeutic drug monitoring |
| PublicationTitleAlternate | Ther Drug Monit |
| PublicationYear | 2019 |
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| Snippet | Dried blood spot (DBS) analysis has been introduced more and more into clinical practice to facilitate Therapeutic Drug Monitoring (TDM). To assure the quality... |
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| SubjectTerms | Dried Blood Spot Testing - methods Dried Blood Spot Testing - standards Drug Monitoring - methods Drug Monitoring - standards Humans Reproducibility of Results Specimen Handling - methods Specimen Handling - standards |
| Title | Official International Association for Therapeutic Drug Monitoring and Clinical Toxicology Guideline: Development and Validation of Dried Blood Spot-Based Methods for Therapeutic Drug Monitoring |
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