Head-To-Head Comparison of Dried Blood Spots and Traditional Plasma Pk Sampling In a Clinical Trial

David Pekar, Department of Analytical Chemistry, Recipharm, Uppsala, Sweden (david.pekar@recipharm.com)

Volumetric absorption microsampling (VAMS) dried blood spots PK samples were evaluated against traditional venous plasma samples in a clinical trial. The aim of this study was the comparison data from the two sampling techniques in a real world environment and a large data set.

The developed VAMS LC-MS/MS method was validated according to EMA and FDA guidelines. Duplicate DBS PK samples as well as one plasma sample was taken at each PK time point at the clinical center during the trial. More than 800 individual PK time points were extracted and analysed, resulting in a data set of more than 2400 samples spanning both sampling techniques. The reproducibility of the PK data obtained from the two DBS samples were very good and fulfilled the acceptance criteria used for the incurred sample reanalysis (ISR) test needed for the acceptance of bioanalytical data from a clinical trial according to EMA and FDA. A direct comparison of the results of the two different sampling techniques is presented.

Experiences and practicalities from working with the DBS in a clinical trial environment as well as from the bioanalytical phase are discussed.

 

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Short Biography of Presenting Author

My name is David Pekar and I am the GLP/GCLP Test Site Manager of the bioanalytical laboratory of Recipharm in Uppsala, Sweden. I have worked within the field of analytical chemistry since 1998 with an emphasis on using chromatographic systems coupled to mass spectrometry. I entered the field of bioanalysis in 2001 when I joined Quintiles Phase I facility in Uppsala, Sweden. Since that time I have gained experience from working in three different GLP/GCP regulated bioanalytical laboratories.

I am currently the GLP Test Site Manager at the Recipharm bioanalytical laboratory and am also responsible for implementing new analytical technologies and strategies at our Recipharm Development site.