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The application of capillary microsampling in GLP toxicology studies
Tom Verhaeghe1, Lieve Dillen1, Hans Stieltjes1
1Development Bioanalysis, Janssen Research & Development, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.
Bioanalysis
|March 17, 2017
Summary
Capillary microsampling (CMS) significantly reduces rat blood collection volumes in toxicology studies, from 300 to 32 µl. This advancement eliminates the need for toxicokinetic satellite groups, streamlining study designs.
Area of Science:
- Toxicology and Pharmacology
- Analytical Chemistry
Background:
- Traditional blood sampling in rat GLP studies requires large volumes (300 µl).
- This necessitates the use of toxicokinetic satellite groups, increasing animal usage.
- Capillary microsampling (CMS) offers a minimally invasive alternative.
Purpose of the Study:
- To evaluate the implementation and impact of CMS in Good Laboratory Practice (GLP) toxicology studies.
- To assess the reduction in blood volume and its effect on study design.
Main Methods:
- Blood samples (approx. 32 µl) collected via CMS using capillaries.
- Plasma processed and stored in 10- or 4-µl capillaries.
- Standardization of CMS materials, assay validation, and sample analysis.
Main Results:
- Reduced rat blood volume from 300 µl to 32 µl per time point.
- Eliminated toxicokinetic satellite groups in most rat GLP studies.
- Successfully applied in 26 GLP studies across 12 projects.
Conclusions:
- CMS is a validated and effective technique for rat toxicology studies.
- Significant reduction in animal blood volume and improved study efficiency.
- CMS implementation streamlines GLP studies and reduces ethical burden.
