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Abstract

Aim: Following the request of a regulatory authority, a rat study was conducted to compare pharmacokinetic parameters from traditional large volume sampling and capillary microsampling. Materials & methods: Rats were dosed with a proprietary compound in three dose groups and blood samples were collected via capillary microsampling (32 μl), immediately followed by traditional large volume sampling (300 μl) up to 24 h postdose. Resulting plasma samples were analyzed for parent drug and two metabolites. AUCs were compared between sampling techniques. Results: There was no statistical difference between AUCs from traditional and microsampling across different doses and analytes. Conclusion: Toxicokinetic parameters generated from plasma collected as a capillary microsample or traditional large volume sample are highly comparable.

Keywords:

  • assay validation
  • AUC
  • bridging study
  • capillary microsampling
  • end-to-end capillaries
  • GLP
  • NC3Rs
  • rat studies
  • toxicokinetics
  • toxicology
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