Capillary microsampling in nonclinical safety assessment: practical sampling and bioanalysis from a CRO perspective

Bioanalysis
David ColemanJoanna Edwards

Abstract

Microsampling has the 3R benefits of refining blood collection techniques while reducing the number of animals required for rodent safety assessment studies. There are significant scientific benefits of correlating study findings with systemic exposure and consequently, there is an industry drive to utilize microsampling in regulatory toxicology studies. This article will focus on capillary microsampling and will discuss the initial considerations before using capillary microsampling, study design and some practicalities of sample collection. From a bioanalytical perspective, the impact of different sample collection and storage workflows on the design of method validation experiments, the suitability of using microsampling for unstable analytes and aspects supporting analysis of peptides, large molecules and for biomarker applications will be discussed.

References

Sep 23, 2008·Journal of Pharmaceutical Sciences·Sean X PengWilliam Hageman
Nov 19, 2010·Bioanalysis·Gary Emmons, Malcom Rowland
Aug 23, 2011·Regulatory Toxicology and Pharmacology : RTP·Susan S SparrowKathryn L Chapman
Mar 26, 2013·Regulatory Toxicology and Pharmacology : RTP·Kathryn L ChapmanStephen Wilson
Jan 18, 2014·Regulatory Toxicology and Pharmacology : RTP·Nicola Powles-GloverJane Stewart
Jan 23, 2014·Drug Discovery Today·Kathryn ChapmanAmanda Wilson
Aug 28, 2014·Bioanalysis·Philip TimmermanGlen Hawthorne
Oct 30, 2016·Toxicological Sciences : an Official Journal of the Society of Toxicology·Xiaoyu NiuMira Wenker

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Citations

Dec 19, 2019·Bioanalysis·Jason BarricklowRagu Ramanathan
Jun 5, 2020·The Journal of Toxicological Sciences·Hideaki YokoyamaYoshiro Saito

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Methods Mentioned

BETA
blood draws
blood draw
blood

Software Mentioned

NC3Rs
CMS

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