Investigation on the Effect of Capillary Microsampling on Hematologic and Toxicokinetic Evaluation in Regulatory Safety Studies in Mice.

The AAPS Journal
Bonnie WangQin C Ji

Abstract

Microsampling techniques enable the minimization of blood collection volume from animals and subsequent handling of the blood samples or their derived plasma or serum samples. This offers advantages over conventional large-volume sampling, such as eliminating the need for satellite animals and improving animal welfare aspects, and providing the opportunity for additional assessments in small animals where blood volume constraints limit endpoints. This study evaluated the feasibility of implementation of capillary microsampling (CMS) in a single-dose study in mice with the ultimate goal of enabling its use in toxicology studies. The focus was on the impact of microsampling on toxicokinetic assessment and on the subsequent hematology assessment in the same animal. A seventy (70)-μL blood collection via CMS from the tail vein had a minimal effect on the hematology parameters of mice (strain C57BL/6) in samples taken within 24 h of blood collection. TK parameters were similar in plasma samples collected via CMS and cardiac puncture sampling. A bioanalytical assay was developed which enabled the quantification of concentration of both the parent drug and a metabolite using only 5-μL plasma sample per analysis. Incurred sample reanal...Continue Reading

References

Feb 17, 2001·Journal of Applied Toxicology : JAT·K H DiehlUNKNOWN European Federation of Pharmaceutical Industries Association and European Centre for the Validation of Alternative Methods
Oct 21, 2011·Bioanalysis·Fumin LiSteve Michael
May 7, 2013·Bioanalysis·Chester L BowenChristopher A Evans
Jan 23, 2014·Drug Discovery Today·Kathryn ChapmanAmanda Wilson
Aug 8, 2014·Journal of Medicinal Chemistry·Joseph B SantellaJohn Hynes
Oct 30, 2016·Toxicological Sciences : an Official Journal of the Society of Toxicology·Xiaoyu NiuMira Wenker
Jan 7, 2017·Journal of Pharmacy & Pharmaceutical Sciences : a Publication of the Canadian Society for Pharmaceutical Sciences, Société Canadienne Des Sciences Pharmaceutiques·Nita J PatelEverett Perkins
Oct 23, 2019·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Amol A RajeVishwottam Kandikere

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Methods Mentioned

BETA
blood collection
Blood Sampling
blood draw
transgenic

Software Mentioned

WinNonlin
Phoenix
Analyst

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