Evidence map›Paper›PMID 32152888›Full record

ArticleThe AAPS journal2020

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

Bonnie Wang, Linna Wang, Alicja Batog, Thomas Brodie, Lila Ramaiah, Kristina D Chadwick, Ting Su, Raja Mangipudy, Renuka C Pilutla, Qin C Ji

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Clinical Chemistry for Developing Countries: Mass Spectrometry.Annual review of analytical chemistry (Palo Alto, Calif.) · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Bonnie WangDrug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
Linna WangBioanalytical Science, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA.
Alicja BatogDrug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
Thomas BrodieDrug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
Lila RamaiahDrug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
Kristina D ChadwickDrug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
Ting SuDrug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
Raja MangipudyDrug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, New Jersey, 08903, USA.
Renuka C PilutlaBioanalytical Science, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA.
Qin C JiBioanalytical Science, Bristol-Myers Squibb, Princeton, New Jersey, 08543, USA. qin.ji@bms.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 reanalysis (ISR), unexpected event investigation, and re-assay were successfully performed on the limited samples (≤ 20 μL) collected from CMS. The results of this study confirmed the feasibility of implementing CMS in regulated mouse toxicity studies and demonstrated that it is possible to eliminate or reduce satellite animals.

Indexed as

Blood Specimen CollectionHematologic TestsToxicity TestsAdministration, OralAnimalsErythrocyte CountErythrocytesFeasibility StudiesHematocritHemoglobinsMice, Inbred C57BLTailToxicokineticsUreaValineWorkflow1-(1-(4-(4-chlorophenyl)-4-hydroxy-3,3-dimethylpiperidin-1-yl)-3-methyl-1-oxobutan-2-yl)-3-(2-hydroxy-2-methylpropyl)ureaHemoglobinsUreaValinecapillary microsamplinghematologymouse toxicology studytoxicokinetic

Identifiers

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.