Lack of toxicological influences by microsampling (50 µL) from jugular vein of rats in a collaborative 28-day study
Author:
Affiliation:
1. Japan Tobacco Inc.
2. Ajinomoto Co., Inc.
3. Axcelead Drug Discovery Partners Inc.
4. LSI Medience Co.
5. National Institute of Health Sciences
Publisher
Japanese Society of Toxicology
Subject
Toxicology
Link
https://www.jstage.jst.go.jp/article/jts/45/6/45_319/_pdf
Reference7 articles.
1. Caron, A., Lelong, C., Bartels, T., Dorchies, O., Gury, T., Chalier, C. and Benning, V. (2015): Clinical and anatomic pathology effects of serial blood sampling in rat toxicology studies, using conventional or microsampling methods. Regul. Toxicol. Pharmacol., 72, 429-439.
2. Coleman, D., Smith, G., Lawrence, R., McManus, D., Diaram, S. and Edwards, J. (2017): Capillary microsampling in nonclinical safety assessment: practical sampling and bioanalysis from a CRO perspective. Bioanalysis, 9, 787-798.
3. Diehl, K.H., Hull, R., Morton, D., Pfister, R., Rabemampianina, Y., Smith, D., Vidal, J.M. and van de Vorstenbosch, C.; European Federation of Pharmaceutical Industries Association and European Centre for the Validation of Alternative Methods. (2001): A good practice guide to the administration of substances and removal of blood, including routes and volumes. J. Appl. Toxicol., 21, 15-23.
4. ICH. (1994): ICH S3A: Note for guidance on toxicokinetics: The assessment of systematic exposure in toxicity studies. (https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S3A/Step4/S3A_Guideline.pdf)
5. ICH. (2017): ICH S3A Q&A focus on microsampling. (https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S3A/S3AIWG_Step4_2017_1116.pdf).
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