Approaches of validation of a 2-week combined repeated oral dose toxicity study with plasma micro sampling toxicokinetics (PMS-TK) in common marmosets-Reference-Cited by-同舟云学术

Approaches of validation of a 2-week combined repeated oral dose toxicity study with plasma micro sampling toxicokinetics (PMS-TK) in common marmosets

Published:2018 Issue:11 Volume:43 Page:685-695
ISSN:0388-1350
Container-title:The Journal of Toxicological Sciences
language:en
Short-container-title:J. Toxicol. Sci.

Author:

Mochizuki Hidemi¹,Murota Naoya¹,Sato Shin-ichi¹,Nii Kazuo²,Kouhei Yoko²,Taniguchi Masahiro²,Inoue Ryo³,Nishime Chiyoko³,Tsutsumi Hideki³

Affiliation:

1. Ina Research Inc.

2. Sumika Chemical Analysis Service, Ltd.

3. Central Institute for Experimental Animals

Publisher

Japanese Society of Toxicology

Subject

Toxicology

Link

https://www.jstage.jst.go.jp/article/jts/43/11/43_685/_pdf

Reference18 articles.

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2. 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.

3. David, J.M., Dick, E.J. Jr. and Hubbard, G.B. (2009): Spontaneous pathology of the common marmoset (Callithrix jacchus) and tamarins (Saguinus oedipus, Saguinus mystax). J. Med. Primatol., 38, 347-359.

4. FDA. (1996): NDA#020665, Review and evaluation of pharmacology and toxicology data. (https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020665_s000.pdf)

5. ICH. (2009): Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3(R2).

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