Validation of the statistical parameters and model selection criteria of the benchmark dose methods for the evaluation of various endpoints in repeated-dose toxicity studies

Author:

Matsumoto Mariko1,Hirata-Koizumi Mutsuko1,Kawamura Tomoko1,Sakuratani Sawako1,Ono Atsushi2,Hirose Akihiko1

Affiliation:

1. Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences

2. Division of Pharmaceutical, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University

Publisher

Japanese Society of Toxicology

Reference11 articles.

1. EFSA (2009): SCIENTIFIC OPINION: Use of the benchmark dose approach in risk assessment1 Guidance of the Scientific Committee (Question No EFSA-Q-2005-232) Adopted on 26 May 2009

2. EFSA (2011): TECHNICAL REPORT: Use of BMDS and PROAST software packages by EFSA Scientific Panels and Units for applying the Benchmark Dose (BMD) approach in risk assessment.

3. EPA (2000): Benchmark dose technical guidance document, External Review Draft, EPA/630/R-00/001. Risk Assessment Forum, US Environmental Protection Agency, Washington, DC 20460, October 2000.

4. EPA (2012): Benchmark dose technical guidance, EPA/100/R-12/001, Risk Assessment Forum, US Environmental Protection Agency, Washington DC, June 2012.

5. EPA (2018): Benchmark Dose Software (BMDS) Versuib 3.0 User Guide.

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