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Critical Reviews in Toxicology Volume 47, 2017 - Issue 5
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Review Articles

Comparing rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on systemic dose and developmental effects

Peter T. TheunissenCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands; ;Medicines Evaluation Board, Utrecht, The Netherlands; ;Innovative Testing in Life Sciences and Chemistry, University of Applied Sciences Utrecht (HU), Utrecht, The Netherlands; Correspondence[email protected]
,
Sonia BekenFederal Agency for Medicines and Health Products, Brussels, Belgium;
,
Bruce BeyerSanofi U.S. Inc, Bridgewater, NJ, USA;
,
William J. BreslinLilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA;
,
Gregg D. CapponPfizer Worldwide Research & Development, Groton, CT, USA;
,
Connie L. ChenILSI-Health and Environmental Sciences Institute, Washington, DC, USA;
,
Gary ChmielewskiCovance Laboratories Inc, Greenfield, IN, USA;
,
Luc de SchaepdrijverPreclinical Development & Safety, Beerse, Belgium;
,
Brian EnrightAbbVie Inc, North Chicago, IL, USA;
,
Jennifer E. ForemanExxonMobil Biomedical Sciences, Inc, Annandale, NJ, USA;
,
Wafa HarroukUS Food & Drug Administration, Silver Spring, MD, USA;
,
Kok-Wah HewTakeda Pharmaceutical Company, Deerfield, IL, USA;
,
Alan M. HobermanPreclinical Services, Charles-River Laboratories, Horsham, PA, USA;
,
Julia Y. HuiCelgene Corporation, Summit, NJ, USA;
,
Thomas B. KnudsenUS Environmental Protection Agency, National Center for Computational Toxicology, Research Triangle Park, NC, USA;
,
Susan B. LaffanSafety Assessment, GlaxoSmithKline, King of Prussia, PA, USA;
,
Susan L. MakrisNational Center for Environmental Assessment, US Environmental Protection Agency, Washington, DC, USA;
,
Matthew MartinUS Environmental Protection Agency, National Center for Computational Toxicology, Research Triangle Park, NC, USA;
,
Mary Ellen McNerneyDrug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, NJ, USA;
,
Christine L. SiezenMedicines Evaluation Board, Utrecht, The Netherlands;
,
Dinesh J. StanislausSafety Assessment, GlaxoSmithKline, King of Prussia, PA, USA;
,
Jane StewartDrug Safety & Metabolism, AstraZeneca, Macclesfield, UK;
,
Kary E. ThompsonDrug Safety Evaluation, Bristol-Myers Squibb, New Brunswick, NJ, USA;
,
Belen TornesiAbbVie Inc, North Chicago, IL, USA;
,
Jan Willem Van der LaanCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands; ;Medicines Evaluation Board, Utrecht, The Netherlands;
,
Gerhard F. WeinbauerCovance Preclinical Services GmbH, Muenster, Germany;
,
Sandra WoodMerck Research Laboratories, Upper Gwynedd, PA, USA;
&
Aldert H. PiersmaCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands; ;Faculty of Veterinary Sciences, Institute for Risk Assessment Sciences, Utrecht University, Utrecht, The Netherlands
 show all
Pages 409-421 | Received 09 Feb 2016, Accepted 11 Aug 2016, Published online: 21 Oct 2016

References

  • FDA. 2005. Guidance for industry: estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Fed Register 70(140):42346.
  • Hurtt ME, Cappon GD, Browning A. 2003. Proposal for a tiered approach to developmental toxicity testing for veterinary pharmaceutical products for food-producing animals. Food Chem Toxicol. 41:611–619.
  • ICH. 2005. ICH harmonised tripartite guideline: detection of toxicity of reproduction for medicinal products and toxicity to male fertility S5(R2). Available from: http://www.ich.org/products/guidelines/safety/safety-single/article/detection-of-toxicity-to-reproduction-for-medicinal-products-toxicity-to-male-fertility.html
  • Janer G, Slob W, Hakkert BC, Vermeire T, Piersma AH. 2008. A retrospective analysis of developmental toxicity studies in rat and rabbit: what is the added value of the rabbit as an additional test species? Regul Toxicol Pharmacol. 50:206–217.
  • Knudsen TB, Martin MT, Kavlock RJ, Judson RS, Dix DJ, Singh AV. 2009. Profiling the activity of environmental chemicals in prenatal developmental toxicity studies using the U.S. EPA's ToxRefDB. Reprod Toxicol. 28:209–219.
  • Loebstein R, Lalkin A, Koren G. 1997. Pharmacokinetic changes during pregnancy and their clinical relevance. Clin Pharmacokinet. 33:328–343.
  • Makris SL, Solomon HM, Clark R, Shiota K, Barbellion S, Buschmann J, Ema M, Fujiwara M, Grote K, Hazelden KP, et al. 2009. Terminology of developmental abnormalities in common laboratory mammals (Version 2). Birth Defects Res Part B Develop Reprod Toxicol. 86:227–327.
  • Martin MT, Judson RS, Reif DM, Kavlock RJ, Dix DJ. 2009. Profiling chemicals based on chronic toxicity results from the U.S. EPA ToxRef Database. Environ Health Perspect. 117:392–399.
  • OECD. 2001. OECD guideline for the testing of chemicals, no. 414: prenatal developmental toxicity study. Paris, France: Organization for Economic Cooperation and Development.
  • Schardein J. 2000. Chemically induced birth defects. New York: Marcel Decker Inc.
  • Theunissen PT, Beken S, Beyer BK, Breslin WJ, Gappon GD, Chen CL, Chmielewski G, De Schaepdrijver L, Enright B, Foreman JE, et al. 2016. Comparison of rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on the nature and severity of developmental effects. Criti Rev Toxicol. [Epub ahead of print]. doi: 10.1080/10408444.2016.1224807.
  • Theunissen PT, Beken S, Cappon GD, Chen C, Hoberman AM, van der Laan JW, Stewart J, Piersma AH. 2014. Toward a comparative retrospective analysis of rat and rabbit developmental toxicity studies for pharmaceutical compounds. Reprod Toxicol. 47:27–32.

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