2009
DOI: 10.1002/bdrb.20214
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Embryo‐fetal developmental toxicity study design for pharmaceuticals

Abstract: Assessment of potential developmental and reproductive toxicity of human pharmaceuticals is currently guided by the International Conference on Harmonization (ICH) S5(R2) document (available at http://www.ich.org). The studies that assess developmental hazard are generally conducted in rodents and rabbits. Based on the authors' collective experience, adequate designs (including range-finding studies) and the presentation of data for these studies are described in detail. In addition, the suggested initiation a… Show more

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Cited by 54 publications
(31 citation statements)
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“…The mouse is a common mammalian model for embryonic toxicity studies [Bailey et al, 2009;Wise et al, 2009;Khan et al, 2013;Wolff et al, 2013]. Because NP can cross the placental barrier in mammals and can accumulate in embryonic as well as surrounding extra-embryonic tissues, studying their effect on embryos is critical [Chu et al, 2010].…”
Section: Embryonic Toxicity Of Np In Animal Models: Mammalian Embryosmentioning
confidence: 99%
“…The mouse is a common mammalian model for embryonic toxicity studies [Bailey et al, 2009;Wise et al, 2009;Khan et al, 2013;Wolff et al, 2013]. Because NP can cross the placental barrier in mammals and can accumulate in embryonic as well as surrounding extra-embryonic tissues, studying their effect on embryos is critical [Chu et al, 2010].…”
Section: Embryonic Toxicity Of Np In Animal Models: Mammalian Embryosmentioning
confidence: 99%
“…M. Parker 2014a, 2012; R. M. Parker and York 2013; Wise et al 2009; York et al 2014), and juvenile toxicology (Bailey and Mariën 2011; Cappon 2011; Cappon et al 2009; Carleer and Karres 2011; Hurtt 2011; Leconte et al 2011; R. M. Parker 2014b; Rose 2011; Shimomura 2011; Tassinari et al 2011).…”
Section: Opening Remarks and Clinical Regulatory And Toxicology Permentioning
confidence: 99%
“…Additional guidelines address the need and design of juvenile toxicity (from birth until after sexual maturity) studies. Wise's talk detailed the design and types of data collected in the embryo–fetal studies in rodents and rabbits 42 . Although labor intensive, these studies provide the most suitable data for determining risk information for women of childbearing age.…”
Section: Session Vii: Environment Hormone Action and Pharmacologicamentioning
confidence: 99%