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Long-term Behavioral and Reproductive Consequences of Embryonic Exposure to Low-dose Toxicants
Published on: March 6, 2018
Pregnancy exposure registries: academic opportunities and industry responsibility
1Amgen Inc, Global Regulatory Affairs and Safety, One Amgen Center Drive, Thousand Oaks, California 91320, USA. diegow@amgen.com
Abstract:
Pregnancy exposure registries systematically evaluate pregnancies and outcomes exposed to a medicinal compound or device during the gestational period. Historically, such programs partner an academic institution with one or more pharmaceutical companies or are run solely by a pharmaceutical company. However, other examples abound. This article describes what a pregnancy exposure registry is, as well as selected methodological challenges they face, using real examples and applications.
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