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Transgenic Animals

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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

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Abstract

Safety pharmacology studies are defined as:

“Those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.” (ICH S7A International Guidelines on Safety Pharmacology Studies; Anon 2001)

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Authors and Affiliations

  1. Safety Pharmacology Department, Global Safety Assessment, AstraZeneca R&D, Alderley Park, Cheshire, United Kingdom

    Dr. Will S. Redfern & Jean-Pierre Valentin

Authors
  1. Dr. Will S. Redfern
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  2. Jean-Pierre Valentin
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Corresponding author

Correspondence to Will S. Redfern .

Editor information

Editors and Affiliations

  1. Sanofi Pharma Deutschland GmbH, A company of the Sanofi-Aventis Group Industriepark Hoechst, Frankfurt am Main, Germany

    Jochen Maas

  2. Dieburg, Germany

    Franz J. Hock

  3. Idstein, Germany

    Dieter Mayer

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Redfern, W.S., Valentin, JP. (2013). Transgenic Animals. In: Vogel, H.G., Maas, J., Hock, F.J., Mayer, D. (eds) Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-25240-2_21

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