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Expert Opinion on Drug Safety Volume 11, 2012 - Issue 5
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Thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance?

Marlous KooijmanUtrecht University, Copernicus Institute of Sustainable Development, Innovation studies, Heidelberglaan 2, postbus 80115, 3508 TC, Utrecht, The Netherlands+31 30 253 6771; +31 30 251 2746; [email protected]
,
Peter J.K. van MeerUtrecht University, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Department of Pharmaceutics, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands
,
Ellen H.M. MoorsUtrecht University, Copernicus Institute of Sustainable Development, Innovation studies, Heidelberglaan 2, postbus 80115, 3508 TC, Utrecht, The Netherlands+31 30 253 6771; +31 30 251 2746; [email protected]
&
Huub SchellekensUtrecht University, Copernicus Institute of Sustainable Development, Innovation studies, Heidelberglaan 2, postbus 80115, 3508 TC, Utrecht, The Netherlands+31 30 253 6771; +31 30 251 2746; [email protected];Utrecht University, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Department of Pharmaceutics, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands
Pages 797-801 | Published online: 06 Aug 2012

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