Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5858569 | Reproductive Toxicology | 2014 | 15 Pages |
Abstract
Preclinical imaging technologies are increasingly being applied to developmental toxicology studies in drug development to determine potential compound toxicity. Although most of these studies are conducted in a non-regulatory setting, there is interest in performing these imaging studies under applicable regulations, for example Good Laboratory Practices (GLP), to support regulatory decisions concerning drug safety. This manuscript will describe regulations and processes to consider when bringing an imaging technology into GLP compliance.
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Authors
Colena A. Johnson, Christopher T. Winkelmann, L. David Wise,