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- Publisher
- John Wiley & Sons, Inc.
- Copyright
- Copyright © 2010 John Wiley & Sons, Inc. All rights reserved.
- ISBN
- 9780470571224
- Pages
- 1–25
- DOI
- 10.1002/9780470571224.pse168
- Publisher site
- See Chapter on Publisher Site
Abstract
[ Abstract It is important to select a relevant species for conducting safety assessment studies to mimic putative interpatient treatment differences in test article responsiveness and understand the rank order pharmacologic sensitivity of the relevant common laboratory animal species. Appropriate selection of a pharmacologically relevant species will also enable identification of factors that affect the therapeutic index of biopharmaceutical. This article discusses various experimental approaches used to select the relevant species for conduct of toxicology studies for biopharmaceuticals and advances made in scientific approaches to facilitate this process. ]
Published: Mar 15, 2010
Keywords: species selection; biologics; toxicology studies; in vivo pharmacodynamic effect; transcript profiling; in silico analysis