The authors are part of the Biotechnology Industry Organization's (BIO) juvenile toxicity studies for biotherapeutics taskforce. This taskforce is a committee within the BioSafe Preclinical Safety Committee, comprised of BIO members working to serve as a resource for BIO members and BIO staff by identifying and responding to key scientific and regulatory issues related to the preclinical safety evaluation of biopharmaceuticals products.
Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices†
Article first published online: 18 JUL 2011
© 2011 Wiley-Liss, Inc.
Birth Defects Research Part B: Developmental and Reproductive Toxicology
Volume 92, Issue 4, pages 359–380, August 2011
How to Cite
Morford, L. L., Bowman, C. J., Blanset, D. L., Bøgh, I. B., Chellman, G. J., Halpern, W. G., Weinbauer, G. F. and Coogan, T. P. (2011), Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices. Birth Defects Research Part B: Developmental and Reproductive Toxicology, 92: 359–380. doi: 10.1002/bdrb.20305
- Issue published online: 19 AUG 2011
- Article first published online: 18 JUL 2011
- Manuscript Received: 11 APR 2011
- Manuscript Accepted: 11 APR 2011
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