Abstract
The characteristics of biologic drugs, as compared with small molecules, confer significant advantages for both the drug developer and the prospective patients. The necessity for, and the timing of, developmental toxicity testing in the preclinical program must be considered. Choice of an appropriate test system is of particular importance, one that shows pharmacodynamic activity comparable to man. Where the conventional rodent/non-rodent species show such functional cross-reactivity, those species can be used in developmental testing, but often the only relevant species will be a nonhuman primate, in which case an extended study design (the ePPND) should be the default. Such an approach provides appropriate toxicity screening while reducing animal usage.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
ICH (2011) ICH guideline S6 (R1)—preclinical safety evaluation of biotechnology-derived pharmaceuticals. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002828.pdf. Accessed 24 Aug 2011
ICH (2005) ICH harmonised tripartite guideline detection of toxicity to reproduction for medicinal products & toxicity to male fertility S5(R2). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S5_R2/Step4/S5_R2__Guideline.pdf. Accessed 24 Aug 2011
Cavagnaro JA (2008) Preclinical safety evaluation of biopharmaceuticals. Wiley, Hoboken
Stewart J (2009) Developmental toxicity testing of monoclonal antibodies: an enhanced pre- and postnatal study design option. Reprod Toxicol 28:220–225
Grote-Wessels S et al (2010) Immunotoxicity testing in nonhuman primates. In: Dietert R (ed) Immunotoxicity testing: methods and protocols. Springer, New York, pp 341–359
Pentsuk N, van der Laan JW (2009) An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol 86:328–344
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer Science+Business Media, LLC
About this protocol
Cite this protocol
Hazelden, K.P. (2013). The Developmental Toxicity Testing of Biologics. In: Barrow, P. (eds) Teratogenicity Testing. Methods in Molecular Biology, vol 947. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-62703-131-8_3
Download citation
DOI: https://doi.org/10.1007/978-1-62703-131-8_3
Published:
Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-62703-130-1
Online ISBN: 978-1-62703-131-8
eBook Packages: Springer Protocols