| Literature DB >> 19345250 |
Rafael Ponce1, Leslie Abad, Lakshmi Amaravadi, Thomas Gelzleichter, Elizabeth Gore, James Green, Shalini Gupta, Danuta Herzyk, Christopher Hurst, Inge A Ivens, Thomas Kawabata, Curtis Maier, Barbara Mounho, Bonita Rup, Gopi Shankar, Holly Smith, Peter Thomas, Dan Wierda.
Abstract
An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.Entities:
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Year: 2009 PMID： 19345250 DOI： 10.1016/j.yrtph.2009.03.012
Source DB: PubMed Journal: Regul Toxicol Pharmacol ISSN： 0273-2300 Impact factor: 3.271