Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies
| Autor: | Curtis Maier, James Green, Holly W. Smith, Dan Wierda, Gopi Shankar, Danuta J. Herzyk, Inge A. Ivens, Shalini Gupta, Leslie Abad, Lakshmi Amaravadi, Bonita Rup, Thomas Gelzleichter, Peter Thomas, Christopher Hurst, Rafael A. Ponce, Elizabeth R. Gore, Thomas T. Kawabata, Barbara Mounho |
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| Rok vydání: | 2009 |
| Předmět: |
Dose-Response Relationship
Drug business.industry Drug Administration Routes Immunogenicity Drug Evaluation Preclinical Data interpretation Nonclinical safety General Medicine Pharmacology Toxicology Bioinformatics Drug Administration Schedule Recombinant Proteins Biopharmaceutics Species Specificity Data Interpretation Statistical Antibody Formation Toxicity Tests Animals Humans Medicine business Toxicity profile Clinical evaluation Antibody formation |
| Zdroj: | Regulatory Toxicology and Pharmacology. 54:164-182 |
| ISSN: | 0273-2300 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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