کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5857899 | 1132056 | 2009 | 19 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
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چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 54, Issue 2, July 2009, Pages 164-182
Journal: Regulatory Toxicology and Pharmacology - Volume 54, Issue 2, July 2009, Pages 164-182
نویسندگان
Rafael Ponce, 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,