کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5857723 | 1132028 | 2011 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Safety evaluation of biological drugs: What are toxicology studies in primates telling us?
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
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چکیده انگلیسی
A total of 26 toxicology studies performed with biological drugs (monoclonal antibodies and related immunoglobulins as well as recombinant human proteins) in the primate have been evaluated to give an insight into the types of study designs used and results. The evaluation involved examination of pivotal repeat dose studies which ranged from 2 to 13Â weeks in duration, used to support early clinical investigation. Either no findings were seen or restricted to those which could largely be explained by the drug's pharmacology. Based on these results and supporting findings from a literature review of other similar drugs in development or approved for marketed use, a case has been made to revisit aspects of the standard design approach of toxicology studies for biological drugs. Thus, consideration should be given to a move away from the use of three drug-treated and numerous non-dose recovery groups currently used to support initial clinical entry to a robust toxicological assessment that could be achieved in many cases with one control and one or two drug-treated groups and with non-dose recovery groups only for the control and highest level used. An argument for not routinely measuring for anti-drug antibodies unless there is a specific drug-related reason is also made.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 59, Issue 2, March 2011, Pages 227-236
Journal: Regulatory Toxicology and Pharmacology - Volume 59, Issue 2, March 2011, Pages 227-236
نویسندگان
Paul Baldrick,