| Preclinical safety evaluation of recombinant human interleukin-10. | |
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MedLine Citation:
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PMID: 11846636 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Escherichia coli-derived recombinant human interleukin-10 (rhuIL-10) has been evaluated in an extensive series of in vivo and in vitro nonclinical safety studies, including genetic toxicology, single- and repeat-dose systemic toxicity and toxicokinetics, reproductive toxicity, and specialized irritation studies. The primary test species in the toxicology studies were the mouse and monkey based on rhuIL-10 activity in receptor binding and ex vivo cytokine assays. Supported by a detailed preclinical program of therapeutic and prophylactic animal models in autoimmune diseases, the initial clinical development program has focused on investigating the therapeutic potential of rhuIL-10 (Tenovil) in Crohn's disease and rheumatoid arthritis. The results of the subcutaneous toxicity studies, up to 3 months dosing duration in mice and 6 months dosing duration in monkeys, support the development of rhuIL-10 for present and future clinical indications by the subcutaneous route of administration. |
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Authors:
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I Y Rosenblum; R C Johnson; T J Schmahai |
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Publication Detail:
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Type: Comparative Study; Journal Article |
Journal Detail:
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Title: Regulatory toxicology and pharmacology : RTP Volume: 35 ISSN: 0273-2300 ISO Abbreviation: Regul. Toxicol. Pharmacol. Publication Date: 2002 Feb |
Date Detail:
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Created Date: 2002-02-15 Completed Date: 2002-04-02 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8214983 Medline TA: Regul Toxicol Pharmacol Country: United States |
Other Details:
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Languages: eng Pagination: 56-71 Citation Subset: IM |
Copyright Information:
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© 2002 Elsevier Science (USA). |
Affiliation:
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Safety Evaluation Center, Schering-Plough Research Institute, Lafayette, New Jersey 07848, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Carcinogenicity Tests / methods Dose-Response Relationship, Drug Drug Evaluation, Preclinical Haplorhini Humans Injections, Intravenous Injections, Subcutaneous Interleukin-10 / pharmacokinetics, standards, toxicity* Mice Recombinant Proteins / pharmacokinetics, standards, toxicity* Safety Toxicity Tests / methods* |
| Chemical | |
Reg. No./Substance:
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0/Recombinant Proteins; 130068-27-8/Interleukin-10 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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