Considerations Regarding Nonhuman Primate Use in Safety Assessment of Biopharmaceuticals

被引：22

作者：

Buckley, Lorrene A. ^{[1
]}

Chapman, Kathryn ^{[2
]}

Burns-Naas, Leigh Ann ^{[3
]}

Todd, Marque D. ^{[3
]}

Martin, Pauline L. ^{[4
]}

Lansita, Janice A. ^{[5
]}

机构：

[1] Eli Lilly & Co, Indianapolis, IN 46225 USA

[2] Natl Ctr Replacement Refinement & Reduct Anim Res, London, England

[3] Pfizer Inc, La Jolla, CA USA

[4] Centocor R&D, Radnor, PA USA

[5] US FDA, Silver Spring, MD USA

来源：

INTERNATIONAL JOURNAL OF TOXICOLOGY | 2011年 / 30卷 / 05期

关键词：

nonhuman primate; safety assessment; monoclonal antibodies; biopharmaceuticals; MONOCLONAL-ANTIBODIES; TOXICITY; TOXICOLOGY; TRENDS;

D O I：

10.1177/1091581811415875

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Selection of a pharmacologically responsive species can represent a major challenge in designing nonclinical safety assessment programs for many biopharmaceuticals (eg, monoclonal antibodies (mAbs)). Frequently, the only relevant species for nonclinical testing of mAbs is the non-human primate (NHP). This situation, coupled with a rapidly increasing number of mAb drugs in development, has resulted in a significant increase in the number of NHPs used in nonclinical safety assessment. Apart from ethical considerations related to responsible animal use, there is a clear need for more efficient and innovative approaches to drug discovery and development; these factors drive the need to investigate alternative approaches and strategies for the safety assessment. This review summarizes important scientific and regulatory perspectives derived from presentations and audience discussions in an educational forum at the 2010 annual American College of Toxicology meeting regarding opportunities for employing alternative approaches to minimize NHP use in mAb drug development.

引用

页码：583 / 590

页数：8

共 30 条

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