The design of chronic toxicology studies of monoclonal antibodies: Implications for the reduction in use of non-human primates-Reference-Cited by-同舟云学术

The design of chronic toxicology studies of monoclonal antibodies: Implications for the reduction in use of non-human primates

Published:2012-03 Issue:2 Volume:62 Page:347-354
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Chapman Kathryn L.,Andrews Laura,Bajramovic Jeffrey J.,Baldrick Paul,Black Lauren E.,Bowman Christopher J.,Buckley Lorrene A.,Coney Lee A.,Couch Jessica,Maggie Dempster A.,de Haan Lolke,Jones Keith,Pullen Nick,de Boer Anne Seitske,Sims Jennifer,Ian Ragan C.

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference11 articles.

1. Spending on new drug development;Adams;Health Economics,2010

2. Safety evaluation of biological drugs: what are toxicology studies in primates telling us?;Baldrick;Regul. Toxicol. Pharmacol.,2011

3. Preclinical safety testing of monoclonal antibodies: the significance of species relevance;Chapman;Nat. Rev. Drug Discov.,2007

4. Preclinical development of monoclonal antibodies: considerations for the use of non-human primates;Chapman;mAbs,2009

5. The future of non-human primate use in mAb development;Chapman;Drug Discov. Today,2010

Cited by 52 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. The use of weight-of-evidence approaches to characterize developmental toxicity risk for therapeutic monoclonal antibodies in humans without in vivo studies;Regulatory Toxicology and Pharmacology;2024-09

2. Weight of Evidence: Is an Animal Study Warranted? Assessments for Carcinogenicity, Drug Abuse Liability, and Pediatric Safety;International Journal of Toxicology;2024-07-20

3. Exploring Greater Flexibility for Chronic Toxicity Study Designs to Support Human Safety Assessment While Balancing 3Rs Considerations;International Journal of Toxicology;2024-05-31

4. Why Pilot Studies?;A Guide to Sample Size for Animal‐based Studies;2023-09-15

5. CSL-Tox: an open-source analytical framework for the comparison of short-term and long-term toxicity end points and assessing the need of chronic studies in drug development;Scientific Reports;2023-09-08