Nonclinical safety testing of biopharmaceuticals – Addressing current challenges of these novel and emerging therapies-Reference-Cited by-同舟云学术

Nonclinical safety testing of biopharmaceuticals – Addressing current challenges of these novel and emerging therapies

Published:2015-10 Issue:1 Volume:73 Page:265-275
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Brennan Frank R.,Baumann Andreas,Blaich Guenter,de Haan Lolke,Fagg Rajni,Kiessling Andrea,Kronenberg Sven,Locher Mathias,Milton Mark,Tibbitts Jay,Ulrich Peter,Weir Lucinda^ORCID

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference32 articles.

1. Therapeutic window of MuS110, a single-chain antibody construct bispecific for murine EpCAM and murine CD3;Amann;Cancer Res.,2008

2. New challenges and opportunities in nonclinical safety testing of biologics;Baumann;Reg. Toxicol. Pharmacol.,2014

3. Immtac-redirected tumour cell killing induces and potentiates antigen cross-presentation by dendritic cells;Bossi;Cancer Immunol. Immunother.,2014

4. Monoclonal antibody-induced cytokine-release syndrome;Bugelski;Expert Rev. Clin. Immunol.,2009

5. Development of the immune system in the cynomolgus monkey: the appropriate model in human targeted toxicology?;Buse;J. Immunotoxicol.,2005

Cited by 13 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. Clinical Design and Analysis Strategies for the Development of Gene Therapies: Considerations for Quantitative Drug Development in the Age of Genetic Medicine;Clinical Pharmacology & Therapeutics;2021-03-24

2. Nonclinical Development of Biologics: Integrating Safety, Pharmacokinetics, and Pharmacodynamics to Create Smarter and More Flexible Nonclinical Safety Programs Optimizing Animal Use;International Journal of Toxicology;2021-02-25

3. Challenges of non-clinical safety testing for biologics: A Report of the 9th BioSafe European Annual General Membership Meeting;mAbs;2021-01-01

4. Animal Safety, Toxicology, and Pharmacokinetic Studies According to the ICH S9 Guideline for a Novel Fusion Protein tTF-NGR Targeting Procoagulatory Activity into Tumor Vasculature: Are Results Predictive for Humans?;Cancers;2020-11-26

5. 4-Week toxicity study of biosimilar natalizumab in comparison to Tysabri® by repeated intravenous infusion to cynomolgus monkeys;Drug and Chemical Toxicology;2020-02-06