Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals
Author:
Publisher
Elsevier BV
Subject
Toxicology,General Medicine
Reference39 articles.
1. Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics;Agoram;Br. J. Clin. Pharmacol.,2009
2. Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics;Boxenbaum;J. Pharmacokinet. Biopharm.,1982
3. Pharmacokinetics and pharmacodynamics of protein therapeutics;Braeckman,2000
4. Alternative strategies for toxicity testing of species-specific biopharmaceuticals;Bussiere;Int. J. Toxicol.,2009
5. Preclinical safety evaluation of biotechnology-derived pharmaceuticals;Cavagnaro;Nat. Rev. Drug Discov.,2002
Cited by 40 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. Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno‐Safety Technical Committee (ITC);Clinical Pharmacology & Therapeutics;2024-06-07
2. Estimation of human absorbed radiation dose of radiopharmaceuticals based on animal biodistribution data: A review from last decade;AIP Conference Proceedings;2024
3. Preclinical Development of Monoclonal Antibodies;A Comprehensive Guide to Toxicology in Nonclinical Drug Development;2024
4. Utilizing PK and PD Biomarkers to Guide the First-in-Human Starting Dose Selection of MTBT1466A: A Novel Humanized Monoclonal Anti-TGFβ3 Antibody for the Treatment of Fibrotic Diseases;Journal of Pharmaceutical Sciences;2023-11
5. Strategies for overcoming the biological barriers associated with the administration of inhaled monoclonal antibodies for lung diseases;Expert Opinion on Drug Delivery;2023-08-03
1.学者识别学者识别
2.学术分析学术分析
3.人才评估人才评估
"同舟云学术"是以全球学者为主线，采集、加工和组织学术论文而形成的新型学术文献查询和分析系统，可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容，当前同舟云学术共收录了国内外主流学术期刊6万余种，收集的期刊论文及会议论文总量共计约1.5亿篇，并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询！咨询电话：010-8811{复制后删除}0370
www.globalauthorid.com
TOP
Copyright © 2019-2024 北京同舟云网络信息技术有限公司 京公网安备11010802033243号 京ICP备18003416号-3