Tutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development

被引：187
作者：
Ovacik, Meric [1 ]
Lin, Kedan [2 ]
机构：
[1] Genentech Inc, Dept Preclin & Translat Pharmacokinet, San Francisco, CA 94080 USA
[2] NGM Biopharmaceut Inc, Clin Pharmacol, San Francisco, CA 94080 USA
来源：
CTS-CLINICAL AND TRANSLATIONAL SCIENCE | 2018年 / 11卷 / 06期
关键词：
NEONATAL FC-RECEPTOR; PROJECTING HUMAN PHARMACOKINETICS; SUBTILISIN/KEXIN TYPE 9; THERAPEUTIC ANTIBODIES; BISPECIFIC ANTIBODIES; PRECLINICAL PHARMACOKINETICS; DRUG DEVELOPMENT; POPULATION PHARMACOKINETICS; CLINICAL-PHARMACOLOGY; TISSUE DISTRIBUTION;
D O I：
10.1111/cts.12567
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in the context of drug development. Topics covered include an overview of antibody development, PK characteristics, and the application of antibody PK/pharmacodynamics (PD) in research and development decision-making. We also discuss the general considerations for planning a nonclinical PK program and describe the types of PK studies that should be performed during early development of monoclonal antibodies.
引用
收藏
页码：540 / 552
页数：13
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