Projecting human pharmacokinetics of monoclonal antibodies from nonclinical data: comparative evaluation of prediction approaches in early drug development

被引：51

作者：

Wang, Jing ^{[1
,2
]}

Iyer, Suhasini ^{[3
,4
]}

Fielder, Paul J. ^{[3
]}

Davis, John D. ^{[3
,5
]}

Deng, Rong ^{[3
]}

机构：

[1] Global DMPK, Takeda Calif, San Diego, CA USA

[2] Tesaro Inc, Waltham, MA USA

[3] Genentech Inc, Genentech Res & Early Dev, San Francisco, CA 94080 USA

[4] AbbVie Biotherapeut, Redwood City, CA USA

[5] Regeneron Pharmaceut Inc, Tarrytown, NY USA

来源：

BIOPHARMACEUTICS & DRUG DISPOSITION | 2016年 / 37卷 / 02期

关键词：

monoclonal antibody; pharmacokinetics; allometry scaling; target-mediated drug disposition; species-invariant time method; NEONATAL FC-RECEPTOR; PBPK MODEL; PRECLINICAL PHARMACOKINETICS; THERAPEUTIC ANTIBODIES; BINDING-AFFINITY; HUMAN IGG1; SUBCUTANEOUS BIOAVAILABILITY; TISSUE DISTRIBUTION; CYNOMOLGUS MONKEYS; DISPOSITION MODEL;

D O I：

10.1002/bdd.1952

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Currently, more than 350 monoclonal antibodies (mAbs) and mAb derivatives are under development as therapeutics. The prediction of mAb pharmacokinetics (PK)/pharmacodynamics (PD) plays a key role in starting dose selection for first-in-human (FIH) studies. This article presents a brief overview of the biology and mechanisms of absorption, distribution, metabolism and excretion (ADME) for mAbs. In addition, a detailed review of mAb human PK/PD prediction from nonclinical data is provided, including allometry for mAbs with linear or nonlinear PK, species-invariant time method, physiologically based PK (PBPK) modeling and target-mediated drug disposition (TMDD) model, bioavailability projection and immunogenicity impact on PK prediction. Finally, from an industry perspective a decision tree of mAb human PK projection is proposed to facilitate drug development. Copyright (c) 2015 John Wiley & Sons, Ltd.

引用

页码：51 / 65

页数：15

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