Application of Quantitative Pharmacology in Development of Therapeutic Monoclonal Antibodies

被引：18

作者：

Tabrizi, Mohammad ^{[1
]}

Funelas, Cherryl ^{[2
]}

Suria, Hamza ^{[3
]}

机构：

[1] AnaptysBio Inc, Preclin Dev, San Diego, CA 92121 USA

[2] Takeda San Francisco, Bioanalyt Dev, San Francisco, CA USA

[3] AnaptysBio Inc, Corp Dev, San Diego, CA 92121 USA

来源：

AAPS JOURNAL | 2010年 / 12卷 / 04期

关键词：

monoclonal antibodies; pharmacodynamics (PD); pharmacokinetics (PK); quantitative pharmacology; translational strategies; DEPENDENT CELLULAR CYTOTOXICITY; ENDOTHELIAL GROWTH-FACTOR; KAPPA-B LIGAND; POPULATION PHARMACOKINETICS; PHASE-I; RECEPTOR ACTIVATOR; MULTIPLE-MYELOMA; BONE METASTASES; CANCER-PATIENTS; HIGH-AFFINITY;

D O I：

10.1208/s12248-010-9220-2

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The advancement of therapeutic monoclonal antibodies during various stages of the drug development process can be effectively streamlined when appropriate translational strategies are applied. Design of successful translational strategies for development of monoclonal antibodies should allow for understanding of the dose- and concentration-response relationships with respect to both beneficial and toxic effects from early phases of drug development. Evaluation of relevant biomarkers during early stages of drug development should facilitate the successful design of safe and effective dosing strategies. Moreover, application of quantitative pharmacology is critical for translation of exposure-response relationships early on.

引用

页码：592 / 601

页数：10

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