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
收藏
页码:592 / 601
页数:10
相关论文
共 50 条
  • [1] Application of Quantitative Pharmacology in Development of Therapeutic Monoclonal Antibodies
    Mohammad Tabrizi
    Cherryl Funelas
    Hamza Suria
    The AAPS Journal, 2010, 12 : 592 - 601
  • [2] Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework
    Jason H. Williams
    Kai H. Liao
    Donghua Yin
    Xu Meng
    The AAPS Journal, 26
  • [3] Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework
    Williams, Jason H.
    Liao, Kai H.
    Yin, Donghua
    Meng, Xu
    AAPS JOURNAL, 2024, 26 (02):
  • [4] The clinical pharmacology of therapeutic monoclonal antibodies
    Roskos, LK
    Davis, CG
    Schwab, GM
    DRUG DEVELOPMENT RESEARCH, 2004, 61 (03) : 108 - 120
  • [5] The pharmacology and therapeutic applications of monoclonal antibodies
    Castelli, Maria Sofia
    McGonigle, Paul
    Hornby, Pamela J.
    PHARMACOLOGY RESEARCH & PERSPECTIVES, 2019, 7 (06): : e00535
  • [6] Pharmacology and safety assessment of humanized monoclonal antibodies for therapeutic use
    Klingbeil, C
    Hsu, DH
    TOXICOLOGIC PATHOLOGY, 1999, 27 (01) : 1 - 3
  • [7] Considerations for the development of therapeutic monoclonal antibodies
    Swann, Patrick G.
    Tolnay, Mate
    Muthukkumar, Subramanian
    Shapiro, Marjorie A.
    Rellahan, Barbara L.
    Clouse, Kathleen A.
    CURRENT OPINION IN IMMUNOLOGY, 2008, 20 (04) : 493 - 499
  • [8] Therapeutic Monoclonal Antibodies in Treatment and Development
    Farsa, Oldrich
    CHEMICKE LISTY, 2013, 107 (06): : 464 - 470
  • [9] Drug Development of Therapeutic Monoclonal Antibodies
    Mould, Diane R.
    Meibohm, Bernd
    BIODRUGS, 2016, 30 (04) : 275 - 293
  • [10] Drug Development of Therapeutic Monoclonal Antibodies
    Diane R. Mould
    Bernd Meibohm
    BioDrugs, 2016, 30 : 275 - 293