The AAPS Journal

, Volume 12, Issue 4, pp 592–601

Application of Quantitative Pharmacology in Development of Therapeutic Monoclonal Antibodies

Review Article Theme: Pharmacokinetic/Pharmadynamic Modeling and Simulation in Drug Discovery and Translational Research

DOI: 10.1208/s12248-010-9220-2

Cite this article as:
Tabrizi, M., Funelas, C. & Suria, H. AAPS J (2010) 12: 592. doi:10.1208/s12248-010-9220-2

Abstract

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.

KEY WORDS

monoclonal antibodiespharmacodynamics (PD)pharmacokinetics (PK)quantitative pharmacologytranslational strategies

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  • Mohammad Tabrizi
    • 1
  • Cherryl Funelas
    • 2
  • Hamza Suria
    • 3
  1. 1.Preclinical DevelopmentAnaptysBio, Inc.San DiegoUSA
  2. 2.Bioanalytical Development, Takeda San FranciscoSouth San FranciscoUSA
  3. 3.Corporate DevelopmentAnaptysBio, Inc.San DiegoUSA