Cited by 126Monoclonal and Polyclonal Antibodies ResearchBiosimilars and Bioanalytical MethodsImmunotoxicology and immune responses

Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development?

Deng, Rong, Jin, Feng, Prabhu, Saileta, Iyer, Suhasini·2012·Expert Opinion on Drug Metabolism & Toxicology

Abstract

INTRODUCTION: The number of monoclonal antibodies available for clinical use and under development has dramatically increased in the last 10 years. Understanding their pharmacokinetics and pharmacodynamics is essential for selecting the right clinical candidate, correct dose and regimen for a target indication. AREAS COVERED: This article reviews the existing literature and knowledge of monoclonal antibodies. Specifically, the authors discuss monoclonal antibodies with respect to their pharmacokinetics (including absorption, distribution and elimination) and their pharmacodynamics. The authors also look at the pharmacokinetic/pharmacodynamic relationship, scaling from preclinical to clinical studies and selection of the first-in-human dose. EXPERT OPINION: Monoclonal antibodies have complex pharmacokinetic and pharmacodynamic characteristics that are dependent on several factors. Therefore, it is important to improve our understanding of the pharmacokinetics and pharmacodynamics of monoclonal antibodies from a basic research standpoint. It is also equally important to apply mechanistic pharmacokinetic/pharmacodynamic models to interpret the experimental results and facilitate efforts to predict the safety and efficacy of monoclonal antibodies.

Integrity signals

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Crossref · 10.1517/17425255.2012.643868

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109 of 109 references verified0 citation errors · 0 not checkable

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  • Factors influencing mAbs distribution to individual organs or tissues include drug-specific features such as binding affinity to target antigens, target internalization rate, mAb hydrophilicity, and charge, and tissue-specific features such as membrane structure and blood flow.

    “Additional factors influencing mAbs distribution to individual organs or tissues include: drug‐specific features such as their binding affinity to specific target antigens, targets internalization rate,24 mAb hydrophilicity, charge,25 and tissue‐specific features such as membrane structure and blood flow.26”

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Authors
Deng, R., Jin, F., Prabhu, S., & Iyer, S.
Affiliations
  • Genentech (US)
  • Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
Venue
Expert Opinion on Drug Metabolism & Toxicology
Published
2012-01-17
Volume
8
Issue
2
Pages
141-160
ISSN
  • 1742-5255 (ISSN-L)
  • 1744-7607
OpenAlex
W1969671154
Cited by
126
References
109
Citations by year
2026: 4 · 2025: 5 · 2024: 5 · 2023: 7 · 2022: 8 · 2021: 7 · 2020: 6 · 2019: 10 · 2018: 11 · 2017: 13 · 2016: 9 · 2015: 19 · 2014: 6 · 2013: 13 · 2012: 3
FWCI
1.76
Type
journal article
Language
en
Open access
closed
Locations
  • Expert Opinion on Drug Metabolism & Toxicology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
  • Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotoxicology and immune responses
Keywords
monoclonal antibodies, pharmacokinetics, pharmacodynamics, pharmacokinetic-pharmacodynamic relationship, first-in-human dose selection, drug development
MeSH terms
Antibodies, Monoclonal, Humans, Drug Discovery

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