Quantitative pharmacology approach to select optimal dose and study the important factors in determining disposition of therapeutic monoclonal antibody in pediatric subjects - some considerations

Deni Hardiansyah, Chee M. Ng

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

1 Citation (Scopus)

Abstract

Dose selection of monoclonal antibodies (mAb) in pediatric subjects is often based on the assumption that disease and pharmacodynamics in children are similar to those in adult, and only prior information of pharmacokinetic (PK) data in adults is used for dose selection. The PK of the mAbs is affected by the body size, and other patient-specific factors such as age, target-antigen levels, and disease activity. Among these factors, size-related changes have been well studied and frequently identified as the most clinically relevant covariate to affect PK of mAbs in the absence of the target-mediated drug disposition. Physiologically based pharmacokinetic (PBPK) modeling has been proven as a powerful method to analyze the disposition of small molecule drugs and mAbs. This chapter describes how to use minimum PBPK model to investigate the effects of Fc receptor developmental pharmacology on the PK of mAbs in pediatric subjects.

Original languageEnglish
Title of host publicationQuantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases
PublisherWiley-Blackwell
Pages285-314
Number of pages30
ISBN (Electronic)9781119289234
ISBN (Print)9781119289197
DOIs
Publication statusPublished - 1 Jan 2019

Keywords

  • Dose selection
  • Fc receptor developmental pharmacology
  • Pediatric dose
  • Pharmacodynamics
  • Physiologically based pharmacokinetic modeling
  • Quantitative pharmacology approach
  • Therapeutic monoclonal antibody

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