Fixed Versus Body-Sized-Based Dosing of Monoclonal Antibodies

Brian L. Erstad, Lisa E. Davis

Research output: Contribution to journalComment/debatepeer-review

Abstract

Monoclonal antibody products are an increasing portion of novel drug approvals. The labeling of initial drug approvals frequently involves body-size-based rather than fixed-dose administration regimens for adults without clear rationale for doing so. This presents challenges when prescribing these products for patients with extremes of body habitus who constitute a small portion of enrollment in pre-approval investigations. Fixed-dose regimens allow for standardized preparation with the potential to reduce the risk of calculation errors, drug waste, and make home administration more practical. Fixed-dose rather than body-size-based monoclonal antibody regimens should serve as the initial approach in early phase 1 clinical trials.

Original languageEnglish (US)
Pages (from-to)91-95
Number of pages5
JournalAnnals of Pharmacotherapy
Volume58
Issue number1
DOIs
StatePublished - Jan 2024

Keywords

  • drug approval
  • drug dosing
  • monoclonal antibodies
  • pharmacokinetics
  • subcutaneous injection
  • weight

ASJC Scopus subject areas

  • Pharmacology (medical)

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