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 language | English (US) |
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Pages (from-to) | 91-95 |
Number of pages | 5 |
Journal | Annals of Pharmacotherapy |
Volume | 58 |
Issue number | 1 |
DOIs |
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State | Published - Jan 2024 |
Keywords
- drug approval
- drug dosing
- monoclonal antibodies
- pharmacokinetics
- subcutaneous injection
- weight
ASJC Scopus subject areas
- Pharmacology (medical)