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Dose Determinations at Drug Approval Reviews: FDA-Approved Drugs in Past 5 Years

Sachiko Mita1, Shunsuke Ono1

  • 1Laboratory of Pharmaceutical Regulatory Science, Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, Japan.

Clinical Pharmacology and Therapeutics
|February 25, 2025
PubMed
Summary

Drug dose adjustments are common during Food and Drug Administration (FDA) reviews. Factors like accelerated approval and safety data influence dose modifications for new molecular entities (NMEs).

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