Leveraging Clinical Pharmacology Data to Assess Biosimilarity and Interchangeability of Insulin Products

Vaidyanathan, J; Wang, YMC; Tran, D; Seo, SK

Vaidyanathan, J (通讯作者),US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 113 (4): 794

Abstract

There is over a hundred years of clinical experience with insulin for the treatment of diabetes. The US Food and Drug Administration (FDA) approved th......

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