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Evaluation of Truncated AUC as an Alternative Measure to Assess Pharmacokinetic Comparability in Bridging Biologic-Device Using Prefilled Syringes and Autoinjectors

Wen, YF; Ji, P; Schrieber, SJ; Rathi, S; Mcguirt, D; Liu, J; Chen, JM; Wang, YM; Doddapaneni, S; Sahajwalla, C

Ji, P (通讯作者),US FDA, Div Inflammat & Immune Pharmacol, Off Clin Pharmacol, Off Translat Sci,Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.

JOURNAL OF CLINICAL PHARMACOLOGY, 2023; 63 (12): 1417

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