A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin (R)) in healthy Chinese male volunteers-MedSci.cn

A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin (R)) in healthy Chinese male volunteers

Zhou, H; Cao, SG; Zhu, XY; Xie, J; Fan, L; Ge, Q; Wang, Y; Zhu, J; Liu, YY; Shao, ZH; Shan, RF; Liu, BY; Wang, HJ; Ding, L

Ding, L (corresponding author), China Pharmaceut Univ, Sch Pharm, Dept Pharmaceut Anal, Nanjing 211198, Jiangsu, Peoples R China.; Wang, HJ (corresponding author), Bengbu Med Univ, Affiliated Hosp 1, Natl Inst Clin Drug Trials, Bengbu 233000, Anhui, Peoples R China.

Abstract

Objectives This study aimed to evaluate the bioequivalence, safety, tolerability and immunogenicity of the biosimilar trastuzumab (SIBP-01) compared t......

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A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin (R)) in healthy Chinese male volunteers

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