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A Randomized, Single-dose, Phase I Clinical Comparison of a Trastuzumab Biosimilar With a Reference Trastuzumab Formulation in Healthy Chinese Male Volunteers.
Pu, Huahua; Jia, Jingying; Zhao, Chunyang; Hou, Sheng; Guo, Huaizu; Li, Jing; Qian, Weizhu; Wang, Hao; Sun, Chan; Zou, Yang.
Afiliación
  • Pu H; Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.
  • Jia J; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.
  • Zhao C; Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.
  • Hou S; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.
  • Guo H; Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.
  • Li J; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.
  • Qian W; Shanghai Zhangjiang Biotechnology Co., Ltd, Shanghai, China.
  • Wang H; Taizhou Mabtech Pharmaceuticals Co., Ltd, Jiangsu, China.
  • Sun C; Taizhou Mabtech Pharmaceuticals Co., Ltd, Jiangsu, China.
  • Zou Y; Taizhou Mabtech Pharmaceuticals Co., Ltd, Jiangsu, China.
Clin Pharmacol Drug Dev ; 12(2): 181-189, 2023 02.
Article en En | MEDLINE | ID: mdl-36317757

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Biosimilares Farmacéuticos Tipo de estudio: Clinical_trials Límite: Humans / Male Idioma: En Revista: Clin Pharmacol Drug Dev Año: 2023 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Biosimilares Farmacéuticos Tipo de estudio: Clinical_trials Límite: Humans / Male Idioma: En Revista: Clin Pharmacol Drug Dev Año: 2023 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos