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A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteers.
Zhou, Huan; Cao, Shugang; Zhu, Xingyu; Xie, Jing; Fan, Ling; Ge, Qin; Wang, Ying; Zhu, Juan; Liu, Yuanyuan; Shao, ZhongHuan; Shan, Rongfang; Liu, Bingyan; Wang, Hongju; Ding, Li.
Afiliação
  • Zhou H; Department of Pharmaceutical Analysis, School of Pharmacy, China Pharmaceutical University , Nanjing, Jiangsu, China.
  • Cao S; National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.
  • Zhu X; School of Pharmacy, Bengbu Medical University , Bengbu, Anhui, China.
  • Xie J; The Affiliated Hefei Hospital of Anhui Medical University , Hefei, Anhui, China.
  • Fan L; National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.
  • Ge Q; The Affiliated Hefei Hospital of Anhui Medical University , Hefei, Anhui, China.
  • Wang Y; School of Pharmacy, Bengbu Medical University , Bengbu, Anhui, China.
  • Zhu J; National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.
  • Liu Y; National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.
  • Shao Z; National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.
  • Shan R; National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.
  • Liu B; National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.
  • Wang H; National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.
  • Ding L; National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University , Bengbu, Anhui, China.
Expert Opin Drug Metab Toxicol ; 16(10): 997-1003, 2020 Oct.
Article em En | MEDLINE | ID: mdl-32847423
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares / Trastuzumab / Antineoplásicos Imunológicos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Humans / Male Idioma: En Revista: Expert Opin Drug Metab Toxicol Assunto da revista: METABOLISMO / TOXICOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: China País de publicação: Reino Unido
Texto completo
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XML
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares / Trastuzumab / Antineoplásicos Imunológicos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Humans / Male Idioma: En Revista: Expert Opin Drug Metab Toxicol Assunto da revista: METABOLISMO / TOXICOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: China País de publicação: Reino Unido