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Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects.
Wynne, Christopher; Altendorfer, Mario; Sonderegger, Ivo; Gheyle, Lien; Ellis-Pegler, Rod; Buschke, Susanne; Lang, Benjamin; Assudani, Deepak; Athalye, Sandeep; Czeloth, Niklas.
Afiliação
  • Wynne C; a Christchurch Clinical Studies Trust , Christchurch , New Zealand.
  • Altendorfer M; b Boehringer Ingelheim , Ingelheim , Germany.
  • Sonderegger I; b Boehringer Ingelheim , Ingelheim , Germany.
  • Gheyle L; c SGS, Clinical Pharmacology Unit , Antwerp , Belgium.
  • Ellis-Pegler R; d Auckland Clinical Studies Limited , Auckland , New Zealand.
  • Buschke S; b Boehringer Ingelheim , Ingelheim , Germany.
  • Lang B; b Boehringer Ingelheim , Ingelheim , Germany.
  • Assudani D; b Boehringer Ingelheim , Ingelheim , Germany.
  • Athalye S; b Boehringer Ingelheim , Ingelheim , Germany.
  • Czeloth N; b Boehringer Ingelheim , Ingelheim , Germany.
Expert Opin Investig Drugs ; 25(12): 1361-1370, 2016 Dec.
Article em En | MEDLINE | ID: mdl-27813422
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antirreumáticos / Medicamentos Biossimilares / Adalimumab Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Humans / Male Idioma: En Ano de publicação: 2016 Tipo de documento: Article
Buscar no Google
Imprimir
XML
PubMed Links

Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antirreumáticos / Medicamentos Biossimilares / Adalimumab Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Humans / Male Idioma: En Ano de publicação: 2016 Tipo de documento: Article