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Similar Pharmacokinetics of the Adalimumab (Humira(®)) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE(®)-AI and VOLTAIRE(®)-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials
INTRODUCTION: BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira(®). We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS). METHODS:...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6251849/ https://www.ncbi.nlm.nih.gov/pubmed/29959660 http://dx.doi.org/10.1007/s40744-018-0119-1 |