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Comparison of the Pharmacokinetics, Safety, and Tolerability of the Autoinjector (AI) and Pre-Filled Syringe (PFS) of SB4 in Healthy Subjects
PURPOSE: SB4 is an etanercept biosimilar, approved by the European Commission (EC) and the US Food and Drug Administration (FDA) following a demonstration of equivalent efficacy and safety and comparable quality data to the reference product. This study aimed to demonstrate equivalent pharmacokineti...
Autores principales: | Shin, Donghoon, Kim, Younsoo, Go, Ahra, Velinova, Maria |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955637/ https://www.ncbi.nlm.nih.gov/pubmed/32021090 http://dx.doi.org/10.2147/DDDT.S224103 |
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