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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...

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Detalles Bibliográficos
Autores principales: Shin, Donghoon, Kim, Younsoo, Go, Ahra, Velinova, Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2020
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