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Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL‐1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus

AIMS: To report phase 1 bioequivalence results comparing MYL‐1501D, US reference insulin glargine (US IG), and European reference insulin glargine (EU IG). MATERIALS AND METHODS: The double‐blind, randomized, three‐way crossover study compared the pharmacokinetic (PK) and pharmacodynamic (PD) charac...

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Detalles Bibliográficos
Autores principales: Heise, Tim, Donnelly, Charles, Barve, Abhijit, Aubonnet, Patrick
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7079113/
https://www.ncbi.nlm.nih.gov/pubmed/31724253
http://dx.doi.org/10.1111/dom.13919