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Population Pharmacokinetic/Pharmacodynamic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using an Indirect Response Model to Predict Low-Density Lipoprotein Cholesterol Lowering: Support for a Biologics License Application Submission: Part II

BACKGROUND: Alirocumab, a human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly lowers low-density lipoprotein cholesterol levels. OBJECTIVE: This analysis aimed to develop and qualify a population pharmacokinetic/pharmacodynamic model for alirocumab...

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Detalles Bibliográficos
Autores principales: Nicolas, Xavier, Djebli, Nassim, Rauch, Clémence, Brunet, Aurélie, Hurbin, Fabrice, Martinez, Jean-Marie, Fabre, David
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6325983/
https://www.ncbi.nlm.nih.gov/pubmed/29725997
http://dx.doi.org/10.1007/s40262-018-0670-5