Population Pharmacokinetic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using a Michaelis–Menten Approximation of a Target-Mediated Drug Disposition Model—Support for a Biologics License Application Submission: Part I

BACKGROUND: Alirocumab, a human monoclonal antibody, inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) to significantly reduce low-density lipoprotein cholesterol levels; pharmacokinetics (PK) are governed by non-linear, target-mediated drug disposition (TMDD). OBJECTIVES: We aimed to d...

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Detalles Bibliográficos
Autores principales: Martinez, Jean-Marie, Brunet, Aurélie, Hurbin, Fabrice, DiCioccio, A. Thomas, Rauch, Clémence, Fabre, David
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2018
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6325993/
https://www.ncbi.nlm.nih.gov/pubmed/29725996
http://dx.doi.org/10.1007/s40262-018-0669-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6325993/
https://www.ncbi.nlm.nih.gov/pubmed/29725996
http://dx.doi.org/10.1007/s40262-018-0669-y

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