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

Xavier Nicolas,Nassim Djebli,Clémence Rauch,Aurelie Brunet,Fabrice Hurbin,Jean-Marie Martinez,David Fabre

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

2019

Xavier Nicolas
Nassim Djebli
Clémence Rauch
Aurelie Brunet
Fabrice Hurbin
Jean-Marie Martinez
David Fabre

Background Alirocumab, a human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly lowers low-density lipoprotein cholesterol levels.

Keywords:

Kexin
Low-density lipoprotein
Alirocumab
PCSK9
Pharmacology
Cholesterol
Population
Lipoprotein
Proprotein convertase
Medicine
Pharmacodynamics
Statin
healthy volunteers
indirect response
Pharmacokinetics

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