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

• Published in: Clinical pharmacokinetics Vol. 58; no. 1; pp. 101 - 113
• Main Authors: Martinez, Jean-Marie, Brunet, Aurélie, Hurbin, Fabrice, DiCioccio, A. Thomas, Rauch, Clémence, Fabre, David
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.01.2019; Springer Nature B.V
• Subjects: Adult; Aged; Antibodies, Monoclonal, Humanized - pharmacokinetics; Anticholesteremic Agents - pharmacokinetics; Biological Products - pharmacokinetics; Biological Variation, Individual; Cholesterol; Drug dosages; Female; Healthy Volunteers; Humans; Hypercholesterolemia - metabolism; Internal Medicine; Lipoproteins; Male; Medicine; Medicine & Public Health; Middle Aged; Models, Biological; Monoclonal antibodies; Multiple myeloma; Original; Original Research Article; Patients; Pharmacokinetics; Pharmacology/Toxicology; Pharmacotherapy; Statins; Studies

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 dev...