Combined Semi-mechanistic Target-Mediated Drug Disposition and Pharmacokinetic–Pharmacodynamic Models of Alirocumab, PCSK9, and Low-Density Lipoprotein Cholesterol in a Pooled Analysis of Randomized Phase I/II/III Studies

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

(2018) Xavier Nicolas et al.   CLINICAL PHARMACOKINETICS

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

(2018) Jean-Marie Martinez et al.   CLINICAL PHARMACOKINETICS

Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome

(2018) Gregory G. Schwartz et al.   NEW ENGLAND JOURNAL OF MEDICINE

Combined proportional and additive residual error models in population pharmacokinetic modelling

(2017) Johannes H. Proost   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Impact of Target-Mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

(2016) John P. Gibbs et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events

(2015) Jennifer G. Robinson et al.   NEW ENGLAND JOURNAL OF MEDICINE

A Randomized Study of the Relative Pharmacokinetics, Pharmacodynamics, and Safety of Alirocumab, a Fully Human Monoclonal Antibody to PCSK9, After Single Subcutaneous Administration at Three Different Injection Sites in Healthy Subjects

(2014) Catherine Lunven et al.   Cardiovascular Therapeutics

PCSK9 and lipid lowering drugs

(2014) Yuan-Lin Guo et al.   CLINICA CHIMICA ACTA

Monotherapy with the PCSK9 inhibitor alirocumab versus ezetimibe in patients with hypercholesterolemia: Results of a 24week, double-blind, randomized Phase 3 trial

(2014) Eli M. Roth et al.   INTERNATIONAL JOURNAL OF CARDIOLOGY

The PCSK9 decade

(2012) Gilles Lambert et al.   JOURNAL OF LIPID RESEARCH

Population Pharmacokinetics of Therapeutic Monoclonal Antibodies

(2010) Nathanael L. Dirks et al.   CLINICAL PHARMACOKINETICS

Target-mediated drug disposition model: approximations, identifiability of model parameters and applications to the population pharmacokinetic–pharmacodynamic modeling of biologics

(2009) Leonid Gibiansky et al.   Expert Opinion on Drug Metabolism & Toxicology