A <scp>case‐study</scp> of <scp>model‐informed</scp> drug development of a novel <scp>PCSK9</scp> anti sense oligonucleotide. Part 1: First time in man to phase II-Reference-Cited by-同舟云学术

A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1: First time in man to phase II

Published:2022-10 Issue:12 Volume:11 Page:1569-1577
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacom & Syst Pharma

Author:

Knöchel Jane¹^ORCID,Nilsson Catarina¹,Carlsson Björn²,Wernevik Linda²,Hofherr Alexis²,Gennemark Peter³,Jansson‐Löfmark Rasmus³,Isaksson Rikard⁴,Rydén‐Bergsten Tina²,Hamrén Bengt¹,Rekić Dinko¹^ORCID

Affiliation:

1. Clinical Pharmacology and Quantitative Pharmacology Clinical Pharmacology and Safety Sciences, AstraZeneca AB R&D Gothenburg Gothenburg Sweden

2. Research and Early Development, Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca Gothenburg Sweden

3. DMPK, Research and Early Development Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca Gothenburg Sweden

4. Early Biometrics and Statistical Innovation BioPharmaceuticals R&D, AstraZeneca Gothenburg Sweden

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12866

Reference23 articles.

1. An oral antisense oligonucleotide for PCSK9 inhibition

2. ETESIAN: A PHASE 2B STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF AZD8233, A PCSK9-TARGETED ANTISENSE OLIGONUCLEOTIDE, IN PATIENTS WITH DYSLIPIDEMIA

3. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease

4. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome

5. Rosuvastatin Demonstrates Greater Reduction of Low-Density Lipoprotein Cholesterol Compared with Pravastatin and Simvastatin in Hypercholesterolaemic Patients: A Randomized, Double-Blind Study

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. From Plan to Pivot: How Model‐Informed Drug Development Shaped the Dose Strategy of the Zibotentan/Dapagliflozin ZENITH Trials;Clinical Pharmacology & Therapeutics;2024-07-03

2. Population pharmacokinetics of a novel PCSK9 antisense oligonucleotide;British Journal of Clinical Pharmacology;2024-03-19

3. The US Food and Drug Administration's Model‐Informed Drug Development Meeting Program: From Pilot to Pathway;Clinical Pharmacology & Therapeutics;2024-03-06

4. Novel and Emerging LDL-C Lowering Strategies: A New Era of Dyslipidemia Management;Journal of Clinical Medicine;2024-02-22