Clinical Pharmacology Studies Supporting Oligonucleotide Therapy Development: An Assessment of Therapies Approved and in Development Between 2012 and 2018-Reference-Cited by-同舟云学术

Clinical Pharmacology Studies Supporting Oligonucleotide Therapy Development: An Assessment of Therapies Approved and in Development Between 2012 and 2018

Published:2021-01-27 Issue:2 Volume:14 Page:468-475
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clin Transl Sci

Author:

Rogers Hobart¹,Adeniyi Oluseyi¹,Ramamoorthy Anuradha¹,Bailey Samantha²,Pacanowski Michael¹

Affiliation:

1. Center for Drug Evaluation and Research Office of Translational Sciences Office of Clinical Pharmacology US Food and Drug Administration Silver Spring Maryland USA

2. School of Pharmacy University of Pittsburgh Pittsburgh Pennsylvania USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12945

Reference24 articles.

1. Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity

2. As Technologies for Nucleotide Therapeutics Mature, Products Emerge

3. FDA-Approved Oligonucleotide Therapies in 2017

4. Chemistry, mechanism and clinical status of antisense oligonucleotides and duplex RNAs

5. Pharmacokinetics, biodistribution and cell uptake of antisense oligonucleotides

Cited by 12 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. Population pharmacokinetics of imetelstat, a first‐in‐class oligonucleotide telomerase inhibitor;CPT: Pharmacometrics & Systems Pharmacology;2024-05-21

2. Scientific Review of the Proarrhythmic Risks of Oligonucleotide Therapeutics: Are Dedicated ICH S7B/E14 Studies Needed for Low‐Risk Modalities?;Clinical Pharmacology & Therapeutics;2024-02-16

3. Overview of the Nonclinical Development Strategies and Class Effects of Oligonucleotide-based Therapeutics;A Comprehensive Guide to Toxicology in Nonclinical Drug Development;2024

4. Predicting the pharmacokinetics and pharmacodynamics of antisense oligonucleotides: an overview of various approaches and opportunities for PBPK/PD modelling;Expert Opinion on Drug Metabolism & Toxicology;2023-11-18