Successful Drug Development Despite Adverse Preclinical Findings Part 1: Processes to Address Issues and Most Important Findings-Reference-Cited by-同舟云学术

Successful Drug Development Despite Adverse Preclinical Findings Part 1: Processes to Address Issues and Most Important Findings

Published:2010 Issue:4 Volume:23 Page:189-211
ISSN:0914-9198
Container-title:Journal of Toxicologic Pathology
language:en
Short-container-title:J Toxicol Pathol

Author:

Ettlin Robert A.¹,Kuroda Junji²,Plassmann Stephanie³,Prentice David E.³

Affiliation:

1. Ettlin Consulting Ltd.

2. KISSEI Pharmaceutical Co., Ltd.

3. PreClinical Safety (PCS) Consultants Ltd.

Publisher

Japanese Society of Toxicologic Pathology

Subject

Toxicology,Pathology and Forensic Medicine

Link

https://www.jstage.jst.go.jp/article/tox/23/4/23_4_189/_pdf

Reference307 articles.

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3. 3. Yap YG and Camm AJ. Drug induced QT prolongation and torsades de pointes. Heart. 89: 1363-1372. 2003.

4. 4. International Conference on Harmonization (ICH). ICH harmonized tripartite guideline. Nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. S7B. 2005.

5. 5. De Bruin ML, Pettersson M, Meyboom RH, Hoes AW, and Leufkens HG. Anti-HERG activity and the risk of drug-induced arrhythmias and sudden death. Eur Heart J. 26: 590-597. 2005.

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