Successful Drug Development Despite Adverse Preclinical Findings Part 2: Examples-Reference-Cited by-同舟云学术

Successful Drug Development Despite Adverse Preclinical Findings Part 2: Examples

Published:2010 Issue:4 Volume:23 Page:213-234
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,Hayashi Makoto⁴,Prentice David E.³

Affiliation:

1. Ettlin Consulting Ltd.

2. KISSEI Pharmaceutical Co., Ltd.

3. PreClinical Safety (PCS) Consultants Ltd.

4. Biosafety Research Center, Foods, Drugs, and Pesticides (BSRC)

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_213/_pdf

Reference160 articles.

1. 1. Dorato MA and Engelhardt JA. The no-observed-adverse-effect-level in drug safety evaluations: Use, issues, and definition(s). Regul Toxicol Pharmacol. 42: 265-274. 2005.

2. 2. Cohen SM, Klaunig J, Meek ME, Hill RN, Pastoor T, Lehman-McKeeman L, Bucher J, Longfellow DG, Seed J, Dellarco V, Fenner-Crisp P, and Patton D. Evaluating the human relevance of chemically induced animal tumors. Toxicol Sci. 78: 181-186. 2004.

3. 3. Proceedings of the Eighteenth International Symposium of the Society of Toxicologic Pathologists, Washington DC, June 13-17, 1999. Toxicologic Pathology of the Nervous System. Toxicol Pathol. 28: 3-214. 2000.

4. 4. Kaufmann W. Cerebellar neurotoxins I. In: Classic Examples in Toxicologic Pathology, 3rd ed. E Karbe, W Drommer, PG Germann, G Morawietz, and R Kellner (eds). European Society of Toxicologic Pathology, Hannover. CD-ROM. 2009.

5. 5. Haworth R. Cerebellar neurotoxins II. In: Classic Examples in Toxicologic Pathology, 3rd ed. E Karbe, W Drommer, PG Germann, G Morawietz, and R Kellner (eds). European Society of Toxicologic Pathology, Hannover. CD-ROM. 2009.

Cited by 20 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. Current Assays in Endocrine Safety Pharmacology;Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays;2024

2. Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls;A Comprehensive Guide to Toxicology in Nonclinical Drug Development;2024

3. AMALPHI: A Machine Learning Platform for Predicting Drug-Induced PhospholIpidosis;Molecular Pharmaceutics;2023-12-22

4. Species Selection for Pharmaceutical Toxicity Studies;Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays;2023

5. Practical Considerations in Determining Adversity and the No-Observed-Adverse-Effect-Level (NOAEL) in Nonclinical Safety Studies: Challenges, Perspectives and Case Studies;International Journal of Toxicology;2022-03