Successful Drug Development Despite Adverse Preclinical Findings Part 2: Examples

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

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.

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