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ToxSci Advance Access originally published online on December 28, 2006
Toxicological Sciences 2007 96(1):16-20; doi:10.1093/toxsci/kfl191
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Published by Oxford University Press 2006.

Genetic Toxicity Assessment: Employing the Best Science for Human Safety Evaluation Part I: Early Screening for Potential Human Mutagens

David Jacobson-Kram*,1 and Joseph F. Contrera{dagger}

* Office of New Drugs {dagger} Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993

1 To whom correspondence should be addressed at the Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Fax: (301) 796-9856. E-mail: david.jacobsonkram{at}fda.hhs.gov.

Received September 18, 2006; accepted November 28, 2006


  Abstract

Results of genetic toxicology tests are used by FDA's Center for Drug Evaluation and Research as a surrogate for carcinogenicity data during the drug development process. Mammalian in vitro assays have a high frequency of positive results which can impede or derail the drug development process. To reduce the risk of such delays, most pharmaceutical companies conduct early non-GLP (good laboratory practices) studies to eliminate drug candidate with mutagenic or clastogenic activity. Early screens include in silico structure activity assessments and various iterations of the ultimate regulatory mandated GLP studies.

Key Words: mutagenesis; clastogenesis; structure activity; bacterial mutation.


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[Abstract] [Full Text] [PDF]


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