This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Leighton, J. K. Search for Related Content PubMed PubMed Citation Articles by Leighton, J. K. Social Bookmarking                         What's this?

Application of Emerging Technologies in Toxicology and Safety Assessment: Regulatory Perspectives

Division of Oncology Drug Products, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland, USA

Correspondence: Address correspondence to John K. Leighton, PhD, DABT, Supervisory Pharmacologist, Division of Oncology Drug Products, FDA/CDER, 1451 Rockville Pike, Rockville, MD 20852, USA. E-mail:LEIGHTONJ{at}cder.fda.gov

Emerging technologies applied in the regulatory field encompass a group of technologies that are used in addition to or in replacement of the standard toxicology studies conducted to support an Investigational New Drug Application (IND) or New Drug Application (NDA). The standard package includes general toxicology studies of various duration, safety pharmacology studies, genetic toxicology studies, and reproductive toxicology studies. New and emerging technologies applied to the regulation of new drugs include the use of novel biomarkers, transfected cells and transgenic animals, and the "omics" technologies (toxicogenomics, proteomics, and metabonomics). These technologies are at various stages of regulatory development and acceptance. For example, the use of transgenic animals have gained acceptance by regulatory authorities to replace a 2-year carcinogenicity assay. Alternatively, the "omics" technologies are not sufficiently advanced to achieve regulatory acceptance as replacements, although these assays have a role early in drug development and they may prove useful as supplements to standard studies. Data from these assays have been used to address specific mechanistic questions in combination with standard toxicology assays.

Key Words: Biomarkers • Carcinogenicity Assessment • Critical Path • Toxicogenomics • Transgenic Animals

International Journal of Toxicology, Vol. 24, No. 3, 153-155 (2005)
DOI: 10.1080/10915810590948352


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				C. Friry-Santini, D. Rouquie, P. Kennel, H. Tinwell, M. Benahmed, and R. Bars Correlation between Protein Accumulation Profiles and Conventional Toxicological Findings Using a Model Antiandrogenic Compound, Flutamide Toxicol. Sci., May 1, 2007; 97(1): 81 - 93. [Abstract] [Full Text] [PDF]