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April 2009, Volume 8, Issue 1: "FDA Bioinformatics Tool for Public Use-ArrayTrack"

PDF Version, Past Issues

The formation of the Human Genome Project in 1990 to complete the entire DNA sequence of ourselves initiated an era of unprecedented growth in knowledge of human biology and opened the door to the future of medicine that we see unfolding today. The general scientific discipline descending from the genome project is commonly called “genomics,” followed by the science for analysis of protein patterns resulting from the gene product (or “proteomics”) and then the measurement of the flux of these proteins during metabolism (“metabolomics or metabonomics”) have developed. Through these high-throughput technologies, science is prepared to define the threads between the observations of scientific investigations and the observations of nearly 2500 years of medicine that began with the great Greek physician, Hippocrates (ca. 460-367 BC).

Ethical, legal, and social issues attendant to the genome project are often a leading manifestation of this accomplishment to the general public along with terms such as “gene therapy” and “personalized medicine” coming into everyday usage. Parallel to known public accomplishments and arising ethical issues leading from the genome project came nearly silent but equally astounding leaps in technological innovation supporting these sciences, and an ever burgeoning level of information produced from these technologies, nearly unimaginable only a few years before, had to be stored and analyzed. From this basic need, and the need for the Food and Drug Administration to evaluate the results and impact of these technologies upon the health and safety of drugs, biologics, foods and medical in a predicable and efficient manner, came the development of ArrayTrack™. ArrayTrack™ is a publically available tool that provides a uniform storage facility for the vast amounts of genomic, proteomic, and metabolomics data accumulated in clinical and preclinical studies; a library assembly for all related data in public repositories, chemical characterization, and data analysis tools for establishing relationships and predictions to the repository of human physiologic knowledge. Outgrowths of this project have also included enterprises to establish uniform standards for the accumulation, storage, and possible interpretations of data arising during the post-genome era.

The objective of the Regulatory Research Perspectives journal is to provide a vehicle for FDA scientists to communicate important scientific information to each other with the hope of generating collaborations and to communicate to the global community science that is important to the Agency. It is hoped that each center will submit manuscripts for publication through their respective editorial board members. See the "Instructions to Authors" provided on this site.

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Past Issues

Date Title Text
Version
PDF
Version
July 2007 Studies on the Influence of Dietary Isoflavones, Daidzein and Genistein, in Chemical Mutagenesis and Tumor Development in Female Rats text version pdf version
March 2006 Technical Issues Involved in Obtaining Reliable Data from Microarray Experiments text version pdf version
March 2005 Application of a Systems Biology/Systems Toxicology Approach to Developmental Neurotoxicology text version pdf version
April 2004 Influence of Body Weight, Diet, and Stress on Aging, Survival and Pathological Endpoints in Rodents: Implications for Toxicity Testing and Risk Assessment text version pdf version
January 2003 On the Chemical Causation of Methyl Deficiency and its Attendant Pathologies text version pdf version
May 2002 Development of Quantitative Structure-Activity Relationships (QSARs) and Their Use for Priority Setting in the Testing Strategy of Endocrine Disruptors text version pdf version
November 2001 Developing Methods of Genetic Analysis to Improve Cancer Risk Assessment text version pdf version
July 2001 Human Health Impact and Regulatory Issues Involving Antimicrobial Resistance in the Food Animal Production Environment text version pdf version

 

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