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Current Issue:
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"
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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 |
|