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Understanding Pharmacogenomics


Description: Pharmacogenomics is the branch of pharmacology, which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms (SNPs) with a drug's efficacy or toxicity. By doing so, pharmacogenomics aims to develop rational means to optimize drug therapy, with respect to the patients' genotype, to ensure maximum efficacy with minimal adverse effects. Such approaches promise the advent of "personalized medicine", in which drugs and drug combinations are optimized for each individual's unique genetic makeup.

Pharmacogenomics is the whole genome application of pharmacogenetics, which examines the single gene interactions with drugs.

The terms pharmacogenomics and pharmacogenetics tend to be used interchangeably, and a precise, consensus definition of either remains elusive. Pharmacogenetics is generally regarded as the study or clinical testing of genetic variation that gives rise to differing response to drugs, while pharmacogenomics is the broader application of genomic technologies to new drug discovery and further characterization of older drugs. Pharmacogenetics considers one or at most a few genes of interest, while pharmacogenomics considers the entire genome.

Much of current clinical interest is at the level of pharmacogenetics, involving variation in genes involved in, drug metabolism with a particular emphasis on improving drug safety. Many as an outstanding opportunity to improve prescribing safety and efficacy view the wider use of pharmacogenetic testing. Driving this trend are the 106,000 deaths and 2.2 million serious events caused by adverse drug reactions in the U.S. each year. As such ADRs are responsible for five to 7% of hospital admissions in the U.S. and Europe, lead to the withdrawal of 4% of new medicines and cost society an amount equal to the costs of drug treatment.

Comparisons of the list of drugs most commonly implicated in adverse drug reactions with the list of metabolizing enzymes with known polymorphisms found that drugs commonly involved in adverse drug reactions were also those that were metabolized by enzymes with known polymorphisms.

This report – Understanding Pharmacogenomics – looks at the basics of pharmacogenomics and analyzes how drug development and drug discovery processes are affected by pharmacogenomics. The report covers the economics of developing pharmacogenomics to aid drug development, the various impacts pharmacogenomics is to have on the healthcare industry in general, and much more. The report is a guide to the developing world of pharmacogenomics and how it is impacting every field of healthcare.


Contents: Executive Summary
Introduction to Pharmacogenomics
What is Pharmacogenomics?
Effect of Pharmacogenomics on Modern Day Medicine
Benefits of Pharmacogenomics
Economic Issues
Challenges Facing Pharmacogenomic Development
How Will Drug Development and Testing Benefit from Pharmacogenomics?
Biology of Pharmacogenetics and Pharmacogenomics
Pharmacogenomics, Pharmacogenetics and Drug Development
Pharmacogenetics and Healthcare
Pharmacogenetics and the Patient
Drug Characteristics, Drug Targets, and Side Effects of Pharmacogenomics
Introduction
Dealing with Drug Metabolism
Role of Drug Transporters
Pharmacogenomics and Molecular Diagnostic Processes for Development in Drug Therapy
Barriers and Challenges
Pharmacogenomics in Drug Development Processes and Ethical Viewpoints
Introduction
Basics of Clinical Trial Design .
Pharmacogenomic Profiling in Clinical Trials
Scientific Barriers Facing Pharmacogenomic Trials
Classification of Human Research Subjects
Commercial Interests and Economics
Looking at New Social Issues and Risks

What the Future Holds
Pharmacogenetics and Regulatory Issues
Analyzing the Economics of Pharmacogenomics
Introduction
Potential Framework for Assessing the Cost Effectiveness of Pharmacogenomics
Pharmacodynamic-based Approach
Cardiovascular Disease
Infectious Disease
Pharmacokinetic-based Approach
Warfarin
Conclusion

Appendix

Glossary




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