Pharmacogenomics and Data Protection
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Bindu Dey
Abstract
Introduction
That the genes are responsible for disease susceptibility, differential drug response and drug toxicity was always suspected; post-genome developments, pharmacogenetics and pharmacogenomics have proven that beyond doubt. The trials of AstraZeneca drug, IRESSA, an EGFR kinase inhibitor approved for non-small lung cancer have clearly shown the consequences of exposing the non-responders to such drugs. It has also initiated an intense debate within the regulatory set up to seek genomic solutions to drug variability during development, clinical testing and their approvals. The strong drug lobby that is used to “one drug for all”, pushing their products across continents to re-coup the heavy ivestments made in R&D and currently fighting for “TRIPS plus” rights over ”Data Protection” may not like the population dynamics. However, one wonders the worth of such clinical data if the drug fails or induces adverse reactions in a different set of population with variation in crucial set of genes that the drug intends to target!
Walter de Gruyter GmbH & Co. KG
Artikel in diesem Heft
- Editorial
- Biosafety Regulation Trends in Southern and Southeastern Asia
- Property in a Human Body: A Common Law Approach
- Pharmacogenomics: An In-House Advantage?
- The German Way of Dealing with “The Tragedy of the Anticommons” – Purpose-Bound Protection for Product Patents on Genetic Information in Germany
- Pharmacogenomics and Data Protection
- Development and Implications of Patent Law
- Life Sciences and Biotechnology
- Declaration on Human Cloning
- Gene Therapy in PR China: Regulations and Ethical Concerns
- Biotechnological Potential of Marine Sponges and their Associated Bacteria as Producers of New Pharmaceuticals (Part I)
Artikel in diesem Heft
- Editorial
- Biosafety Regulation Trends in Southern and Southeastern Asia
- Property in a Human Body: A Common Law Approach
- Pharmacogenomics: An In-House Advantage?
- The German Way of Dealing with “The Tragedy of the Anticommons” – Purpose-Bound Protection for Product Patents on Genetic Information in Germany
- Pharmacogenomics and Data Protection
- Development and Implications of Patent Law
- Life Sciences and Biotechnology
- Declaration on Human Cloning
- Gene Therapy in PR China: Regulations and Ethical Concerns
- Biotechnological Potential of Marine Sponges and their Associated Bacteria as Producers of New Pharmaceuticals (Part I)
