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Modeling Clinical Development Strategies with Biomarkers at the FDA
A recently concluded cooperative R&D project at the FDA led to the development of a web-enabled software tool that will be useful for modeling the impact of predictive biomarkers on the complexity and cost of clinical development programs. Hear from the project's FDA Principal Investigator and from Adaptive Pharmacogenomic's PI on the project in a pair of webinars, August 24 and 25.
Membrane transporters and drug development: relevance to pharmacogenomics, nutrigenomics, epigenetics, and systems biology.
Methods Mol Biol. 2010;637:1-21
Authors: Yan Q
The study of membrane transporters may result in breakthroughs in the discovery of new drugs and the development of safer drugs. Membrane transporters are essential for fundamental cellular functions and normal physiological processes. These molecules influence drug absorption and distribution and play key roles in drug therapeutic effects.
Bioinformatics for transporter pharmacogenomics and systems biology: data integration and modeling with UML.
Methods Mol Biol. 2010;637:23-45
Authors: Yan Q
Bioinformatics is the rational study at an abstract level that can influence the way we understand biomedical facts and the way we apply the biomedical knowledge.
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Press covers FDA/industry biomarker plans
Nature Reviews Drug Discovery's (NRDD) Bethan Hughes reports on a joint FDA/industry effort to develop a common perspective on stratified medicine.
As reported in the NRDD article, the FDA's experiences with Voluntary Exploratory Data Submissions (VXDS) raised awareness at the agency that the complexity and cost of clinical development with biomarkers was a concern for industry. Reaching outside the Beltway to industry and academia, the FDA hosted a workshop at its White Oak, Maryland campus on October 21 and 22, 2009. Adaptive Pharmacogenomics's Michael Palmer organized and chaired the White Oak workshop.
Pharmacogenetics of cytochrome P450 (CYP) in the elderly.
Pharmacogenetics of cytochrome P450 (CYP) in the elderly.
Ageing Res Rev. 2010 Jun 20;
Authors: Seripa D, Pilotto A, Panza F, Matera MG, Pilotto A
The genetics of cytochrome P450 (CYP) is a very active area of multidisciplinary research, overlapping the interest of medicine, biology and pharmacology, being the CYP enzyme system responsible for the metabolism of more than 80% of the commercially available drugs.
Beta-blocker pharmacogenetics in heart failure.
Heart Fail Rev. 2010 May;15(3):187-96
Authors: Shin J, Johnson JA
Beta-blockers (metoprolol, bisoprolol, and carvedilol) are a cornerstone of heart failure (HF) treatment. However, it is well recognized that responses to a beta-blocker are variable among patients with HF.
FDA Partners with GlaxoSmithKline and Adaptive Pharmacogenomics to Advance Personalized Medicine
Pharmacogenetics of drug-induced liver injury.
Pharmacogenetics of drug-induced liver injury.
Hepatology. 2010 Apr 19;
Authors: Russmann S, Jetter A, Kullak-Ublick GA
Recent progress in research on drug-induced liver injury (DILI) has been determined by key developments in two areas. First, new technologies allow the identification of genetic risk factors with improved sensitivity, specificity, and efficiency.
Pharmacogenetics of drug transporters.
Curr Pharm Des. 2010;16(2):220-30
Authors: Franke RM, Gardner ER, Sparreboom A
During the last decade, a greater focus has been given to impact of genetic variation in membrane transporters on the pharmacokinetics and toxicity of numerous therapeutic drugs.