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1.
Clin Chem Lab Med ; 45(7): 843-50, 2007.
Article in English | MEDLINE | ID: mdl-17617025

ABSTRACT

This workshop discussed the use of pharmacogenomics knowledge in clinical practice. It was organized in three sections: educational needs, definition of industry as a potential trigger, and regulatory aspects. Regarding pharmacogenomics education, it appears that this is truly lacking, except for patients, who are becoming increasingly educated thanks to the media. Regarding administrators, education is mainly a problem of cost. Indeed, even if cost-effective for society on the whole, pharmacogenomic tests will be expensive for hospitals. Physicians are facing an overabundance of information. They must be helped to bridge the gap between knowledge/research and clinical application. Collaboration between the pharmaceutical industry and the diagnostics industry could be one of the triggers. Moreover, there is a lack of qualification of this information, even though some guidelines are being produced. The Food and Drug Administration organizes workshops that often lead to publications on pharmacogenomic education, genomic data aims and development concepts, which can finally be translated into guidelines. Industry can contribute to pharmacogenomic development, not only through research, but also through marketing activities, which would promote the use of pharmacogenomics by physicians. Legal aspects were also considered in terms of the problem of availability and the degree of qualification of commercial drug tests on the market. The Innovative Medicine Initiative was also presented, which is a public-private partnership to create a biomedical research and development leader to benefit patients and society. Finally, a technical report from the Institute for Prospective Technological Studies on the socioeconomic impact of pharmacogenomics in the EU was presented.


Subject(s)
Drug Industry , Pharmacogenetics , Drug Industry/education , Drug Industry/trends , Health Services Needs and Demand , Humans , International Cooperation , Pharmacogenetics/education , Pharmacogenetics/methods , United States , United States Food and Drug Administration/legislation & jurisprudence
2.
Clin Chem Lab Med ; 43(12): 1303-13, 2005.
Article in English | MEDLINE | ID: mdl-16309365

ABSTRACT

BACKGROUND: Proteomics' requirement for simultaneous measurement of multiple markers is now possible with biochip array technology. Many laboratories utilise in-house, manual procedures for biochip fabrication and sample testing. Reproducibility and standardisation of biochip processes is vital to ensure quality of results and offer the best tool for elucidation of complex relationships between multiple proteins in diseased conditions. METHODS: Various novel control checks have been implemented in biochip fabrication, reagent manufacture, automation and imaging processes for the Evidence analyser. Reference spots enable location of discrete test regions on the surface of the biochip and simultaneous quantification of multiple markers. Performance and standardisation methods are presented. RESULTS: Formulation of dispense solution for discrete test regions had a direct effect on their shape, stability and integrity on the biochip surface. Assays for fertility hormones and drugs of abuse demonstrated excellent precision, stability and comparison with other commercial methods. CONCLUSION: Control processes employed in the manufacture and analysis of Evidence components ensure reproducibility of assays for a range of routine and novel markers.


Subject(s)
Biosensing Techniques/methods , Clinical Laboratory Techniques , Protein Array Analysis/methods , Quality Control , Animals , Autoanalysis , Biomarkers/analysis , Cytokines/analysis , Cytokines/standards , Fertility/drug effects , Fertility/physiology , Hormones/metabolism , Hormones/pharmacology , Humans , Proteomics/methods , Reproducibility of Results , Research Design , Sensitivity and Specificity , Substance-Related Disorders/metabolism
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