genomics, proteomics, and metabolomics; human studies to validate bio-markers in adequately sized longitudinal studies; and definition of appropriate institutional roles in the development of standards. Such initiatives are beyond the capability of either the FDA or most private companies unless they work together within a collaborative framework.

REFERENCES

FDA (Food and Drug Administration). 1997. International conference harmonization guidance for industry: S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals. http://www.fda.gov/cder/guidance/1859fnl.pdf (accessed October 17, 2008).

FDA. 2001. International conference harmonization guidance for industry: S7A safety pharmacology studies for human pharmaceuticals. http://www.fda.gov/Cber/gdlns/ichs7a071201.pdf (accessed October 17, 2008).

FDA. 2002. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Preliminary concept paper. http://www.fda.gov/ohrms/dockets/ac/03/briefing/pubs%5Cprelim.pdf (accessed October 17, 2008).

FDA. 2005a. International conference harmonization guidance for industry: E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. http://www.fda.gov/cber/gdlns/iche14qtc.pdf (accessed October 17,(accessed October 17, 2008).

FDA. 2005b. International conference harmonization guidance for industry: S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. http://www.fda.gov/cder/guidance/5533dft.htm (accessed October 17, 2008).



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