Science & Research
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Publications
- Models and approaches for anti-TB drug testing, Expert Reviews of Anti-infective Therapy, 9(7), 823-831, Sacks, Leonard, Yasinskaya, Yulia, July 2011
- Advancing the development of diagnostic tests and biomarkers for tuberculosis, The International Journal of Tuberculosis and Lung Disease, Vol. 15, Number 7, pp. 985-987(3), Sacks, Leonard, Yasinskaya, Yulia, July 2011
- Of Genomics and Bioinformatics, The Pharmacogenomics Journal, August 2010
According to this editorial in the August 2010 issue of Nature Biotechnology, the MAQC consortium's latest study suggests that human error in handling DNA microarray data analysis software could delay the technology's wider adoption in the clinic. (See FDA's Web page MicroArray Quality Control for background on the project)
Challenges, successes and hopes in the development of novel TB therapeutics, Future Medicinal Chemistry, 1(4), 749-756, Sacks, Leonard, Behrman, Rachel, July 2009.
- FDA Critical Path project publishes article on Improving the Safety and Efficacy of Adenovirus Gene Therapy, June 2009
- The FDA Critical Path Initiative and Its Influence on New Drug Development, Annual Review of Medicine, Vol. 59, DOI: 10.1146/annurev.med.59.09056.155819, Woodcock, Janet, Woosley, Raymond, Feb, 2008
- Bioinformatics Modernization and the Critical Path to Improved Benefit-Risk Assessment of Drugs, 2008
- Developing new drugs for the treatment of drug resistant tuberculosis: a regulatory perspective, 2008
- FDA's Proactive Role in the Development of an Artificial Pancreas for the Treatment of Diabetes Mellitus, 2007
- Metabolomic biomarkers: their role in the critical path, 2007
- Assessment of visual performance in the evaluation of new medical products, 2007
- Blood safety: Opportunities and challenges addressed through Critical Path research at FDA, 2007
- The pharmacology of electrical stimulation in the heart: Where devices meet drugs, 2007
Presentations
Reports
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