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References
- ↑ Woosley, R. L. "The FDA’s Critical Path Initiative." Archived 2010-10-26 at the Wayback Machine PharmacoVigilance Review 1.3 (August 2007): 16-18
- ↑ U.S. Food and Drug Administration. The Critical Path Initiative: Transforming the Way FDA-Regulated Products are Developed, Evaluated, Manufactured, and Used April 2009
- ↑ FDA: Paving the Pathway for Innovation Archived 2011-06-11 at the Wayback Machine
- 1 2 3 Woodcock, J; Woosley, R (2008). "The FDA critical path initiative and its influence on new drug development". Annual Review of Medicine. 59: 1–12. doi:10.1146/annurev.med.59.090506.155819. PMID 18186700.
- ↑ "18 Ideas to Reform Health Care Now." Reader's Digest, November 2008.
- ↑ Coons, Stephen Joel (2009). "The FDA's critical path initiative: A brief introduction". Clinical Therapeutics. 31 (11): 2572–3. doi: 10.1016/j.clinthera.2009.11.035 . PMID 20110002.
- ↑ Woosley, R. L.; Cossman, J. (2007). "Drug Development and the FDA's Critical Path Initiative" (PDF). Clinical Pharmacology & Therapeutics. 81 (1): 129–33. doi:10.1038/sj.clpt.6100014. PMID 17186012. S2CID 37481486.
- ↑ Mattes, William B. (2008). "Public Consortium Efforts in Toxicogenomics". In Mendrick, Donna L.; Mattes, William B. (eds.). Essential Concepts in Toxicogenomics. Methods in Molecular Biology. Vol. 460. pp. 221–238. doi:10.1007/978-1-60327-048-9_11. ISBN 978-1-58829-638-2. PMID 18449490.
- ↑ Goodsaid, FM; Frueh, FW; Mattes, W (2008). "Strategic paths for biomarker qualification". Toxicology. 245 (3): 219–23. doi:10.1016/j.tox.2007.12.023. PMID 18280028.
- ↑ "Critical Path Initiative". Fda.gov. Retrieved 2011-03-27. Cite web requires |website= (help) [ verification needed ]
- ↑ Woosley, RL; Myers, RT; Goodsaid, F (2010). "The Critical Path Institute's Approach to Precompetitive Sharing and Advancing Regulatory Science". Clinical Pharmacology & Therapeutics. 87 (5): 530–3. doi:10.1038/clpt.2010.27. PMID 20407457. S2CID 36643880.
- ↑ "FDA Announces Partnership with Critical Path Institute to Conduct Essential Research to Spur Medical Innovation"
- ↑ Ismail, Kola; Landis, John (2004). "Opinion: Can the pharmaceutical industry reduce attrition rates?". Nature Reviews Drug Discovery. 3 (8): 711–6. doi:10.1038/nrd1470. PMID 15286737. S2CID 25634768.
- 1 2 U.S. Department of Health and Human Services Food and Drug Administration. "Innovation or Stagnation: Challenges and Opportunity on the Critical Path to New Medical Products." March 2004.
- ↑ Goodsaid, F. M., F. W. Frueh, and W. B. Mattes. "The Predictive Safety Testing Consortium: A Synthesis of the Goals, Challenges and Accomplishments of the Critical Path." Drug Discovery Today: Technologies 4.2(2007): 47-50
- ↑ Mattes, WB; Walker, EG (2009). "Translational toxicology and the work of the predictive safety testing consortium". Clinical Pharmacology and Therapeutics. 85 (3): 327–30. doi:10.1038/clpt.2008.270. PMID 19158666. S2CID 205120844.
- ↑ "The Critical Path to TB Regimens Initiative". Tballiance.org. Archived from the original on 2011-04-27. Retrieved 2011-03-27.
- ↑ "Mayo Clinic Translational Polycystic Kidney Disease (PKD) Center;" "Building a Drug Development Machine." Archived 2011-01-16 at the Wayback Machine
- 1 2 Romero, K; De Mars, M; Frank, D; Anthony, M; Neville, J; Kirby, L; Smith, K; Woosley, RL (2009). "The Coalition Against Major Diseases: developing tools for an integrated drug development process for Alzheimer's and Parkinson's diseases". Clinical Pharmacology and Therapeutics. 86 (4): 365–7. doi:10.1038/clpt.2009.165. PMID 19763117. S2CID 28813390.
- ↑ "People | Critical Path Institute". c-path.org. Retrieved 2019-08-10.