The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.
The FDA Critical Path Initiative and Its Influence on New Drug Development
Abstract
Societal expectations about drug safety and efficacy are rising while productivity in the pharmaceutical industry is falling. In 2004, the US Food and Drug Administration introduced the Critical Path Initiative with the intent of modernizing drug development by incorporating recent scientific advances, such as genomics and advanced imaging technologies, into the process. An important part of the initiative is the use of public-private partnerships and consortia to accomplish the needed research. This article explicates the reasoning behind the Critical Path Initiative and discusses examples of successful consortia.
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Cites
The price of innovation: new estimates of drug development costs
DiMasi, J. A., Hansen, R. W., & Grabowski, H. G. (2003) · Journal of Health Economics · doi:10.1016/s0167-6296(02)00126-1 · Cited by 4,265
Estimating The Cost Of New Drug Development: Is It Really $802 Million?
Adams, C. P., & Brantner, V. V. (2006) · Health Affairs · doi:10.1377/hlthaff.25.2.420 · Cited by 907
The Prospects for “Personalized Medicine” in Drug Development and Drug Therapy
Woodcock, J. (2007) · Clinical Pharmacology & Therapeutics · doi:10.1038/sj.clpt.6100063 · Cited by 179
Self-citationAntiretroviral Drug–Based Microbicides to Prevent HIV-1 Sexual Transmission
Klasse, P. J., Shattock, R., & Moore, J. P. (2008) · Annual Review of Medicine · doi:10.1146/annurev.med.59.061206.112737 · Cited by 178
A Proposal for Radical Changes in the Drug-Approval Process
Wood, A. J. J. (2006) · New England Journal of Medicine · doi:10.1056/nejmsb055203 · Cited by 113
Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision?
Lesko, L. J. (2007) · Clinical Pharmacology & Therapeutics · doi:10.1038/sj.clpt.6100045 · Cited by 94
The Drug Development Crisis: Efficiency and Safety
Caskey, C. T. (2006) · Annual Review of Medicine · doi:10.1146/annurev.med.58.042705.124037 · Cited by 61
Curbing The Cardiovascular Disease Epidemic: Aligning Industry, Government, Payers, And Academics
Califf, R. M., Harrington, R. A., Madre, L. K., Peterson, E. D., Roth, D., & Schulman, K. A. (2007) · Health Affairs · doi:10.1377/hlthaff.26.1.62 · Cited by 33
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Seok, J., Warren, H. S., Cuenca, A. G., Mindrinos, M. N., Baker, H. V., Xu, W., Richards, D. R., McDonald-Smith, G. P., Gao, H., Hennessy, L., et al. (2013) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1222878110 · Cited by 3,005
Imaging biomarker roadmap for cancer studies
O'Connor, J. P. B., Aboagye, E. O., Adams, J. E., Aerts, H. J. W. L., Barrington, S. F., Beer, A. J., Boellaard, R., Bohndiek, S. E., Brady, M., Brown, G., et al. (2017) · Nature Reviews Clinical Oncology · doi:10.1038/nrclinonc.2016.162 · Cited by 1,091
Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives
Hampel, H., Frank, R., Broich, K., Teipel, S. J., Katz, R. G., Hardy, J., Herholz, K., Bokde, A. L. W., Jessen, F., Hoessler, Y. C., et al. (2010) · Nature Reviews Drug Discovery · doi:10.1038/nrd3115 · Cited by 631
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Rathore, A. S. (2009) · Trends in Biotechnology · doi:10.1016/j.tibtech.2009.06.006 · Cited by 411
Pharmacokinetic-Pharmacodynamic Modeling of Antibacterial Drugs
Nielsen, E. I., & Friberg, L. E. (2013) · Pharmacological Reviews · doi:10.1124/pr.111.005769 · Cited by 332
Metadata
- Authors
- Woodcock, J., & Woosley, R.
- Venue
- Annual Review of Medicine
- Publisher
- Annual Reviews
- Published
- 2008-02-01
- Volume
- 59
- Issue
- 1
- Pages
- 1-12
- ISSN
- 0066-4219 (ISSN-L)
- 1545-326X
- OpenAlex
- W2143548516
- Cited by
- 434
- References
- 8
- FWCI
- 66.74
- Type
- journal article
- Language
- en
- Open access
- closed
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
