Abstract
At the National Cancer Institute, Division of Cancer Prevention and Control, the Chemoprevention Branch and Agent Development Committee develop strategies for efficiently identifying, procuring, and advancing the most promising drugs into clinical trials. Scientific expertise is applied at each phase of development to critically review the testing methods and results, and to establish and apply criteria for evaluating the agents for further development. The Clinical Development Plan, prepared by the Chemoprevention Branch and the Agent Development Committee, is a summary of the status of the agent regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. It also contains the strategy for further development of the drug that addresses pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen Clinical Development Plans are presented here: N-acetyl-l-cysteine (NAC), aspirin, calcium, beta-carotene, 2-difluoromethylornithine (DFMO), DHEA analog 8354, 18 beta-glycyrrhetinic acid, N-(4-hydroxyphenyl)retinamide (4-HPR), ibuprofen, oltipraz, piroxicam, Proscar, sulindac, tamoxifen, vitamin D3 and analogs, and vitamin E. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing chemopreventive drugs.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 55-62 |
| Number of pages | 8 |
| Journal | Journal of cellular biochemistry. Supplement |
| Volume | 20 |
| State | Published - 1994 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Medicine(all)
Cite this
Strategy and planning for chemopreventive drug development : clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute. / Kelloff, G. J.; Crowell, J. A.; Boone, C. W.; Steele, V. E.; Lubet, R. A.; Greenwald, P.; Alberts, David S; Covey, J. M.; Doody, L. A.; Knapp, G. G.
In: Journal of cellular biochemistry. Supplement, Vol. 20, 1994, p. 55-62.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Strategy and planning for chemopreventive drug development
T2 - clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute.
AU - Kelloff, G. J.
AU - Crowell, J. A.
AU - Boone, C. W.
AU - Steele, V. E.
AU - Lubet, R. A.
AU - Greenwald, P.
AU - Alberts, David S
AU - Covey, J. M.
AU - Doody, L. A.
AU - Knapp, G. G.
PY - 1994
Y1 - 1994
N2 - At the National Cancer Institute, Division of Cancer Prevention and Control, the Chemoprevention Branch and Agent Development Committee develop strategies for efficiently identifying, procuring, and advancing the most promising drugs into clinical trials. Scientific expertise is applied at each phase of development to critically review the testing methods and results, and to establish and apply criteria for evaluating the agents for further development. The Clinical Development Plan, prepared by the Chemoprevention Branch and the Agent Development Committee, is a summary of the status of the agent regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. It also contains the strategy for further development of the drug that addresses pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen Clinical Development Plans are presented here: N-acetyl-l-cysteine (NAC), aspirin, calcium, beta-carotene, 2-difluoromethylornithine (DFMO), DHEA analog 8354, 18 beta-glycyrrhetinic acid, N-(4-hydroxyphenyl)retinamide (4-HPR), ibuprofen, oltipraz, piroxicam, Proscar, sulindac, tamoxifen, vitamin D3 and analogs, and vitamin E. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing chemopreventive drugs.
AB - At the National Cancer Institute, Division of Cancer Prevention and Control, the Chemoprevention Branch and Agent Development Committee develop strategies for efficiently identifying, procuring, and advancing the most promising drugs into clinical trials. Scientific expertise is applied at each phase of development to critically review the testing methods and results, and to establish and apply criteria for evaluating the agents for further development. The Clinical Development Plan, prepared by the Chemoprevention Branch and the Agent Development Committee, is a summary of the status of the agent regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. It also contains the strategy for further development of the drug that addresses pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen Clinical Development Plans are presented here: N-acetyl-l-cysteine (NAC), aspirin, calcium, beta-carotene, 2-difluoromethylornithine (DFMO), DHEA analog 8354, 18 beta-glycyrrhetinic acid, N-(4-hydroxyphenyl)retinamide (4-HPR), ibuprofen, oltipraz, piroxicam, Proscar, sulindac, tamoxifen, vitamin D3 and analogs, and vitamin E. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing chemopreventive drugs.
UR - http://www.scopus.com/inward/record.url?scp=0028701027&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0028701027&partnerID=8YFLogxK
M3 - Article
VL - 20
SP - 55
EP - 62
JO - Journal of cellular biochemistry. Supplement
JF - Journal of cellular biochemistry. Supplement
SN - 0733-1959
ER -