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Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute.

Journal of cellular biochemistry. Supplement

Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG.
PMID: 7616753
J Cell Biochem Suppl. 1994;20:55-62. doi: 10.1002/jcb.240560906.

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...

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Kelloff GJ, Crowell JA, Boone CW, et al. Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute. J Cell Biochem Suppl. 1994;20:55-62doi: 10.1002/jcb.240560906.
Kelloff, G. J., Crowell, J. A., Boone, C. W., Steele, V. E., Lubet, R. A., Greenwald, P., Alberts, D. S., Covey, J. M., Doody, L. A., & Knapp, G. G. (1994). Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute. Journal of cellular biochemistry. Supplement, 2055-62. https://doi.org/10.1002/jcb.240560906
Kelloff, G J, et al. "Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute." Journal of cellular biochemistry. Supplement vol. 20 (1994): 55-62. doi: https://doi.org/10.1002/jcb.240560906
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P, Alberts DS, Covey JM, Doody LA, Knapp GG. Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute. J Cell Biochem Suppl. 1994;20:55-62. doi: 10.1002/jcb.240560906. PMID: 7616753.
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Panel eases US drug approval process.

The Lancet. Oncology

Susman E.
PMID: 14974474
Lancet Oncol. 2004 Feb;5(2):71. doi: 10.1016/s1470-2045(04)01367-1.

No abstract available.

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Susman E. Panel eases US drug approval process. Lancet Oncol. 2004;5(2):71doi: 10.1016/s1470-2045(04)01367-1.
Susman, E. (2004). Panel eases US drug approval process. The Lancet. Oncology, 5(2), 71. https://doi.org/10.1016/s1470-2045(04)01367-1
Susman, Edward. "Panel eases US drug approval process." The Lancet. Oncology vol. 5,2 (2004): 71. doi: https://doi.org/10.1016/s1470-2045(04)01367-1
Susman E. Panel eases US drug approval process. Lancet Oncol. 2004 Feb;5(2):71. doi: 10.1016/s1470-2045(04)01367-1. PMID: 14974474.
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Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI.

The New England journal of medicine

Darrow JJ, Avorn J, Kesselheim AS.
PMID: 29211663
N Engl J Med. 2017 Dec 07;377(23):2278-2286. doi: 10.1056/NEJMhle1710706.

No abstract available.

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Darrow JJ, Avorn J, Kesselheim AS. Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI. N Engl J Med. 2017;377(23):2278-2286doi: 10.1056/NEJMhle1710706.
Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2017). Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI. The New England journal of medicine, 377(23), 2278-2286. https://doi.org/10.1056/NEJMhle1710706
Darrow, Jonathan J, et al. "Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI." The New England journal of medicine vol. 377,23 (2017): 2278-2286. doi: https://doi.org/10.1056/NEJMhle1710706
Darrow JJ, Avorn J, Kesselheim AS. Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI. N Engl J Med. 2017 Dec 07;377(23):2278-2286. doi: 10.1056/NEJMhle1710706. PMID: 29211663.
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A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?.

Journal of managed care & specialty pharmacy

Hung A, Vu Q, Mostovoy L.
PMID: 29172975
J Manag Care Spec Pharm. 2017 Dec;23(12):1234-1244. doi: 10.18553/jmcp.2017.23.12.1234.

BACKGROUND: Biosimilars undergo an abbreviated licensure pathway called 351(k), which was created by the Biologics Price Competition and Innovation Act of 2009. This approval process is different from the 351(a) pathway for original biologic approval and, as of August...

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Hung A, Vu Q, Mostovoy L. A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?. J Manag Care Spec Pharm. 2017;23(12):1234-1244doi: 10.18553/jmcp.2017.23.12.1234.
Hung, A., Vu, Q., & Mostovoy, L. (2017). A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?. Journal of managed care & specialty pharmacy, 23(12), 1234-1244. https://doi.org/10.18553/jmcp.2017.23.12.1234
Hung, Anna, et al. "A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?." Journal of managed care & specialty pharmacy vol. 23,12 (2017): 1234-1244. doi: https://doi.org/10.18553/jmcp.2017.23.12.1234
Hung A, Vu Q, Mostovoy L. A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?. J Manag Care Spec Pharm. 2017 Dec;23(12):1234-1244. doi: 10.18553/jmcp.2017.23.12.1234. PMID: 29172975.
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The next biotech superpower.

Nature biotechnology

[No authors listed]
PMID: 31690877
Nat Biotechnol. 2019 Nov;37(11):1243. doi: 10.1038/s41587-019-0316-7.

No abstract available.

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The next biotech superpower. Nat Biotechnol. 2019;37(11):1243doi: 10.1038/s41587-019-0316-7.
(2019). The next biotech superpower. Nature biotechnology, 37(11), 1243. https://doi.org/10.1038/s41587-019-0316-7
"The next biotech superpower." Nature biotechnology vol. 37,11 (2019): 1243. doi: https://doi.org/10.1038/s41587-019-0316-7
The next biotech superpower. Nat Biotechnol. 2019 Nov;37(11):1243. doi: 10.1038/s41587-019-0316-7. PMID: 31690877.
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Reforming China's drug regulatory system.

Nature reviews. Drug discovery

Xu L, Gao H, Kaitin KI, Shao L.
PMID: 30262888
Nat Rev Drug Discov. 2018 Dec;17(12):858-859. doi: 10.1038/nrd.2018.150. Epub 2018 Sep 28.

No abstract available.

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Xu L, Gao H, Kaitin KI, et al. Reforming China's drug regulatory system. Nat Rev Drug Discov. 2018;17(12):858-859doi: 10.1038/nrd.2018.150.
Xu, L., Gao, H., Kaitin, K. I., & Shao, L. (2018). Reforming China's drug regulatory system. Nature reviews. Drug discovery, 17(12), 858-859. https://doi.org/10.1038/nrd.2018.150
Xu, Lili, et al. "Reforming China's drug regulatory system." Nature reviews. Drug discovery vol. 17,12 (2018): 858-859. doi: https://doi.org/10.1038/nrd.2018.150
Xu L, Gao H, Kaitin KI, Shao L. Reforming China's drug regulatory system. Nat Rev Drug Discov. 2018 Dec;17(12):858-859. doi: 10.1038/nrd.2018.150. Epub 2018 Sep 28. PMID: 30262888.
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The needs of the few.

Nature

[No authors listed]
PMID: 20613796
Nature. 2010 Jul 08;466(7303):160. doi: 10.1038/466160a.

No abstract available.

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The needs of the few. Nature. 2010;466(7303):160doi: 10.1038/466160a.
(2010). The needs of the few. Nature, 466(7303), 160. https://doi.org/10.1038/466160a
"The needs of the few." Nature vol. 466,7303 (2010): 160. doi: https://doi.org/10.1038/466160a
The needs of the few. Nature. 2010 Jul 08;466(7303):160. doi: 10.1038/466160a. PMID: 20613796.
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New drugs 2011 part 1.

Nursing

Hussar DA.
PMID: 21217534
Nursing. 2011 Feb;41(2):32-40; quiz 40-2. doi: 10.1097/01.NURSE.0000393095.03101.bc.

No abstract available.

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Hussar DA. New drugs 2011 part 1. Nursing. 2011;41(2):32-40; quiz 40-2doi: 10.1097/01.NURSE.0000393095.03101.bc.
Hussar, D. A. (2011). New drugs 2011 part 1. Nursing, 41(2), 32-40; quiz 40-2. https://doi.org/10.1097/01.NURSE.0000393095.03101.bc
Hussar, Daniel A. "New drugs 2011 part 1." Nursing vol. 41,2 (2011): 32-40; quiz 40-2. doi: https://doi.org/10.1097/01.NURSE.0000393095.03101.bc
Hussar DA. New drugs 2011 part 1. Nursing. 2011 Feb;41(2):32-40; quiz 40-2. doi: 10.1097/01.NURSE.0000393095.03101.bc. PMID: 21217534.
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Drug pipeline: Q210.

Nature biotechnology

Peng W.
PMID: 20622824
Nat Biotechnol. 2010 Jul;28(7):640. doi: 10.1038/nbt0710-640.

No abstract available.

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Peng W. Drug pipeline: Q210. Nat Biotechnol. 2010;28(7):640doi: 10.1038/nbt0710-640.
Peng, W. (2010). Drug pipeline: Q210. Nature biotechnology, 28(7), 640. https://doi.org/10.1038/nbt0710-640
Peng, Wayne. "Drug pipeline: Q210." Nature biotechnology vol. 28,7 (2010): 640. doi: https://doi.org/10.1038/nbt0710-640
Peng W. Drug pipeline: Q210. Nat Biotechnol. 2010 Jul;28(7):640. doi: 10.1038/nbt0710-640. PMID: 20622824.
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[Health services research: essential for allocation decisions - joint statement].

Deutsche medizinische Wochenschrift (1946)

Pfaff H, Abholz H, Glaeske G, Icks A, Klinkhammer-Schalke M, Nellessen-Martens G, Neugebauer EA, Ohmann C, Schrappe M, Selbmann HK, Stemmer R.
PMID: 21993809
Dtsch Med Wochenschr. 2011 Dec;136(48):2496-500. doi: 10.1055/s-0031-1272579. Epub 2011 Oct 12.

No abstract available.

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Pfaff H, Abholz H, Glaeske G, et al. Versorgungsforschung: unverzichtbar bei Allokationsentscheidungen - eine Stellungnahme. [Health services research: essential for allocation decisions - joint statement]. Dtsch Med Wochenschr. 2011;136(48):2496-500doi: 10.1055/s-0031-1272579.
Pfaff, H., Abholz, H., Glaeske, G., Icks, A., Klinkhammer-Schalke, M., Nellessen-Martens, G., Neugebauer, E. A., Ohmann, C., Schrappe, M., Selbmann, H. K., Stemmer, R. (2011). Versorgungsforschung: unverzichtbar bei Allokationsentscheidungen - eine Stellungnahme. [Health services research: essential for allocation decisions - joint statement]. Deutsche medizinische Wochenschrift (1946), 136(48), 2496-500. https://doi.org/10.1055/s-0031-1272579
Pfaff, H, et al. "Versorgungsforschung: unverzichtbar bei Allokationsentscheidungen - eine Stellungnahme." [Health services research: essential for allocation decisions - joint statement]. Deutsche medizinische Wochenschrift (1946) vol. 136,48 (2011): 2496-500. doi: https://doi.org/10.1055/s-0031-1272579
Pfaff H, Abholz H, Glaeske G, Icks A, Klinkhammer-Schalke M, Nellessen-Martens G, Neugebauer EA, Ohmann C, Schrappe M, Selbmann HK, Stemmer R. Versorgungsforschung: unverzichtbar bei Allokationsentscheidungen - eine Stellungnahme. [Health services research: essential for allocation decisions - joint statement]. Dtsch Med Wochenschr. 2011 Dec;136(48):2496-500. doi: 10.1055/s-0031-1272579. Epub 2011 Oct 12. German. PMID: 21993809.
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Trouble at the office.

Nature biotechnology

Allison M.
PMID: 18779797
Nat Biotechnol. 2008 Sep;26(9):967-9. doi: 10.1038/nbt0908-967.

No abstract available.

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Allison M. Trouble at the office. Nat Biotechnol. 2008;26(9):967-9doi: 10.1038/nbt0908-967.
Allison, M. (2008). Trouble at the office. Nature biotechnology, 26(9), 967-9. https://doi.org/10.1038/nbt0908-967
Allison, Malorye. "Trouble at the office." Nature biotechnology vol. 26,9 (2008): 967-9. doi: https://doi.org/10.1038/nbt0908-967
Allison M. Trouble at the office. Nat Biotechnol. 2008 Sep;26(9):967-9. doi: 10.1038/nbt0908-967. PMID: 18779797.
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Market withdrawal of new molecular entities approved in the United States from 1980 to 2009.

Pharmacoepidemiology and drug safety

Qureshi ZP, Seoane-Vazquez E, Rodriguez-Monguio R, Stevenson KB, Szeinbach SL.
PMID: 21574210
Pharmacoepidemiol Drug Saf. 2011 Jul;20(7):772-7. doi: 10.1002/pds.2155. Epub 2011 May 14.

PURPOSE: Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the...

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Qureshi ZP, Seoane-Vazquez E, Rodriguez-Monguio R, et al. Market withdrawal of new molecular entities approved in the United States from 1980 to 2009. Pharmacoepidemiol Drug Saf. 2011;20(7):772-7doi: 10.1002/pds.2155.
Qureshi, Z. P., Seoane-Vazquez, E., Rodriguez-Monguio, R., Stevenson, K. B., & Szeinbach, S. L. (2011). Market withdrawal of new molecular entities approved in the United States from 1980 to 2009. Pharmacoepidemiology and drug safety, 20(7), 772-7. https://doi.org/10.1002/pds.2155
Qureshi, Zaina P, et al. "Market withdrawal of new molecular entities approved in the United States from 1980 to 2009." Pharmacoepidemiology and drug safety vol. 20,7 (2011): 772-7. doi: https://doi.org/10.1002/pds.2155
Qureshi ZP, Seoane-Vazquez E, Rodriguez-Monguio R, Stevenson KB, Szeinbach SL. Market withdrawal of new molecular entities approved in the United States from 1980 to 2009. Pharmacoepidemiol Drug Saf. 2011 Jul;20(7):772-7. doi: 10.1002/pds.2155. Epub 2011 May 14. PMID: 21574210.
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Showing 1 to 12 of 39 entries