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Showing 1 to 12 of 23 entries
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Obstacles and opportunities in Chinese pharmaceutical innovation.

Globalization and health

Ni J, Zhao J, Ung CO, Hu Y, Hu H, Wang Y.
PMID: 28340579
Global Health. 2017 Mar 24;13(1):21. doi: 10.1186/s12992-017-0244-6.

BACKGROUND: Global healthcare innovation networks nowadays have expanded beyond developed countries with many developing countries joining the force and becoming important players. China, in particular, has seen a significant increase in the number of innovative firms and research organizations...

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Ni J, Zhao J, Ung CO, et al. Obstacles and opportunities in Chinese pharmaceutical innovation. Global Health. 2017;13(1):21doi: 10.1186/s12992-017-0244-6.
Ni, J., Zhao, J., Ung, C. O., Hu, Y., Hu, H., & Wang, Y. (2017). Obstacles and opportunities in Chinese pharmaceutical innovation. Globalization and health, 13(1), 21. https://doi.org/10.1186/s12992-017-0244-6
Ni, Jingyun, et al. "Obstacles and opportunities in Chinese pharmaceutical innovation." Globalization and health vol. 13,1 (2017): 21. doi: https://doi.org/10.1186/s12992-017-0244-6
Ni J, Zhao J, Ung CO, Hu Y, Hu H, Wang Y. Obstacles and opportunities in Chinese pharmaceutical innovation. Global Health. 2017 Mar 24;13(1):21. doi: 10.1186/s12992-017-0244-6. PMID: 28340579; PMCID: PMC5366105.
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The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary?.

Clinical pharmacology and therapeutics

McCamish M, Woollett G.
PMID: 23443756
Clin Pharmacol Ther. 2013 Apr;93(4):315-7. doi: 10.1038/clpt.2013.17. Epub 2013 Jan 25.

Experts debate the clinical evidence standards needed to approve major manufacturing changes for biologics, biosimilars, and interchangeable biosimilars. As sponsors consider their development plans, the resource investment required to develop an analytically highly similar candidate must be balanced by...

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McCamish M, Woollett G. The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary?. Clin Pharmacol Ther. 2013;93(4):315-7doi: 10.1038/clpt.2013.17.
McCamish, M., & Woollett, G. (2013). The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary?. Clinical pharmacology and therapeutics, 93(4), 315-7. https://doi.org/10.1038/clpt.2013.17
McCamish, M, and Woollett, G. "The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary?." Clinical pharmacology and therapeutics vol. 93,4 (2013): 315-7. doi: https://doi.org/10.1038/clpt.2013.17
McCamish M, Woollett G. The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary?. Clin Pharmacol Ther. 2013 Apr;93(4):315-7. doi: 10.1038/clpt.2013.17. Epub 2013 Jan 25. PMID: 23443756; PMCID: PMC3604642.
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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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Stakeholders discuss biosimilar naming, substitution.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists

Traynor K.
PMID: 24589534
Am J Health Syst Pharm. 2014 Mar 15;71(6):446-7. doi: 10.2146/news140023.

No abstract available.

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Traynor K. Stakeholders discuss biosimilar naming, substitution. Am J Health Syst Pharm. 2014;71(6):446-7doi: 10.2146/news140023.
Traynor, K. (2014). Stakeholders discuss biosimilar naming, substitution. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 71(6), 446-7. https://doi.org/10.2146/news140023
Traynor, Kate. "Stakeholders discuss biosimilar naming, substitution." American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists vol. 71,6 (2014): 446-7. doi: https://doi.org/10.2146/news140023
Traynor K. Stakeholders discuss biosimilar naming, substitution. Am J Health Syst Pharm. 2014 Mar 15;71(6):446-7. doi: 10.2146/news140023. PMID: 24589534.
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Letter from the Commissioner's Office at the US FDA.

PharmacoEconomics

Vernon JA.
PMID: 17402801
Pharmacoeconomics. 2007;25(4):267-8. doi: 10.2165/00019053-200725040-00001.

No abstract available.

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Vernon JA. Letter from the Commissioner's Office at the US FDA. Pharmacoeconomics. 2007;25(4):267-8doi: 10.2165/00019053-200725040-00001.
Vernon, J. A. (2007). Letter from the Commissioner's Office at the US FDA. PharmacoEconomics, 25(4), 267-8. https://doi.org/10.2165/00019053-200725040-00001
Vernon, John A. "Letter from the Commissioner's Office at the US FDA." PharmacoEconomics vol. 25,4 (2007): 267-8. doi: https://doi.org/10.2165/00019053-200725040-00001
Vernon JA. Letter from the Commissioner's Office at the US FDA. Pharmacoeconomics. 2007;25(4):267-8. doi: 10.2165/00019053-200725040-00001. PMID: 17402801.
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Evidence of comparative efficacy should have a formal role in European drug approvals.

BMJ (Clinical research ed.)

Sorenson C, Naci H, Cylus J, Mossialos E.
PMID: 21896610
BMJ. 2011 Sep 06;343:d4849. doi: 10.1136/bmj.d4849.

No abstract available.

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Sorenson C, Naci H, Cylus J, et al. Evidence of comparative efficacy should have a formal role in European drug approvals. BMJ. 2011;343:d4849doi: 10.1136/bmj.d4849.
Sorenson, C., Naci, H., Cylus, J., & Mossialos, E. (2011). Evidence of comparative efficacy should have a formal role in European drug approvals. BMJ (Clinical research ed.), 343d4849. https://doi.org/10.1136/bmj.d4849
Sorenson, Corinna, et al. "Evidence of comparative efficacy should have a formal role in European drug approvals." BMJ (Clinical research ed.) vol. 343 (2011): d4849. doi: https://doi.org/10.1136/bmj.d4849
Sorenson C, Naci H, Cylus J, Mossialos E. Evidence of comparative efficacy should have a formal role in European drug approvals. BMJ. 2011 Sep 06;343:d4849. doi: 10.1136/bmj.d4849. PMID: 21896610.
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From the editors' desk: disparities near and far.

Journal of general internal medicine

Kravitz RL, Feldman MD.
PMID: 21279457
J Gen Intern Med. 2011 Mar;26(3):229. doi: 10.1007/s11606-010-1625-1.

No abstract available.

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Kravitz RL, Feldman MD. From the editors' desk: disparities near and far. J Gen Intern Med. 2011;26(3):229doi: 10.1007/s11606-010-1625-1.
Kravitz, R. L., & Feldman, M. D. (2011). From the editors' desk: disparities near and far. Journal of general internal medicine, 26(3), 229. https://doi.org/10.1007/s11606-010-1625-1
Kravitz, Richard L, and Feldman, Mitchell D. "From the editors' desk: disparities near and far." Journal of general internal medicine vol. 26,3 (2011): 229. doi: https://doi.org/10.1007/s11606-010-1625-1
Kravitz RL, Feldman MD. From the editors' desk: disparities near and far. J Gen Intern Med. 2011 Mar;26(3):229. doi: 10.1007/s11606-010-1625-1. PMID: 21279457; PMCID: PMC3043191.
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FDA: friend or foe?.

Medical device technology

Lewis TS.
PMID: 10163675
Med Device Technol. 1996 Nov;7(9):24-30.

Delays in FDA product approvals have weakened the US medical device market. Reduced investment returns and the erosion of industry's confidence in FDA procedures have slowed the introduction of new products and threatened the market's potential for growth. This...

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Lewis TS. FDA: friend or foe?. Med Device Technol. 1996;7(9):24-30
Lewis, T. S. (1996). FDA: friend or foe?. Medical device technology, 7(9), 24-30.
Lewis, T S. "FDA: friend or foe?." Medical device technology vol. 7,9 (1996): 24-30.
Lewis TS. FDA: friend or foe?. Med Device Technol. 1996 Nov;7(9):24-30. PMID: 10163675.
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The rise of biosimilars: How they got here and where they are going.

Metabolism: clinical and experimental

Patel D, Gillis C, Naggar J, Mistry A, Mantzoros CS.
PMID: 28939017
Metabolism. 2017 Oct;75:45-53. doi: 10.1016/j.metabol.2017.07.008. Epub 2017 Aug 07.

Biosimilars have become a subject of great interest in the past few years. The European Union and the United States are seeing an increasing number of biosimilar applications and approvals. The development of a biosimilar is significantly more complex...

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Patel D, Gillis C, Naggar J, et al. The rise of biosimilars: How they got here and where they are going. Metabolism. 2017;75:45-53doi: 10.1016/j.metabol.2017.07.008.
Patel, D., Gillis, C., Naggar, J., Mistry, A., & Mantzoros, C. S. (2017). The rise of biosimilars: How they got here and where they are going. Metabolism: clinical and experimental, 7545-53. https://doi.org/10.1016/j.metabol.2017.07.008
Patel, Dhiren, et al. "The rise of biosimilars: How they got here and where they are going." Metabolism: clinical and experimental vol. 75 (2017): 45-53. doi: https://doi.org/10.1016/j.metabol.2017.07.008
Patel D, Gillis C, Naggar J, Mistry A, Mantzoros CS. The rise of biosimilars: How they got here and where they are going. Metabolism. 2017 Oct;75:45-53. doi: 10.1016/j.metabol.2017.07.008. Epub 2017 Aug 07. PMID: 28939017.
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German body calls for pause in European plan for fast track drug approval.

BMJ (Clinical research ed.)

Hawkes N.
PMID: 27530526
BMJ. 2016 Aug 16;354:i4479. doi: 10.1136/bmj.i4479.

No abstract available.

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Hawkes N. German body calls for pause in European plan for fast track drug approval. BMJ. 2016;354:i4479doi: 10.1136/bmj.i4479.
Hawkes, N. (2016). German body calls for pause in European plan for fast track drug approval. BMJ (Clinical research ed.), 354i4479. https://doi.org/10.1136/bmj.i4479
Hawkes, Nigel. "German body calls for pause in European plan for fast track drug approval." BMJ (Clinical research ed.) vol. 354 (2016): i4479. doi: https://doi.org/10.1136/bmj.i4479
Hawkes N. German body calls for pause in European plan for fast track drug approval. BMJ. 2016 Aug 16;354:i4479. doi: 10.1136/bmj.i4479. PMID: 27530526.
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Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source.

Journal of clinical epidemiology

Withycombe B, Ovenell M, Meeker A, Ahmed SM, Hartung DM.
PMID: 27108488
J Clin Epidemiol. 2016 Sep;77:78-83. doi: 10.1016/j.jclinepi.2016.04.007. Epub 2016 Apr 22.

OBJECTIVE: The study aimed to characterize the public availability of pivotal clinical trial results for newly approved drugs.STUDY DESIGN AND SETTING: We examined the availability of pivotal clinical trial results for new molecular entities (NMEs) approved by the US...

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Withycombe B, Ovenell M, Meeker A, et al. Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source. J Clin Epidemiol. 2016;77:78-83doi: 10.1016/j.jclinepi.2016.04.007.
Withycombe, B., Ovenell, M., Meeker, A., Ahmed, S. M., & Hartung, D. M. (2016). Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source. Journal of clinical epidemiology, 7778-83. https://doi.org/10.1016/j.jclinepi.2016.04.007
Withycombe, Bethany, et al. "Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source." Journal of clinical epidemiology vol. 77 (2016): 78-83. doi: https://doi.org/10.1016/j.jclinepi.2016.04.007
Withycombe B, Ovenell M, Meeker A, Ahmed SM, Hartung DM. Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source. J Clin Epidemiol. 2016 Sep;77:78-83. doi: 10.1016/j.jclinepi.2016.04.007. Epub 2016 Apr 22. PMID: 27108488.
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Evaluating the safety of diabetes drugs: perspective of a Food and Drug Administration insider.

Diabetes care

Misbin RI.
PMID: 16186303
Diabetes Care. 2005 Oct;28(10):2573-6. doi: 10.2337/diacare.28.10.2573.

No abstract available.

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Misbin RI. Evaluating the safety of diabetes drugs: perspective of a Food and Drug Administration insider. Diabetes Care. 2005;28(10):2573-6doi: 10.2337/diacare.28.10.2573.
Misbin, R. I. (2005). Evaluating the safety of diabetes drugs: perspective of a Food and Drug Administration insider. Diabetes care, 28(10), 2573-6. https://doi.org/10.2337/diacare.28.10.2573
Misbin, Robert I. "Evaluating the safety of diabetes drugs: perspective of a Food and Drug Administration insider." Diabetes care vol. 28,10 (2005): 2573-6. doi: https://doi.org/10.2337/diacare.28.10.2573
Misbin RI. Evaluating the safety of diabetes drugs: perspective of a Food and Drug Administration insider. Diabetes Care. 2005 Oct;28(10):2573-6. doi: 10.2337/diacare.28.10.2573. PMID: 16186303.
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Showing 1 to 12 of 23 entries