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Items: 1 to 50 of 62

1.

Artificial Intelligence and Patient-centric Approaches to Advance Pharmaceutical Innovation.

Kaitin KI.

Clin Ther. 2019 Jul 25. pii: S0149-2918(19)30341-8. doi: 10.1016/j.clinthera.2019.06.014. [Epub ahead of print] No abstract available.

PMID:
31353132
2.

Are Regulation and Innovation Priorities Serving Public Health Needs?

Milne CP, Kaitin KI.

Front Pharmacol. 2019 Mar 8;10:144. doi: 10.3389/fphar.2019.00144. eCollection 2019. Review.

3.

Efficacy and Effectiveness Too Trials: Clinical Trial Designs to Generate Evidence on Efficacy and on Effectiveness in Wide Practice.

Selker HP, Eichler HG, Stockbridge NL, McElwee NE, Dere WH, Cohen T, Erban JK, Seyfert-Margolis VL, Honig PK, Kaitin KI, Oye KA, D'Agostino RB Sr.

Clin Pharmacol Ther. 2019 Apr;105(4):857-866. doi: 10.1002/cpt.1347. Epub 2019 Feb 12.

4.

Regenerative Medicine at the Forefront of Innovation: Update From Japan.

Milne CP, Kaitin KI.

Clin Ther. 2018 Nov;40(11):1798-1800. doi: 10.1016/j.clinthera.2018.10.005. Epub 2018 Oct 28. No abstract available.

PMID:
30376963
5.

Reforming China's drug regulatory system.

Xu L, Gao H, Kaitin KI, Shao L.

Nat Rev Drug Discov. 2018 Dec;17(12):858-859. doi: 10.1038/nrd.2018.150. Epub 2018 Sep 28. No abstract available.

PMID:
30262888
6.

EFFICACY-TO-EFFECTIVENESS CLINICAL TRIALS.

Selker HP, Gorman S, Kaitin KI.

Trans Am Clin Climatol Assoc. 2018;129:279-300.

7.

Challenge and Change at the Forefront of Regenerative Medicine.

Milne CP, Kaitin KI.

Clin Ther. 2018 Jul;40(7):1056-1059. doi: 10.1016/j.clinthera.2018.06.008. Epub 2018 Jul 10. No abstract available.

PMID:
30006070
8.

Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities.

Beierlein JM, McNamee LM, Walsh MJ, Kaitin KI, DiMasi JA, Ledley FD.

Clin Ther. 2017 Jul;39(7):1409-1425.e20. doi: 10.1016/j.clinthera.2017.06.001. Epub 2017 Jun 23.

PMID:
28652015
9.

Developing New Medicines for Pediatric Oncology: Assessing Needs and Overcoming Challenges.

Kaitin KI.

Clin Ther. 2017 Feb;39(2):236-237. doi: 10.1016/j.clinthera.2017.01.014. Epub 2017 Jan 30. No abstract available.

PMID:
28153427
10.

Regulatory watch: Innovative drug availability in China.

Shao L, Xu L, Li Q, Chakravarthy R, Yang Z, Kaitin KI.

Nat Rev Drug Discov. 2016 Nov;15(11):739-740. doi: 10.1038/nrd.2016.200. Epub 2016 Oct 21. No abstract available.

PMID:
27765941
11.

The Quest to Develop New Medicines to Treat Alzheimer's Disease: Present Trends and Future Prospects.

Kaitin KI.

Clin Ther. 2015 Aug;37(8):1618-21. doi: 10.1016/j.clinthera.2015.07.004. Epub 2015 Aug 1. No abstract available.

PMID:
26243072
12.

Taking the pulse of strategic outsourcing relationships.

Getz KA, Lamberti MJ, Kaitin KI.

Clin Ther. 2014 Oct 1;36(10):1349-55. doi: 10.1016/j.clinthera.2014.09.008. Epub 2014 Oct 23.

PMID:
25444564
13.

Integrated partnerships and the transformation of pharmaceutical research and development.

Kaitin KI.

Clin Ther. 2014 Oct 1;36(10):1346-8. doi: 10.1016/j.clinthera.2014.09.007. Epub 2014 Oct 6. No abstract available.

PMID:
25301700
14.

The biotechnology innovation machine: a source of intelligent biopharmaceuticals for the pharma industry--mapping biotechnology's success.

Evens RP, Kaitin KI.

Clin Pharmacol Ther. 2014 May;95(5):528-32. doi: 10.1038/clpt.2014.14. Epub 2014 Jan 21.

PMID:
24448474
15.

New Governance Mechanisms to Optimize Protocol Design.

Getz KA, Kim J, Stergiopoulos S, Kaitin KI.

Ther Innov Regul Sci. 2013 Nov;47(6):651-655. doi: 10.1177/2168479013494386.

PMID:
30235547
16.

A proposal for integrated efficacy-to-effectiveness (E2E) clinical trials.

Selker HP, Oye KA, Eichler HG, Stockbridge NL, Mehta CR, Kaitin KI, McElwee NE, Honig PK, Erban JK, D'Agostino RB.

Clin Pharmacol Ther. 2014 Feb;95(2):147-53. doi: 10.1038/clpt.2013.177. Epub 2013 Sep 23.

17.

Reinventing bioinnovation.

Kaitin KI, Honig PK.

Clin Pharmacol Ther. 2013 Sep;94(3):279-83. doi: 10.1038/clpt.2013.129.

PMID:
23963211
18.

Quantifying the magnitude and cost of collecting extraneous protocol data.

Getz KA, Stergiopoulos S, Marlborough M, Whitehill J, Curran M, Kaitin KI.

Am J Ther. 2015 Mar-Apr;22(2):117-24. doi: 10.1097/MJT.0b013e31826fc4aa.

PMID:
23429165
19.

Oncology drug development and approval of systemic anticancer therapy by the U.S. Food and Drug Administration.

Martell RE, Sermer D, Getz K, Kaitin KI.

Oncologist. 2013;18(1):104-11. doi: 10.1634/theoncologist.2012-0235. Epub 2012 Dec 20.

20.

Open innovation: the new face of pharmaceutical research and development.

Getz KA, Kaitin KI.

Expert Rev Clin Pharmacol. 2012 Sep;5(5):481-3. doi: 10.1586/ecp.12.44. No abstract available.

PMID:
23121265
21.

Evaluating the completeness and accuracy of MedWatch data.

Getz KA, Stergiopoulos S, Kaitin KI.

Am J Ther. 2014 Nov-Dec;21(6):442-6. doi: 10.1097/MJT.0b013e318262316f.

PMID:
23011177
22.

Translational research and the evolving landscape for biomedical innovation.

Kaitin KI.

J Investig Med. 2012 Oct;60(7):995-8. doi: 10.2310/JIM.0b013e318268694f. Review.

23.

FDA review divisions: performance levels and the impact on drug sponsors.

Milne CP, Kaitin KI.

Clin Pharmacol Ther. 2012 Mar;91(3):393-404. doi: 10.1038/clpt.2011.338. Epub 2012 Feb 15.

PMID:
22336592
24.

A dearth of new meds.

Kaitin KI, Milne CP.

Sci Am. 2011 Aug;305(2):16. No abstract available.

PMID:
21827111
25.

Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009.

Kaitin KI, DiMasi JA.

Clin Pharmacol Ther. 2011 Feb;89(2):183-8. doi: 10.1038/clpt.2010.286. Epub 2010 Dec 29. Review.

PMID:
21191382
26.

Impact of the new US health-care-reform legislation on the pharmaceutical industry: who are the real winners?

Milne CP, Kaitin KI.

Clin Pharmacol Ther. 2010 Nov;88(5):589-92. doi: 10.1038/clpt.2010.167.

27.

The Landscape for Pharmaceutical Innovation: Drivers of Cost-Effective Clinical Research.

Kaitin KI.

Pharm Outsourcing. 2010 May;2010. pii: 3605. No abstract available.

28.

Translational medicine: an engine of change for bringing new technology to community health.

Milne CP, Kaitin KI.

Sci Transl Med. 2009 Nov 4;1(5):5cm5. doi: 10.1126/scitranslmed.3000222.

PMID:
20368172
29.

Deconstructing the drug development process: the new face of innovation.

Kaitin KI.

Clin Pharmacol Ther. 2010 Mar;87(3):356-61. doi: 10.1038/clpt.2009.293. Epub 2010 Feb 3. Review. No abstract available. Erratum in: Clin Pharmacol Ther. 2011 Jan;89(1):148.

30.

Assessing the impact of protocol design changes on clinical trial performance.

Getz KA, Wenger J, Campo RA, Seguine ES, Kaitin KI.

Am J Ther. 2008 Sep-Oct;15(5):450-7. doi: 10.1097/MJT.0b013e31816b9027.

PMID:
18806521
31.

Obstacles and opportunities in new drug development.

Kaitin KI.

Clin Pharmacol Ther. 2008 Feb;83(2):210-2. doi: 10.1038/sj.clpt.6100462. No abstract available.

PMID:
18202685
32.

Mandatory comparator trials for therapeutically similar drugs: an assessment of the facts.

Milne CP, Kaitin KI, Dimasi JA.

Am J Ther. 2007 May-Jun;14(3):231-4. No abstract available.

PMID:
17515695
33.

Concluding remarks.

Kaitin KI.

Pharmacoeconomics. 2006 Dec;24 Suppl 2:121-2. doi: 10.2165/00019053-200624002-00013. No abstract available.

PMID:
23389495
34.

IN MEMORIUM: Louis C. Lasagna, M.D., 1923-2003 American Journal of Therapeutics.

Kaitin KI.

Am J Ther. 2004 Jan-Feb;11(1):80-1. No abstract available.

PMID:
14704794
35.

Canadian and US drug approval times and safety considerations.

Rawson NS, Kaitin KI.

Ann Pharmacother. 2003 Oct;37(10):1403-8.

PMID:
14519031
36.
37.

Issues facing the new FDA commissioner.

Lasagna L, Kaitin KI.

Science. 1998 Nov 13;282(5392):1263. No abstract available.

38.

The prescription Drug User Fee Act of 1992 and the new drug development process.

Kaitin KI.

Am J Ther. 1997 May-Jun;4(5-6):167-72.

PMID:
10423607
39.

The new drug approvals of 1993, 1994, and 1995: trends in drug development.

Kaitin KI, Manocchia M.

Am J Ther. 1997 Jan;4(1):46-54.

PMID:
10423591
40.

The Prescription Drug User Fee Act of 1992. A 5-year experiment for industry and the FDA.

Shulman SR, Kaitin KI.

Pharmacoeconomics. 1996 Feb;9(2):121-33. Review.

PMID:
10160091
41.

Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: a regulatory perspective.

Bakke OM, Manocchia M, de Abajo F, Kaitin KI, Lasagna L.

Clin Pharmacol Ther. 1995 Jul;58(1):108-17.

PMID:
7628177
42.

The new drug approvals of 1990, 1991, and 1992: trends in drug development.

Kaitin KI, Manocchia M, Seibring M, Lasagna L.

J Clin Pharmacol. 1994 Feb;34(2):120-7.

PMID:
8163711
43.

The role of the research-based pharmaceutical industry in medical progress in the United States.

Kaitin KI, Bryant NR, Lasagna L.

J Clin Pharmacol. 1993 May;33(5):412-7.

PMID:
8331197
44.

Pharmaceutical regulation in the European Community: barriers to single market integration.

Orzack LH, Kaitin KI, Lasagna L.

J Health Polit Policy Law. 1992 Winter;17(4):847-68.

PMID:
1299692
45.

Graft-versus-host disease.

Kaitin KI.

N Engl J Med. 1991 Aug 1;325(5):357-8. No abstract available.

PMID:
2057040
46.

New indications for already-approved drugs: an analysis of regulatory review times.

DiMasi JA, Kaitin KI, Fernandez-Carol C, Lasagna L.

J Clin Pharmacol. 1991 Mar;31(3):205-15.

PMID:
2019661
47.

The new drug approvals of 1987, 1988, and 1989: trends in drug development.

Kaitin KI, DiCerbo PA, Lasagna L.

J Clin Pharmacol. 1991 Feb;31(2):116-22.

PMID:
2010558
48.

Therapeutic ratings and end-of-phase II conferences: initiatives to accelerate the availability of important new drugs.

Kaitin KI, Phelan NR, Raiford D, Morris B.

J Clin Pharmacol. 1991 Jan;31(1):17-24.

PMID:
2045524
49.

Case studies of expedited review: AZT and L-dopa.

Kaitin KI.

Law Med Health Care. 1991 Fall-Winter;19(3-4):242-6. No abstract available.

PMID:
1779693
50.

FDA advisory committees and the new drug approval process.

Kaitin KI, Melville A, Morris B.

J Clin Pharmacol. 1989 Oct;29(10):886-90.

PMID:
2592579

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