Pinheiro J - Search Results

1

Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop.

Krams M, Burman CF, Dragalin V, Gaydos B, Grieve AP, Pinheiro J, Maurer W, Gallo P. Krams M, et al. Among authors: pinheiro j. J Biopharm Stat. 2007;17(6):957-64. doi: 10.1080/10543400701643764. J Biopharm Stat. 2007. PMID: 18027207

2

Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group.

Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J; PhRMA Working Group. Gallo P, et al. Among authors: pinheiro j. J Biopharm Stat. 2006 May;16(3):275-83; discussion 285-91, 293-8, 311-2. doi: 10.1080/10543400600614742. J Biopharm Stat. 2006. PMID: 16724485

3

Innovative approaches for designing and analyzing adaptive dose-ranging trials.

Bornkamp B, Bretz F, Dmitrienko A, Enas G, Gaydos B, Hsu CH, König F, Krams M, Liu Q, Neuenschwander B, Parke T, Pinheiro J, Roy A, Sax R, Shen F. Bornkamp B, et al. Among authors: pinheiro j. J Biopharm Stat. 2007;17(6):965-95. doi: 10.1080/10543400701643848. J Biopharm Stat. 2007. PMID: 18027208

4

Viewpoints on the FDA draft adaptive designs guidance from the PhRMA working group.

Gallo P, Anderson K, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J. Gallo P, et al. Among authors: pinheiro j. J Biopharm Stat. 2010 Nov;20(6):1115-24. doi: 10.1080/10543406.2010.514452. J Biopharm Stat. 2010. PMID: 21058107

5

The future of drug development: advancing clinical trial design.

Orloff J, Douglas F, Pinheiro J, Levinson S, Branson M, Chaturvedi P, Ette E, Gallo P, Hirsch G, Mehta C, Patel N, Sabir S, Springs S, Stanski D, Evers MR, Fleming E, Singh N, Tramontin T, Golub H. Orloff J, et al. Among authors: pinheiro j. Nat Rev Drug Discov. 2009 Dec;8(12):949-57. doi: 10.1038/nrd3025. Epub 2009 Oct 9. Nat Rev Drug Discov. 2009. PMID: 19816458 Review.

6

Optimizing Drug Development Programs: Type 2 Diabetes Case Study.

Antonijevic Z, Kimber M, Manner D, Burman CF, Pinheiro J, Bergenheim K. Antonijevic Z, et al. Among authors: pinheiro j. Ther Innov Regul Sci. 2013 May;47(3):363-374. doi: 10.1177/2168479013480501. Ther Innov Regul Sci. 2013. PMID: 30231431

7

Practical considerations for optimal designs in clinical dose finding studies.

Bretz F, Dette H, Pinheiro JC. Bretz F, et al. Stat Med. 2010 Mar 30;29(7-8):731-42. doi: 10.1002/sim.3802. Stat Med. 2010. PMID: 20213708 Free PMC article.

8

Design and analysis of dose-finding studies combining multiple comparisons and modeling procedures.

Pinheiro J, Bornkamp B, Bretz F. Pinheiro J, et al. J Biopharm Stat. 2006;16(5):639-56. doi: 10.1080/10543400600860428. J Biopharm Stat. 2006. PMID: 17037263

9

Designing multiregional trials under the discrete random effects model.

Lan KK, Pinheiro J, Chen F. Lan KK, et al. Among authors: pinheiro j. J Biopharm Stat. 2014;24(2):415-28. doi: 10.1080/10543406.2013.860155. J Biopharm Stat. 2014. PMID: 24605977

10

Model-based dose finding under model uncertainty using general parametric models.

Pinheiro J, Bornkamp B, Glimm E, Bretz F. Pinheiro J, et al. Stat Med. 2014 May 10;33(10):1646-61. doi: 10.1002/sim.6052. Epub 2013 Dec 3. Stat Med. 2014. PMID: 24302486

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