Gaydos B - Search Results

1

Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study.

Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Spencer K, et al. Among authors: gaydos b. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608. J Diabetes Sci Technol. 2012. PMID: 23294774 Free PMC article. Clinical Trial.

2

Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5).

Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Skrivanek Z, et al. Among authors: gaydos bl. Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22. Diabetes Obes Metab. 2014. PMID: 24762094 Free article. Clinical Trial.

3

Application of adaptive design methodology in development of a long-acting glucagon-like peptide-1 analog (dulaglutide): statistical design and simulations.

Skrivanek Z, Berry S, Berry D, Chien J, Geiger MJ, Anderson JH, Gaydos B. Skrivanek Z, et al. Among authors: gaydos b. J Diabetes Sci Technol. 2012 Nov 1;6(6):1305-18. doi: 10.1177/193229681200600609. J Diabetes Sci Technol. 2012. PMID: 23294775 Free PMC article. Clinical Trial.

4

An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): trial design and baseline characteristics.

Geiger MJ, Skrivanek Z, Gaydos B, Chien J, Berry S, Berry D. Geiger MJ, et al. Among authors: gaydos b. J Diabetes Sci Technol. 2012 Nov 1;6(6):1319-27. doi: 10.1177/193229681200600610. J Diabetes Sci Technol. 2012. PMID: 23294776 Free PMC article. Clinical Trial.

5

Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes.

Geiger MJ, Mehta C, Turner JR, Arbet-Engels C, Hantel S, Hirshberg B, Koglin J, Mendzelevski B, Sager PT, Shapiro D, Stewart M, Todaro TG, Gaydos B. Geiger MJ, et al. Among authors: gaydos b. Ther Innov Regul Sci. 2015 Jan;49(1):50-64. doi: 10.1177/2168479014549860. Ther Innov Regul Sci. 2015. PMID: 30222452

6

A clinical utility index for selecting an optimal insulin dosing algorithm for LY2605541 in patients with type 2 diabetes pretreated with basal insulin.

Manner DH, Luo J, Qu Y, Berry S, Gaydos BL, Jacober SJ. Manner DH, et al. Among authors: gaydos bl. Diabetes Technol Ther. 2014 Aug;16(8):499-505. doi: 10.1089/dia.2013.0268. Epub 2014 May 13. Diabetes Technol Ther. 2014. PMID: 24825416 Clinical Trial.

7

Perspectives on Some Controversies in Cardiovascular Disease Risk Assessment in the Pharmaceutical Development of Glucose-Lowering Medications.

Hoogwerf BJ, Manner DH, Fu H, Moscarelli E, Gaydos BL, Heine RJ. Hoogwerf BJ, et al. Among authors: gaydos bl. Diabetes Care. 2016 Aug;39 Suppl 2:S219-27. doi: 10.2337/dcS15-3025. Diabetes Care. 2016. PMID: 27440836 Review.

8

Adaptive Design: Results of 2012 Survey on Perception and Use.

Morgan CC, Huyck S, Jenkins M, Chen L, Bedding A, Coffey CS, Gaydos B, Wathen JK. Morgan CC, et al. Among authors: gaydos b. Ther Innov Regul Sci. 2014 Jul;48(4):473-481. doi: 10.1177/2168479014522468. Ther Innov Regul Sci. 2014. PMID: 30235570

9

Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development.

Quinlan J, Gaydos B, Maca J, Krams M. Quinlan J, et al. Among authors: gaydos b. Clin Trials. 2010 Apr;7(2):167-73. doi: 10.1177/1740774510361542. Epub 2010 Mar 25. Clin Trials. 2010. PMID: 20338900

10

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: gaydos b. 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

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