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Pharmacokinetics of the NS3 Protease Inhibitor, Asunaprevir (ASV, BMS-650032), in Phase I Studies in Subjects With or Without Chronic Hepatitis C.

Clinical pharmacology in drug development

Eley T, He B, Huang SP, Li W, Pasquinelli C, Rodrigues AD, Grasela DM, Bertz RJ.
PMID: 27121936
Clin Pharmacol Drug Dev. 2013 Oct;2(4):316-27. doi: 10.1002/cpdd.52. Epub 2013 Aug 16.

Asunaprevir (BMS-650032, ASV) is a potent, selective hepatitis C virus (HCV) NS3 protease inhibitor in clinical evaluation for chronic hepatitis C treatment. ASV pharmacokinetics were evaluated in four single- and multiple-ascending-dose studies in healthy subjects or subjects with HCV...

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Eley T, He B, Huang SP, et al. Pharmacokinetics of the NS3 Protease Inhibitor, Asunaprevir (ASV, BMS-650032), in Phase I Studies in Subjects With or Without Chronic Hepatitis C. Clin Pharmacol Drug Dev. 2013;2(4):316-27doi: 10.1002/cpdd.52.
Eley, T., He, B., Huang, S. P., Li, W., Pasquinelli, C., Rodrigues, A. D., Grasela, D. M., & Bertz, R. J. (2013). Pharmacokinetics of the NS3 Protease Inhibitor, Asunaprevir (ASV, BMS-650032), in Phase I Studies in Subjects With or Without Chronic Hepatitis C. Clinical pharmacology in drug development, 2(4), 316-27. https://doi.org/10.1002/cpdd.52
Eley, Timothy, et al. "Pharmacokinetics of the NS3 Protease Inhibitor, Asunaprevir (ASV, BMS-650032), in Phase I Studies in Subjects With or Without Chronic Hepatitis C." Clinical pharmacology in drug development vol. 2,4 (2013): 316-27. doi: https://doi.org/10.1002/cpdd.52
Eley T, He B, Huang SP, Li W, Pasquinelli C, Rodrigues AD, Grasela DM, Bertz RJ. Pharmacokinetics of the NS3 Protease Inhibitor, Asunaprevir (ASV, BMS-650032), in Phase I Studies in Subjects With or Without Chronic Hepatitis C. Clin Pharmacol Drug Dev. 2013 Oct;2(4):316-27. doi: 10.1002/cpdd.52. Epub 2013 Aug 16. PMID: 27121936.
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Retrospective Analysis Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation Offers Improvements in Efficiency of the Design of Volunteer Infection Studies for Antimalarial Drug Development.

Clinical and translational science

Andrews KA, Owen JS, McCarthy J, Wesche D, Gobeau N, Grasela TH, Möhrle JJ.
PMID: 33326705
Clin Transl Sci. 2021 Mar;14(2):712-719. doi: 10.1111/cts.12934. Epub 2020 Dec 16.

Volunteer infection studies using the induced blood stage malaria (IBSM) model have been shown to facilitate antimalarial drug development. Such studies have traditionally been undertaken in single-dose cohorts, as many as necessary to obtain the dose-response relationship. To enhance...

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Andrews KA, Owen JS, McCarthy J, et al. Retrospective Analysis Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation Offers Improvements in Efficiency of the Design of Volunteer Infection Studies for Antimalarial Drug Development. Clin Transl Sci. 2020;14(2):712-719doi: 10.1111/cts.12934.
Andrews, K. A., Owen, J. S., McCarthy, J., Wesche, D., Gobeau, N., Grasela, T. H., & Möhrle, J. J. (2021). Retrospective Analysis Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation Offers Improvements in Efficiency of the Design of Volunteer Infection Studies for Antimalarial Drug Development. Clinical and translational science, 14(2), 712-719. https://doi.org/10.1111/cts.12934
Andrews, Kayla Ann, et al. "Retrospective Analysis Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation Offers Improvements in Efficiency of the Design of Volunteer Infection Studies for Antimalarial Drug Development." Clinical and translational science vol. 14,2 (2021): 712-719. doi: https://doi.org/10.1111/cts.12934
Andrews KA, Owen JS, McCarthy J, Wesche D, Gobeau N, Grasela TH, Möhrle JJ. Retrospective Analysis Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation Offers Improvements in Efficiency of the Design of Volunteer Infection Studies for Antimalarial Drug Development. Clin Transl Sci. 2021 Mar;14(2):712-719. doi: 10.1111/cts.12934. Epub 2020 Dec 16. PMID: 33326705; PMCID: PMC7993277.
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Implementation of a nursing home urinary incontinence management program with and without tolterodine.

Journal of the American Medical Directors Association

Ouslander JG, Maloney C, Grasela TH, Rogers L, Walawander CA.
PMID: 12812542
J Am Med Dir Assoc. 2001 Sep-Oct;2(5):207-14.

OBJECTIVE: To evaluate the implementation of a nursing home urinary incontinence management program.DESIGN: A prospective field trial of the program incorporating practice guidelines and principles of continuous quality improvement.SETTING: Five nursing homes in New York, Virginia, and GeorgiaPARTICIPANTS: One...

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Ouslander JG, Maloney C, Grasela TH, et al. Implementation of a nursing home urinary incontinence management program with and without tolterodine. J Am Med Dir Assoc. 2001;2(5):207-14
Ouslander, J. G., Maloney, C., Grasela, T. H., Rogers, L., & Walawander, C. A. (2001). Implementation of a nursing home urinary incontinence management program with and without tolterodine. Journal of the American Medical Directors Association, 2(5), 207-14.
Ouslander, J G, et al. "Implementation of a nursing home urinary incontinence management program with and without tolterodine." Journal of the American Medical Directors Association vol. 2,5 (2001): 207-14.
Ouslander JG, Maloney C, Grasela TH, Rogers L, Walawander CA. Implementation of a nursing home urinary incontinence management program with and without tolterodine. J Am Med Dir Assoc. 2001 Sep-Oct;2(5):207-14. PMID: 12812542.
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The paradox of scientific excellence and the search for productivity in pharmaceutical research and development.

Clinical pharmacology and therapeutics

Grasela TH, Slusser R.
PMID: 24458012
Clin Pharmacol Ther. 2014 May;95(5):521-7. doi: 10.1038/clpt.2013.242. Epub 2014 Jan 23.

Scientific advances in specialty areas are proceeding at a rapid rate, but the research and development enterprise seems unable to take full advantage. Harnessing the steady stream of knowledge and inventions from different disciplines is the critical management issue...

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Grasela TH, Slusser R. The paradox of scientific excellence and the search for productivity in pharmaceutical research and development. Clin Pharmacol Ther. 2014;95(5):521-7doi: 10.1038/clpt.2013.242.
Grasela, T. H., & Slusser, R. (2014). The paradox of scientific excellence and the search for productivity in pharmaceutical research and development. Clinical pharmacology and therapeutics, 95(5), 521-7. https://doi.org/10.1038/clpt.2013.242
Grasela, T H, and Slusser, R. "The paradox of scientific excellence and the search for productivity in pharmaceutical research and development." Clinical pharmacology and therapeutics vol. 95,5 (2014): 521-7. doi: https://doi.org/10.1038/clpt.2013.242
Grasela TH, Slusser R. The paradox of scientific excellence and the search for productivity in pharmaceutical research and development. Clin Pharmacol Ther. 2014 May;95(5):521-7. doi: 10.1038/clpt.2013.242. Epub 2014 Jan 23. PMID: 24458012.
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