Zobrazeno 1 - 10 of 19 pro vyhledávání: '"Susan P. Duke"'
1
Statistical Practices of Safety Monitoring: An Industry Survey
Autor: Faiz Ahmad, Greg Ball, William Wang, Robert Gordon, Susan P. Duke, Michael W. Colopy
Publikováno v: Therapeutic Innovation & Regulatory Science. 53:293-300
The Biopharmaceutical Section of the American Statistical Association (ASA) formed a Safety Monitoring Working Group to strengthen collaborations between biostatisticians and safety scientists. The task began by surveying current needs and practices
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::407a3fed176b71f3787672a3d209bed1
https://doi.org/10.1177/2168479018779973
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2
Quantitative Methods for Safety Monitoring of Rare Serious Adverse Events
Autor: Susan P. Duke, Eric Lewis, Deanna D. Hill, Dimitri Bennett, Christi S. Kleoudis, Margaret Polinkovsky
Publikováno v: Pharmaceutical Medicine. 31:113-118
Rare but serious adverse events are often reasons for the modification of drug product labelling, termination of further development and even withdrawal of a treatment from the market. Our objective was to use analytical methods to evaluate adverse e
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a8eb7d3a7ad8144c4e9cf996abdb4ad8
https://doi.org/10.1007/s40290-016-0176-0
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3
Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions
Autor: Amit Bhattacharyya, Mengchun Li, Susan P. Duke, Jonathan Seltzer, Faiz Ahmad, Greg Ball, Lothar Tremmel, Judith Weigel, James M. Buchanan, Qi Jiang, William Wang, Esteban Herrero-Martinez, Wenquan Wang, Raffael Kurek, Barbara A Hendrickson, Dennis O’Brien
Publikováno v: Therapeutic Innovation & Regulatory Science
Notwithstanding successful harmonization efforts, the global regulatory framework governing product safety is complex and continually evolving, as evidenced by additional regional guidance and regulations. In this regulatory review, we provide an ove
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d35ea6e71438c6b7a4210b9ec4742e20
https://pubmed.ncbi.nlm.nih.gov/32072595
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4
Statistical Computing Environments and the Practice of Statistics in the Biopharmaceutical Industry
Autor: Susan P. Duke, Sue Dubman, Alan Hopkins
Publikováno v: Drug Information Journal. 44:29-42
A structured statistical computing environment (SCE) enhances rigor in operational implementation of statistical analyses of clinical studies through process transparency, allowing reproducibility of results by independent reviewers. Desirable featur
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::b00b69b0f51515a6708d24bf846328f7
https://doi.org/10.1177/009286151004400104
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5
Potential Effects of Fluticasone Propionate on Bone Mineral Density in Patients With Asthma: A 2-Year Randomized, Double-Blind, Placebo-Controlled Trial
Autor: Scott Osur, Stuart M. Harding, Kenneth G. Faulkner, Susan P. Duke, James P. Kemp, Courtney Crim, Nancy Herje, Stephen Shrewsbury
Publikováno v: Mayo Clinic Proceedings. 79:458-466
Objective To evaluate the effects of treatment with fluticasone propionate vs placebo on bone, hypothalamic-pituitary-adrenal (HPA) axis function, and the eyes in patients with asthma. Patients and Methods This randomized, double-blind, placebo-contr
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::22542a468d5fbd84c2199fd732a9dbab
https://doi.org/10.4065/79.4.458
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6
Long-term Efficacy and Safety of Fluticasone Propionate Powder Administered Once or Twice Daily via Inhaler to Patients With Moderate Asthma
Autor: Jeffery Adelglass, Patrick D. Wire, Richard ZuWallack, Dennis P. Clifford, Stuart M. Harding, Melissa A. Faris, Susan P. Duke
Publikováno v: Chest. 118:303-312
Objective To evaluate the efficacy and safety of fluticasone propionate administered as a once-daily or twice-daily regimen over a period of 1 year to patients with moderate asthma. Design Double-blind, randomized, parallel group, and placebo-control
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::7d7d15a42bf2591208f0bf2b3833f1dd
https://doi.org/10.1378/chest.118.2.303
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7
Design and Analysis of Studies to Assess the Effect of Inhaled Corticosteroids on Growth
Autor: Susan P. Duke, Patrick Darken, Sara H. Hughes, Colin Reisner
Publikováno v: Drug Information Journal. 34:397-409
Assessment of child growth is problematic: growth is nonlinear in the long-term, and unpredictable in the short-term; growth is subject to a number of environmental as well as genetic influences; and growth is difficult to measure reliably. The poten
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::fb9a3fad05ad2955a4363116d6e42942
https://doi.org/10.1177/009286150003400208
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9
Equivalence in Periodontal Trials: A Description for the Clinician
Autor: Steven Garrett, Susan P. Duke
Publikováno v: Journal of Periodontology. 69:650-654
There has been a tendency by clinicians in periodontal research to confuse lack of significance in a clinical trial designed for superiority for equivalence between the treatment arms. This paper is intended to define for the clinician what equivalen
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a8c8ccb7c3d54653698e8a7836a5079f
https://doi.org/10.1902/jop.1998.69.6.650
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10
Use of a Trinomial Distribution Probability Model in Development of a Tier-Testing Scheme for Content Uniformity Testing
Autor: Wayne V. Lam, Charles Panaccione, Richard L. Norton, Susan P. Duke, Amy L. Taylor
Publikováno v: Drug Information Journal. 31:903-909
A trinomial distribution probability model was used to determine the rejection probabilities of various proposed tier-testing schemes for drug content uniformity testing of a unique drug product. The use of this probability model helped in defining a
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::bfe039226d1a8514350d26ac54860ee1
https://doi.org/10.1177/009286159703100334
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