Zobrazeno 1 - 10
of 17
pro vyhledávání: '"Jeffrey D. Wetherington"'
Autor:
Gang Li, Kert Viele, Robert B. Noble, Jeffrey D. Wetherington, Linda M. Mundy, Kristine Broglio
Publikováno v:
Pharmaceutical Statistics. 17:811-822
New antimicrobial drugs for treatment of complicated urinary tract infection (cUTI) are generally assessed in randomized, double-blind, noninferiority clinical trials. Robust historical data for the active comparator inform on treatment effect estima
Publikováno v:
Antimicrobial Agents and Chemotherapy, Vol. 59, No 7 (2015) pp. 3695-99
As the number of antibacterial medicines in the pipeline remains low, we anonymously surveyed pharmaceutical industry professionals on challenges and solutions for clinical development of these agents. Challenges were reported primarily as financial
Autor:
Linda M. Mundy, Fanny S Mitrani-Gold, Jeffrey D. Wetherington, Krishan Singh, John F. Tomayko, Gang Li, Milena Kurtinecz
Publikováno v:
Antimicrobial Agents and Chemotherapy. 57:5284-5290
Noninferiority trial design and analyses are commonly used to establish the effectiveness of a new antimicrobial drug for treatment of serious infections such as complicated urinary tract infection (cUTI). A systematic review and meta-analysis were c
Autor:
Jeffrey D. Wetherington, Rajesh Krishna, Sandy Allerheiligen, Julie A. Stone, Christopher Banfield, Marc Pfister, Dennis M. Grasela, Stacey Tannenbaum
Publikováno v:
The Journal of Clinical Pharmacology. 50:20S-30S
During the past decade, the pharmaceutical industry has seen the increasing application of pharmacometrics approaches in drug development. However, the full potential of incorporating model-based approaches in drug development and its impact on decis
Publikováno v:
Trials
A standard two-arm randomised controlled trial usually compares a novel treatment to a standard of care. Patients are randomised 1:1 to each treatment and the analysis is based only on patients within the current trial. While historical data is often
Publikováno v:
Proceedings of the Water Environment Federation. 2005:192-211
Publikováno v:
Journal of the American Statistical Association. 96:835-843
We consider dose response studies for safety assessment of crop protection compounds and drugs, and we offer a hypothesis testing approach for identifying the maximum dose level that is guaranteed to be safe with preassigned confidence. The focus is
Autor:
Aaron Dane, Jeffrey D. Wetherington
Publikováno v:
Pharmaceutical statistics. 13(4)
At present, there are situations in antibiotic drug development where the low number of enrollable patients with key problem pathogens makes it impossible to conduct fully powered non-inferiority trials in the traditional way. Recent regulatory chang
Autor:
Paul G. Richardson, Keith Stockerl-Goldstein, Jeffrey D. Wetherington, Catherine E. Ellis, Larry D. Anderson, Peter M. Voorhees, Nikoletta Lendvai, James Cavet, Yan Degenhardt, Isabelle Pouliquen, Suzanne Trudel, Adam D. Cohen, Joanna Opalinska, Heather J. Sutherland, Rakesh Popat, Edward N. Libby, Fiona Germaschewski
Publikováno v:
Cancer Research. 76:CT034-CT034
Background: Expression of B cell maturation antigen (BCMA), a cell surface receptor belonging to the tumor necrosis factor receptor superfamily, is restricted to B cells at later stages of differentiation and is requisite for the survival of long liv
Autor:
Harvey Thomas Banks, Jeffrey D. Wetherington, Ariel Cintrón-Arias, Kathleen Holm, Grace M. Kepler, Nathan C. Wanner
Publikováno v:
Mathematical and computer modelling. 50(7-8)
We present a preliminary first-pass dynamic model for delivery of drug compounds to the lungs and heart. We use a compartmental mass-balance approach to develop a system of nonlinear differential equations for mass accumulated in the heart as a resul