Mark D Rothmann
Affiliation: Food and Drug Administration
- Design and analysis of non-inferiority mortality trials in oncologyMark Rothmann
Division of Biometrics I, OB OPaSS CDER, Food and Drug Administration, HFD 710, WOCII 5600 Fishers Lane, Rockville, MD 20857, USA
Stat Med 22:239-64. 2003..Other methodologies are also described and assessed - including a point estimate procedure, a Bayesian procedure and two delta-method confidence interval procedures. Published in 2003 by John Wiley & Sons, Ltd...
- On non-inferiority analysis based on delta-method confidence intervalsMark D Rothmann
Division of Biometrics I, OB OPSS CDER, Food and Drug Administration, Rockville, Maryland 20857, USA
J Biopharm Stat 13:565-83. 2003..The delta-method 95% confidence interval procedures will also be contrasted with Fieller 95% confidence intervals. Testing based on Fieller 95% confidence intervals will maintain a desired approximate type I error rate...
- Type I error probabilities based on design-stage strategies with applications to noninferiority trialsMark Rothmann
Food and Drug Administration, Rockville, Maryland 20857, USA
J Biopharm Stat 15:109-27. 2005..Results are applied to the setting of noninferiority comparisons in active controlled trials where the use of a placebo is unethical...
- Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemiaMartin H Cohen
Division Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 8:935-42. 2002..In this report, we describe the preclinical profile of imatinib and the data submitted in the New Drug Application that led to its marketing approval...
- Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumorsRamzi Dagher
Division of Oncology Drug Products, United States Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 8:3034-8. 2002....
- Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myelogenous leukemia in chronic phaseJohn R Johnson
Division of Oncology Drug Products HFD 150, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Cancer Res 9:1972-9. 2003....