Mark D Rothmann

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Design and analysis of non-inferiority mortality trials in oncology
    Mark 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
  2. ncbi request reprint On non-inferiority analysis based on delta-method confidence intervals
    Mark D Rothmann
    Division of Biometrics I, OB OPSS CDER, Food and Drug Administration, Rockville, Maryland 20857, USA
    J Biopharm Stat 13:565-83. 2003
  3. ncbi request reprint Type I error probabilities based on design-stage strategies with applications to noninferiority trials
    Mark Rothmann
    Food and Drug Administration, Rockville, Maryland 20857, USA
    J Biopharm Stat 15:109-27. 2005
  4. ncbi request reprint Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia
    Martin 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
  5. ncbi request reprint Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors
    Ramzi Dagher
    Division of Oncology Drug Products, United States Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 8:3034-8. 2002
  6. ncbi request reprint Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase
    John 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

Detail Information

Publications6

  1. ncbi request reprint Design and analysis of non-inferiority mortality trials in oncology
    Mark 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...
  2. ncbi request reprint On non-inferiority analysis based on delta-method confidence intervals
    Mark 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...
  3. ncbi request reprint Type I error probabilities based on design-stage strategies with applications to noninferiority trials
    Mark 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...
  4. ncbi request reprint Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia
    Martin 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...
  5. ncbi request reprint Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors
    Ramzi Dagher
    Division of Oncology Drug Products, United States Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 8:3034-8. 2002
    ....
  6. ncbi request reprint Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase
    John 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
    ....