Ohidul Siddiqui

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets
    Ohidul Siddiqui
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 19:227-46. 2009
  2. pmc Endpoints and analyses to discern disease-modifying drug effects in early Parkinson's disease
    Venkatesh Atul Bhattaram
    Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    AAPS J 11:456-64. 2009
  3. doi request reprint MMRM versus MI in dealing with missing data--a comparison based on 25 NDA data sets
    Ohidul Siddiqui
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 21:423-36. 2011
  4. doi request reprint Statistical methods to analyze adverse events data of randomized clinical trials
    Ohidul Siddiqui
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 19:889-99. 2009
  5. doi request reprint Method of balanced adjustment in testing co-primary endpoints
    George Kordzakhia
    Division of Biometrics I, Office of Biostatistics, CDER, FDA, Silver Spring, MD 20993, USA
    Stat Med 29:2055-66. 2010

Collaborators

Detail Information

Publications5

  1. doi request reprint MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets
    Ohidul Siddiqui
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 19:227-46. 2009
    ..In the exploratory analyses of the datasets, no clear evidence of the presence of MNAR missingness is found...
  2. pmc Endpoints and analyses to discern disease-modifying drug effects in early Parkinson's disease
    Venkatesh Atul Bhattaram
    Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    AAPS J 11:456-64. 2009
    ..The outcome of this work is part of the ongoing discussion between the US FDA and the pharmaceutical industry on the standards required for demonstrating disease-modifying effect using delayed start design...
  3. doi request reprint MMRM versus MI in dealing with missing data--a comparison based on 25 NDA data sets
    Ohidul Siddiqui
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 21:423-36. 2011
    ..The MMRM approach appears to be a better choice in maintaining statistical properties of a test as compared to the MI approach in dealing with ignorable missing data of clinical trials...
  4. doi request reprint Statistical methods to analyze adverse events data of randomized clinical trials
    Ohidul Siddiqui
    Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Biopharm Stat 19:889-99. 2009
    ..As compared to the crude or exposure-adjusted incidence rates of adverse events, the MCF estimates facilitate more understanding of safety profiles of a drug in a randomized clinical trial...
  5. doi request reprint Method of balanced adjustment in testing co-primary endpoints
    George Kordzakhia
    Division of Biometrics I, Office of Biostatistics, CDER, FDA, Silver Spring, MD 20993, USA
    Stat Med 29:2055-66. 2010
    ..The method is applicable for the scenario where the null space is restricted. Our testing approach controls maximum joint false positive rate over the restricted null space...