Pharmaceutical Statistics

Cover image for Vol. 13 Issue 1

Special Issue: Bayesian Methods in Drug Development and Regulatory Review

January/Febuary 2014

Volume 13, Issue 1

Pages 1–100

Issue edited by: Karen Price, Lisa LaVange

  1. Editorial

    1. Top of page
    2. Editorial
    3. Main Papers
  2. Main Papers

    1. Top of page
    2. Editorial
    3. Main Papers
    1. The current state of Bayesian methods in medical product development: survey results and recommendations from the DIA Bayesian Scientific Working Group (pages 3–12)

      Fanni Natanegara, Beat Neuenschwander, John W. Seaman Jr., Nelson Kinnersley, Cory R. Heilmann, David Ohlssen and George Rochester

      Version of Record online: 11 SEP 2013 | DOI: 10.1002/pst.1595

    2. Bayesian methods for design and analysis of safety trials (pages 13–24)

      Karen L. Price, H. Amy Xia, Mani Lakshminarayanan, David Madigan, David Manner, John Scott, James D. Stamey and Laura Thompson

      Version of Record online: 30 JUL 2013 | DOI: 10.1002/pst.1586

    3. Use of historical control data for assessing treatment effects in clinical trials (pages 41–54)

      Kert Viele, Scott Berry, Beat Neuenschwander, Billy Amzal, Fang Chen, Nathan Enas, Brian Hobbs, Joseph G. Ibrahim, Nelson Kinnersley, Stacy Lindborg, Sandrine Micallef, Satrajit Roychoudhury and Laura Thompson

      Version of Record online: 4 AUG 2013 | DOI: 10.1002/pst.1589

    4. Guidance on the implementation and reporting of a drug safety Bayesian network meta-analysis (pages 55–70)

      David Ohlssen, Karen L. Price, H. Amy Xia, Hwanhee Hong, Jouni Kerman, Haoda Fu, George Quartey, Cory R. Heilmann, Haijun Ma and Bradley P. Carlin

      Version of Record online: 30 AUG 2013 | DOI: 10.1002/pst.1592

    5. A practical guide to Bayesian group sequential designs (pages 71–80)

      Thomas Gsponer, Florian Gerber, Björn Bornkamp, David Ohlssen, Marc Vandemeulebroecke and Heinz Schmidli

      Version of Record online: 24 AUG 2013 | DOI: 10.1002/pst.1593

    6. Bayesian modeling of cost-effectiveness studies with unmeasured confounding: a simulation study (pages 94–100)

      James D. Stamey, Daniel P. Beavers, Douglas Faries, Karen L. Price and John W. Seaman, Jr.

      Version of Record online: 13 NOV 2013 | DOI: 10.1002/pst.1604