Statistics in Medicine

Cover image for Vol. 32 Issue 3

Special Issue: Assessing Biosimilarity and Interchangeability of Biosimilar Products

10 February 2013

Volume 32, Issue 3

Pages 361–537

Issue edited by: Shein-Chung Chow

  1. Preface

    1. Top of page
    2. Preface
    3. Special Issue Papers
    4. Research Articles
  2. Special Issue Papers

    1. Top of page
    2. Preface
    3. Special Issue Papers
    4. Research Articles
    1. Comments on the FDA draft guidance on biosimilar products (pages 364–369)

      Shein-Chung Chow, Laszlo Endrenyi and Peter A. Lachenbruch

      Article first published online: 18 AUG 2012 | DOI: 10.1002/sim.5572

    2. Scientific considerations for assessing biosimilar products (pages 370–381)

      Shein-Chung Chow, Jun Wang, Laszlo Endrenyi and Peter A. Lachenbruch

      Article first published online: 30 AUG 2012 | DOI: 10.1002/sim.5571

    3. Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics (pages 424–433)

      Nan Zhang, Jun Yang, Shein-Chung Chow, Laszlo Endrenyi and Eric Chi

      Article first published online: 30 AUG 2012 | DOI: 10.1002/sim.5567

    4. On the interchangeability of biologic drug products (pages 434–441)

      Laszlo Endrenyi, Chiann Chang, Shein-Chung Chow and Laszlo Tothfalusi

      Article first published online: 22 AUG 2012 | DOI: 10.1002/sim.5569

    5. Statistical methods for assessing interchangeability of biosimilars (pages 442–448)

      Shein-Chung Chow, Lan-Yan Yang, Aijing Starr and Shih-Ting Chiu

      Article first published online: 17 AUG 2012 | DOI: 10.1002/sim.5566

      Corrected by:

      Correction: Correction

      Vol. 32, Issue 18, 3234, Article first published online: 24 JAN 2013

    6. Application of the parallel line assay to assessment of biosimilar products based on binary endpoints (pages 449–461)

      Jr-Rung Lin, Shein-Chung Chow, Chih-Hsi Chang, Ya-Ching Lin and Jen-pei Liu

      Article first published online: 22 AUG 2012 | DOI: 10.1002/sim.5565

  3. Research Articles

    1. Top of page
    2. Preface
    3. Special Issue Papers
    4. Research Articles
    1. Adaptive linear rank tests for eQTL studies (pages 524–537)

      Silke Szymczak, Markus O. Scheinhardt, Tanja Zeller, Philipp S. Wild, Stefan Blankenberg and Andreas Ziegler

      Article first published online: 30 AUG 2012 | DOI: 10.1002/sim.5593

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