Statistics in Medicine

Table of Contents

Volume 19 Issue 20 (30 October 2000)

2719-2897

Prefaces

Preface

  • Author: Shein‐Chung Chow, Jen‐pei Liu
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2719::AID-SIM540>3.0.CO;2-P (p 2719-2719)

Research Articles

A practical approach for evaluating population and individual bioequivalence

  • Author: A. Lawrence Gould
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2721::AID-SIM541>3.0.CO;2-8 (p 2721-2740)

The bootstrap procedure in individual bioequivalence

  • Author: Jun Shao, Shein‐Chung Chow, Bill Wang
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2741::AID-SIM542>3.0.CO;2-3 (p 2741-2754)

On a reasonable disaggregate criterion of population bioequivalence admitting of resampling‐free testing procedures

  • Author: Stefan Wellek
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2755::AID-SIM543>3.0.CO;2-O (p 2755-2767)

The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by a research‐based pharmaceutical company

  • Author: Dieter Hauschke, Volker W. Steinijans
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2769::AID-SIM544>3.0.CO;2-8 (p 2769-2774)

Numerical methods for the evaluation of individual bioequivalence criteria

  • Author: Ebi K. Kimanani, Jean Lavigne, Diane Potvin
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2775::AID-SIM545>3.0.CO;2-G (p 2775-2795)

Definition of individual bioequivalence: occasion‐to‐occasion versus mean switchability

  • Author: Ebi K. Kimanani
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2797::AID-SIM546>3.0.CO;2-5 (p 2797-2810)

Case studies, practical issues and observations on population and individual bioequivalence

  • Author: Névine M.‐D. Zariffa, S. D. Patterson, D. Boyle, M. Hyneck
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2811::AID-SIM547>3.0.CO;2-P (p 2811-2820)

An individual bioequivalence criterion: regulatory considerations

  • Author: Mei‐Ling Chen, Rabindra Patnaik, Walter W. Hauck, Donald J. Schuirmann, Terry Hyslop, Roger Williams
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2821::AID-SIM548>3.0.CO;2-L (p 2821-2842)

Connections between average and individual bioequivalence

  • Author: Axel Munk
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2843::AID-SIM549>3.0.CO;2-A (p 2843-2854)

An alternative index for assessing profile similarity in bioequivalence trials

  • Author: David T. Mauger, Vernon M. Chinchilli
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2855::AID-SIM550>3.0.CO;2-T (p 2855-2866)

Properties of the estimated variance component for subject‐by‐formulation interaction in studies of individual bioequivalence

  • Author: Laszlo Endrenyi, Nathan Taback, Laszlo Tothfalusi
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2867::AID-SIM551>3.0.CO;2-J (p 2867-2878)

Some statistical considerations on the FDA draft guidance for individual bioequivalence

  • Author: Francis C. Hsuan
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2879::AID-SIM552>3.0.CO;2-9 (p 2879-2884)

A small sample confidence interval approach to assess individual bioequivalence

  • Author: Terry Hyslop, Francis Hsuan, Daniel J. Holder
  • Pub Online: Oct 06, 2000
  • DOI: 10.1002/1097-0258(20001030)19:20<2885::AID-SIM553>3.0.CO;2-H (p 2885-2897)

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