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Statistical Approaches to Establishing Bioequivalence

Statistical Approaches to Establishing Bioequivalence

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This guidance provides recommendations to sponsors and applicants who intend, either before or after approval, to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and supplements to these applications. This guidance discusses three approaches for BE comparisons: average, population, and individual. The guidance focuses on how to use each approach once a specific approach has been chosen. This guidance replaces a prior FDA guidance entitled Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design, which was issued in July 1992.
This guidance provides recommendations to sponsors and applicants who intend, either before or after approval, to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and supplements to these applications. This guidance discusses three approaches for BE comparisons: average, population, and individual. The guidance focuses on how to use each approach once a specific approach has been chosen. This guidance replaces a prior FDA guidance entitled Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design, which was issued in July 1992.

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Published by: Ahmad Abdullah Najjar on Jul 29, 2008
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10/17/2011

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Guidance for Industry
Statistical Approaches toEstablishing Bioequivalence
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)January 2001BP
 
Guidance for Industry
Statistical Approaches toEstablishing Bioequivalence
 Additional copies are available from:Office of Training and Communications Division of Communications Management  Drug Information Branch, HFD-2105600 Fishers Lane Rockville MD 20857 (Tel) 301-827-4573(Internet)
 
http://www.fda.gov/cder/guidance/index.htm
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)January 2001BP
 
Table of Contents
I.INTRODUCTION..................................................................................................................................................................1II.BACKGROUND....................................................................................................................................................................1
A.G
ENERAL
.............................................................................................................................................................................1B.S
TATISTICAL
......................................................................................................................................................................2
III.STATISTICAL MODEL......................................................................................................................................................3IV.STATISTICAL APPROACHES FOR BIOEQUIVALENCE.........................................................................................3
A.A
VERAGE
B
IOEQUIVALENCE
..............................................................................................................................................4B.P
OPULATION
B
IOEQUIVALENCE
.........................................................................................................................................5C.I
NDIVIDUAL
B
IOEQUIVALENCE
...........................................................................................................................................6
V.STUDY DESIGN....................................................................................................................................................................7
A.E
XPERIMENTAL
D
ESIGN
.....................................................................................................................................................7B.S
AMPLE
S
IZE AND
D
ROPOUTS
...........................................................................................................................................8
VI.STATISTICAL ANALYSIS................................................................................................................................................9
A.L
OGARITHMIC
T
RANSFORMATION
....................................................................................................................................9B.D
ATA
A
NALYSIS
..............................................................................................................................................................10
VII.MISCELLANEOUS ISSUES........................................................................................................................................13
A.S
TUDIES IN
M
ULTIPLE
G
ROUPS
.......................................................................................................................................13B.C
ARRYOVER
E
FFECTS
......................................................................................................................................................13C.O
UTLIER
C
ONSIDERATIONS
.............................................................................................................................................14D.D
ISCONTINUITY
................................................................................................................................................................15
REFERENCES................................................................................................................................................................................16APPENDIX A..................................................................................................................................................................................21APPENDIX B..................................................................................................................................................................................25APPENDIX C..................................................................................................................................................................................28APPENDIX D..................................................................................................................................................................................32APPENDIX E..................................................................................................................................................................................34APPENDIX F..................................................................................................................................................................................35APPENDIX G..................................................................................................................................................................................40APPENDIX H..................................................................................................................................................................................45

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