Two-stage designs for cross-over bioequivalence trials

The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of ada...
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Autor*in:	Kieser, Meinhard [verfasserIn] Rauch, Geraldine [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	24 March 2015

Schlagwörter:	adaptive design bioequivalence cross-over design sample size recalculation two-stage design

Anmerkung:	Gesehen am 01.07.2020
Umfang:	14

Übergeordnetes Werk:	Enthalten in: Statistics in medicine - Chichester [u.a.] : Wiley, 1982, 34(2015), 16, Seite 2403-2416
Übergeordnetes Werk:	volume:34 ; year:2015 ; number:16 ; pages:2403-2416 ; extent:14

Links:	Volltext Volltext

DOI / URN:	10.1002/sim.6487

Katalog-ID:	1703023420

Internformat


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520			\|a The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non-inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid-course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd.
650		4	\|a adaptive design
650		4	\|a bioequivalence
650		4	\|a cross-over design
650		4	\|a sample size recalculation
650		4	\|a two-stage design
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912			\|a GBV_ILN_20
912			\|a GBV_ILN_22
912			\|a GBV_ILN_23
912			\|a GBV_ILN_24
912			\|a GBV_ILN_31
912			\|a GBV_ILN_32
912			\|a GBV_ILN_39
912			\|a GBV_ILN_40
912			\|a GBV_ILN_60
912			\|a GBV_ILN_62
912			\|a GBV_ILN_63
912			\|a GBV_ILN_65
912			\|a GBV_ILN_69
912			\|a GBV_ILN_70
912			\|a GBV_ILN_73
912			\|a GBV_ILN_74
912			\|a GBV_ILN_90
912			\|a GBV_ILN_95
912			\|a GBV_ILN_100
912			\|a GBV_ILN_101
912			\|a GBV_ILN_105
912			\|a GBV_ILN_110
912			\|a GBV_ILN_120
912			\|a GBV_ILN_138
912			\|a GBV_ILN_150
912			\|a GBV_ILN_151
912			\|a GBV_ILN_161
912			\|a GBV_ILN_170
912			\|a GBV_ILN_171
912			\|a GBV_ILN_187
912			\|a GBV_ILN_213
912			\|a GBV_ILN_224
912			\|a GBV_ILN_230
912			\|a GBV_ILN_252
912			\|a GBV_ILN_266
912			\|a GBV_ILN_285
912			\|a GBV_ILN_293
912			\|a GBV_ILN_370
912			\|a GBV_ILN_602
912			\|a GBV_ILN_636
912			\|a GBV_ILN_647
912			\|a GBV_ILN_702
912			\|a GBV_ILN_2001
912			\|a GBV_ILN_2003
912			\|a GBV_ILN_2004
912			\|a GBV_ILN_2005
912			\|a GBV_ILN_2006
912			\|a GBV_ILN_2007
912			\|a GBV_ILN_2008
912			\|a GBV_ILN_2009
912			\|a GBV_ILN_2010
912			\|a GBV_ILN_2011
912			\|a GBV_ILN_2014
912			\|a GBV_ILN_2015
912			\|a GBV_ILN_2018
912			\|a GBV_ILN_2020
912			\|a GBV_ILN_2021
912			\|a GBV_ILN_2025
912			\|a GBV_ILN_2026
912			\|a GBV_ILN_2027
912			\|a GBV_ILN_2031
912			\|a GBV_ILN_2034
912			\|a GBV_ILN_2037
912			\|a GBV_ILN_2038
912			\|a GBV_ILN_2039
912			\|a GBV_ILN_2044
912			\|a GBV_ILN_2048
912			\|a GBV_ILN_2049
912			\|a GBV_ILN_2050
912			\|a GBV_ILN_2055
912			\|a GBV_ILN_2056
912			\|a GBV_ILN_2057
912			\|a GBV_ILN_2059
912			\|a GBV_ILN_2061
912			\|a GBV_ILN_2064
912			\|a GBV_ILN_2068
912			\|a GBV_ILN_2088
912			\|a GBV_ILN_2093
912			\|a GBV_ILN_2106
912			\|a GBV_ILN_2108
912			\|a GBV_ILN_2110
912			\|a GBV_ILN_2111
912			\|a GBV_ILN_2112
912			\|a GBV_ILN_2113
912			\|a GBV_ILN_2118
912			\|a GBV_ILN_2119
912			\|a GBV_ILN_2122
912			\|a GBV_ILN_2129
912			\|a GBV_ILN_2143
912			\|a GBV_ILN_2144
912			\|a GBV_ILN_2147
912			\|a GBV_ILN_2148
912			\|a GBV_ILN_2152
912			\|a GBV_ILN_2153
912			\|a GBV_ILN_2188
912			\|a GBV_ILN_2190
912			\|a GBV_ILN_2232
912			\|a GBV_ILN_2336
912			\|a GBV_ILN_2470
912			\|a GBV_ILN_2472
912			\|a GBV_ILN_2507
912			\|a GBV_ILN_2522
912			\|a GBV_ILN_2548
912			\|a GBV_ILN_4012
912			\|a GBV_ILN_4035
912			\|a GBV_ILN_4037
912			\|a GBV_ILN_4046
912			\|a GBV_ILN_4112
912			\|a GBV_ILN_4125
912			\|a GBV_ILN_4126
912			\|a GBV_ILN_4242
912			\|a GBV_ILN_4246
912			\|a GBV_ILN_4249
912			\|a GBV_ILN_4251
912			\|a GBV_ILN_4305
912			\|a GBV_ILN_4306
912			\|a GBV_ILN_4307
912			\|a GBV_ILN_4313
912			\|a GBV_ILN_4322
912			\|a GBV_ILN_4323
912			\|a GBV_ILN_4324
912			\|a GBV_ILN_4325
912			\|a GBV_ILN_4326
912			\|a GBV_ILN_4333
912			\|a GBV_ILN_4334
912			\|a GBV_ILN_4335
912			\|a GBV_ILN_4336
912			\|a GBV_ILN_4338
912			\|a GBV_ILN_4393
912			\|a GBV_ILN_4700
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982			\|2 2013 \|1 01 \|x DE-16-250 \|8 04 \|s p \|0 (DE-627)1450272401 \|a Kieser, Meinhard
982			\|2 2013 \|1 01 \|x DE-16-250 \|8 04 \|s k \|0 (DE-627)1416741593 \|a Institut für Medizinische Biometrie und Informatik
982			\|2 2013 \|1 01 \|x DE-16-250 \|8 04 \|s s \|0 (DE-627)1410501914 \|a Verfasser
982			\|2 2013 \|1 01 \|x DE-16-250 \|8 04 \|s s \|a pos_1
982			\|2 2013 \|1 01 \|x DE-16-250 \|8 05 \|s p \|0 (DE-627)1448427592 \|a Rauch, Geraldine
982			\|2 2013 \|1 01 \|x DE-16-250 \|8 05 \|s k \|0 (DE-627)1416741593 \|a Institut für Medizinische Biometrie und Informatik
982			\|2 2013 \|1 01 \|x DE-16-250 \|8 05 \|s k \|0 (DE-627)1416466967 \|a Medizinische Fakultät Heidelberg
982			\|2 2013 \|1 01 \|x DE-16-250 \|8 05 \|s s \|0 (DE-627)1410501914 \|a Verfasser
982			\|2 2013 \|1 01 \|x DE-16-250 \|8 05 \|s s \|a pos_2

Indexfelder

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oclc_num	1341342217
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publishDate	2015
allfields	10.1002/sim.6487 doi (DE-627)1703023420 (DE-599)KXP1703023420 (OCoLC)1341342217 DE-627 ger DE-627 rda eng Kieser, Meinhard verfasserin (DE-588)103276547X (DE-627)739277766 (DE-576)168963825 aut Two-stage designs for cross-over bioequivalence trials Meinhard Kieser and Geraldine Rauch 24 March 2015 14 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 01.07.2020 The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non-inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid-course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd. adaptive design bioequivalence cross-over design sample size recalculation two-stage design Rauch, Geraldine verfasserin (DE-588)139823492 (DE-627)61378944X (DE-576)313422923 aut Enthalten in Statistics in medicine Chichester [u.a.] : Wiley, 1982 34(2015), 16, Seite 2403-2416 Online-Ressource (DE-627)30246719X (DE-600)1491221-1 (DE-576)079719686 1097-0258 nnns volume:34 year:2015 number:16 pages:2403-2416 extent:14 https://doi.org/10.1002/sim.6487 Resolving-System Verlag lizenzpflichtig Volltext https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.6487 Verlag lizenzpflichtig Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_266 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 34 2015 16 2403-2416 14 2013 01 DE-16-250 369264051X 00 --%%-- --%%-- --%%-- --%%-- l01 01-07-20 2013 01 DE-16-250 00 s hd2015 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_2 2013 01 DE-16-250 03 s s_14 2013 01 DE-16-250 04 p (DE-627)1450272401 Kieser, Meinhard 2013 01 DE-16-250 04 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_1 2013 01 DE-16-250 05 p (DE-627)1448427592 Rauch, Geraldine 2013 01 DE-16-250 05 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 05 k (DE-627)1416466967 Medizinische Fakultät Heidelberg 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_2
spelling	10.1002/sim.6487 doi (DE-627)1703023420 (DE-599)KXP1703023420 (OCoLC)1341342217 DE-627 ger DE-627 rda eng Kieser, Meinhard verfasserin (DE-588)103276547X (DE-627)739277766 (DE-576)168963825 aut Two-stage designs for cross-over bioequivalence trials Meinhard Kieser and Geraldine Rauch 24 March 2015 14 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 01.07.2020 The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non-inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid-course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd. adaptive design bioequivalence cross-over design sample size recalculation two-stage design Rauch, Geraldine verfasserin (DE-588)139823492 (DE-627)61378944X (DE-576)313422923 aut Enthalten in Statistics in medicine Chichester [u.a.] : Wiley, 1982 34(2015), 16, Seite 2403-2416 Online-Ressource (DE-627)30246719X (DE-600)1491221-1 (DE-576)079719686 1097-0258 nnns volume:34 year:2015 number:16 pages:2403-2416 extent:14 https://doi.org/10.1002/sim.6487 Resolving-System Verlag lizenzpflichtig Volltext https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.6487 Verlag lizenzpflichtig Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_266 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 34 2015 16 2403-2416 14 2013 01 DE-16-250 369264051X 00 --%%-- --%%-- --%%-- --%%-- l01 01-07-20 2013 01 DE-16-250 00 s hd2015 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_2 2013 01 DE-16-250 03 s s_14 2013 01 DE-16-250 04 p (DE-627)1450272401 Kieser, Meinhard 2013 01 DE-16-250 04 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_1 2013 01 DE-16-250 05 p (DE-627)1448427592 Rauch, Geraldine 2013 01 DE-16-250 05 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 05 k (DE-627)1416466967 Medizinische Fakultät Heidelberg 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_2
allfields_unstemmed	10.1002/sim.6487 doi (DE-627)1703023420 (DE-599)KXP1703023420 (OCoLC)1341342217 DE-627 ger DE-627 rda eng Kieser, Meinhard verfasserin (DE-588)103276547X (DE-627)739277766 (DE-576)168963825 aut Two-stage designs for cross-over bioequivalence trials Meinhard Kieser and Geraldine Rauch 24 March 2015 14 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 01.07.2020 The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non-inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid-course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd. adaptive design bioequivalence cross-over design sample size recalculation two-stage design Rauch, Geraldine verfasserin (DE-588)139823492 (DE-627)61378944X (DE-576)313422923 aut Enthalten in Statistics in medicine Chichester [u.a.] : Wiley, 1982 34(2015), 16, Seite 2403-2416 Online-Ressource (DE-627)30246719X (DE-600)1491221-1 (DE-576)079719686 1097-0258 nnns volume:34 year:2015 number:16 pages:2403-2416 extent:14 https://doi.org/10.1002/sim.6487 Resolving-System Verlag lizenzpflichtig Volltext https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.6487 Verlag lizenzpflichtig Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_266 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 34 2015 16 2403-2416 14 2013 01 DE-16-250 369264051X 00 --%%-- --%%-- --%%-- --%%-- l01 01-07-20 2013 01 DE-16-250 00 s hd2015 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_2 2013 01 DE-16-250 03 s s_14 2013 01 DE-16-250 04 p (DE-627)1450272401 Kieser, Meinhard 2013 01 DE-16-250 04 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_1 2013 01 DE-16-250 05 p (DE-627)1448427592 Rauch, Geraldine 2013 01 DE-16-250 05 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 05 k (DE-627)1416466967 Medizinische Fakultät Heidelberg 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_2
allfieldsGer	10.1002/sim.6487 doi (DE-627)1703023420 (DE-599)KXP1703023420 (OCoLC)1341342217 DE-627 ger DE-627 rda eng Kieser, Meinhard verfasserin (DE-588)103276547X (DE-627)739277766 (DE-576)168963825 aut Two-stage designs for cross-over bioequivalence trials Meinhard Kieser and Geraldine Rauch 24 March 2015 14 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 01.07.2020 The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non-inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid-course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd. adaptive design bioequivalence cross-over design sample size recalculation two-stage design Rauch, Geraldine verfasserin (DE-588)139823492 (DE-627)61378944X (DE-576)313422923 aut Enthalten in Statistics in medicine Chichester [u.a.] : Wiley, 1982 34(2015), 16, Seite 2403-2416 Online-Ressource (DE-627)30246719X (DE-600)1491221-1 (DE-576)079719686 1097-0258 nnns volume:34 year:2015 number:16 pages:2403-2416 extent:14 https://doi.org/10.1002/sim.6487 Resolving-System Verlag lizenzpflichtig Volltext https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.6487 Verlag lizenzpflichtig Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_266 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 34 2015 16 2403-2416 14 2013 01 DE-16-250 369264051X 00 --%%-- --%%-- --%%-- --%%-- l01 01-07-20 2013 01 DE-16-250 00 s hd2015 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_2 2013 01 DE-16-250 03 s s_14 2013 01 DE-16-250 04 p (DE-627)1450272401 Kieser, Meinhard 2013 01 DE-16-250 04 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_1 2013 01 DE-16-250 05 p (DE-627)1448427592 Rauch, Geraldine 2013 01 DE-16-250 05 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 05 k (DE-627)1416466967 Medizinische Fakultät Heidelberg 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_2
allfieldsSound	10.1002/sim.6487 doi (DE-627)1703023420 (DE-599)KXP1703023420 (OCoLC)1341342217 DE-627 ger DE-627 rda eng Kieser, Meinhard verfasserin (DE-588)103276547X (DE-627)739277766 (DE-576)168963825 aut Two-stage designs for cross-over bioequivalence trials Meinhard Kieser and Geraldine Rauch 24 March 2015 14 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Gesehen am 01.07.2020 The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non-inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid-course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd. adaptive design bioequivalence cross-over design sample size recalculation two-stage design Rauch, Geraldine verfasserin (DE-588)139823492 (DE-627)61378944X (DE-576)313422923 aut Enthalten in Statistics in medicine Chichester [u.a.] : Wiley, 1982 34(2015), 16, Seite 2403-2416 Online-Ressource (DE-627)30246719X (DE-600)1491221-1 (DE-576)079719686 1097-0258 nnns volume:34 year:2015 number:16 pages:2403-2416 extent:14 https://doi.org/10.1002/sim.6487 Resolving-System Verlag lizenzpflichtig Volltext https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.6487 Verlag lizenzpflichtig Volltext GBV_USEFLAG_U GBV_ILN_2013 ISIL_DE-16-250 SYSFLAG_1 GBV_KXP SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_252 GBV_ILN_266 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 34 2015 16 2403-2416 14 2013 01 DE-16-250 369264051X 00 --%%-- --%%-- --%%-- --%%-- l01 01-07-20 2013 01 DE-16-250 00 s hd2015 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_2 2013 01 DE-16-250 03 s s_14 2013 01 DE-16-250 04 p (DE-627)1450272401 Kieser, Meinhard 2013 01 DE-16-250 04 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_1 2013 01 DE-16-250 05 p (DE-627)1448427592 Rauch, Geraldine 2013 01 DE-16-250 05 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 05 k (DE-627)1416466967 Medizinische Fakultät Heidelberg 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_2
language	English
source	Enthalten in Statistics in medicine 34(2015), 16, Seite 2403-2416 volume:34 year:2015 number:16 pages:2403-2416 extent:14
sourceStr	Enthalten in Statistics in medicine 34(2015), 16, Seite 2403-2416 volume:34 year:2015 number:16 pages:2403-2416 extent:14
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topic_facet	adaptive design bioequivalence cross-over design sample size recalculation two-stage design
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authorswithroles_txt_mv	Kieser, Meinhard @@aut@@ Rauch, Geraldine @@aut@@
publishDateDaySort_date	2015-01-01T00:00:00Z
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author	Kieser, Meinhard
spellingShingle	Kieser, Meinhard misc adaptive design misc bioequivalence misc cross-over design misc sample size recalculation misc two-stage design 2013 hd2015 2013 wissenschaftlicher Artikel (Zeitschrift) 2013 per_2 2013 s_14 2013 Kieser, Meinhard 2013 Institut für Medizinische Biometrie und Informatik 2013 Verfasser 2013 pos_1 2013 Rauch, Geraldine 2013 Medizinische Fakultät Heidelberg 2013 pos_2 Two-stage designs for cross-over bioequivalence trials
authorStr	Kieser, Meinhard
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issn	1097-0258
topic_title	2013 01 DE-16-250 00 s hd2015 2013 01 DE-16-250 01 s (DE-627)1410508463 wissenschaftlicher Artikel (Zeitschrift) 2013 01 DE-16-250 02 s per_2 2013 01 DE-16-250 03 s s_14 2013 01 DE-16-250 04 p (DE-627)1450272401 Kieser, Meinhard 2013 01 DE-16-250 04 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 04 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 04 s pos_1 2013 01 DE-16-250 05 p (DE-627)1448427592 Rauch, Geraldine 2013 01 DE-16-250 05 k (DE-627)1416741593 Institut für Medizinische Biometrie und Informatik 2013 01 DE-16-250 05 k (DE-627)1416466967 Medizinische Fakultät Heidelberg 2013 01 DE-16-250 05 s (DE-627)1410501914 Verfasser 2013 01 DE-16-250 05 s pos_2 Two-stage designs for cross-over bioequivalence trials Meinhard Kieser and Geraldine Rauch adaptive design bioequivalence cross-over design sample size recalculation two-stage design
topic	misc adaptive design misc bioequivalence misc cross-over design misc sample size recalculation misc two-stage design 2013 hd2015 2013 wissenschaftlicher Artikel (Zeitschrift) 2013 per_2 2013 s_14 2013 Kieser, Meinhard 2013 Institut für Medizinische Biometrie und Informatik 2013 Verfasser 2013 pos_1 2013 Rauch, Geraldine 2013 Medizinische Fakultät Heidelberg 2013 pos_2
topic_unstemmed	misc adaptive design misc bioequivalence misc cross-over design misc sample size recalculation misc two-stage design 2013 hd2015 2013 wissenschaftlicher Artikel (Zeitschrift) 2013 per_2 2013 s_14 2013 Kieser, Meinhard 2013 Institut für Medizinische Biometrie und Informatik 2013 Verfasser 2013 pos_1 2013 Rauch, Geraldine 2013 Medizinische Fakultät Heidelberg 2013 pos_2
topic_browse	misc adaptive design misc bioequivalence misc cross-over design misc sample size recalculation misc two-stage design 2013 hd2015 2013 wissenschaftlicher Artikel (Zeitschrift) 2013 per_2 2013 s_14 2013 Kieser, Meinhard 2013 Institut für Medizinische Biometrie und Informatik 2013 Verfasser 2013 pos_1 2013 Rauch, Geraldine 2013 Medizinische Fakultät Heidelberg 2013 pos_2
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title	Two-stage designs for cross-over bioequivalence trials
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title_full	Two-stage designs for cross-over bioequivalence trials Meinhard Kieser and Geraldine Rauch
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title_sort	two-stage designs for cross-over bioequivalence trials
title_auth	Two-stage designs for cross-over bioequivalence trials
abstract	The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non-inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid-course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd. Gesehen am 01.07.2020
abstractGer	The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non-inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid-course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd. Gesehen am 01.07.2020
abstract_unstemmed	The topic of applying two-stage designs in the field of bioequivalence studies has recently gained attention in the literature and in regulatory guidelines. While there exists some methodological research on the application of group sequential designs in bioequivalence studies, implementation of adaptive approaches has focused up to now on superiority and non-inferiority trials. Especially, no comparison of the features and performance characteristics of these designs has been performed, and therefore, the question of which design to employ in this setting remains open. In this paper, we discuss and compare ‘classical’ group sequential designs and three types of adaptive designs that offer the option of mid-course sample size recalculation. A comprehensive simulation study demonstrates that group sequential designs can be identified, which show power characteristics that are similar to those of the adaptive designs but require a lower average sample size. The methods are illustrated with a real bioequivalence study example. Copyright © 2015 John Wiley & Sons, Ltd. Gesehen am 01.07.2020
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title_short	Two-stage designs for cross-over bioequivalence trials
url	https://doi.org/10.1002/sim.6487 https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.6487
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Two-stage designs for cross-over bioequivalence trials

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