data_2x2.RdThese data.frames give sample size tables calculated with
sampleN.TOST() for the 2×2 design.
The data.frames can be accessed by their names.
| data.frame | Description |
| ct5.1 | Multiplicative model, theta1=0.8, theta2=1.25 (1/theta1), exact |
| ct5.2 | Multiplicative model, theta1=0.75, theta2=1.3333 (1/theta1), exact |
| ct5.3 | Multiplicative model, theta1=0.9, theta2=1.1111 (1/theta1), exact |
| ct5.4.1 | Additive model, theta1=–0.2, theta2=+0.2 (BE limits 0.80 – 1.20), exact |
| data.frame | Origin | Details |
| ct5.1 | Hauschke et al. | Table 5.1 (p 113–114) |
| ct5.2 | Hauschke et al. | Table 5.2 (p 115–116) |
| ct5.3 | Hauschke et al. | Table 5.3 (p 118) |
| ct5.4.1 | Chow & Liu | Table 5.4.1 (p 158) |
Hauschke D, Steinijans VW, Pigeot I. Bioequivalence Studies in Drug Development. Chichester: John Wiley; 2007.
Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies. Boca Raton: CRC Press; 3rd edition 2009.
Scripts for creation of these data.frames can be found in the /tests
sub-directory of the package.
Comparing the results of these scripts to the corresponding data.frames can
be used for validation purposes.
ct5.1
#> power CV R0.85 R0.9 R0.95 R1.0 R1.05 R1.1 R1.15 R1.2
#> 1 0.8 0.100 36 12 8 6 8 10 20 76
#> 2 0.8 0.125 54 16 10 8 10 14 30 118
#> 3 0.8 0.150 78 22 12 10 12 20 42 168
#> 4 0.8 0.175 104 30 16 14 16 26 56 226
#> 5 0.8 0.200 134 38 20 16 18 32 72 294
#> 6 0.8 0.225 168 46 24 20 24 40 90 368
#> 7 0.8 0.250 206 56 28 24 28 48 110 452
#> 8 0.8 0.275 248 68 34 28 34 58 132 544
#> 9 0.8 0.300 292 80 40 32 38 68 156 642
#> 10 0.8 0.325 340 92 46 36 44 78 180 748
#> 11 0.8 0.350 392 106 52 42 50 90 208 860
#> 12 0.8 0.375 446 120 58 48 58 102 236 978
#> 13 0.8 0.400 502 134 66 54 64 114 266 1104
#> 14 0.9 0.100 48 14 8 8 8 14 26 104
#> 15 0.9 0.125 74 22 12 10 12 18 40 162
#> 16 0.9 0.150 106 30 16 12 16 26 58 232
#> 17 0.9 0.175 142 40 20 16 20 34 76 312
#> 18 0.9 0.200 186 50 26 20 24 44 100 406
#> 19 0.9 0.225 232 64 32 24 30 54 124 510
#> 20 0.9 0.250 284 78 38 28 36 66 152 626
#> 21 0.9 0.275 342 92 44 34 44 78 182 752
#> 22 0.9 0.300 404 108 52 40 52 92 214 888
#> 23 0.9 0.325 470 126 60 46 60 108 250 1034
#> 24 0.9 0.350 540 146 70 52 68 124 288 1190
#> 25 0.9 0.375 616 164 80 60 78 140 326 1354
#> 26 0.9 0.400 694 186 88 66 86 158 368 1528
ct5.2
#> power CV R0.8 R0.85 R0.9 R0.95 R1.0 R1.05 R1.1 R1.15 R1.2 R1.25
#> 1 0.8 0.150 68 20 10 8 8 8 10 16 28 68
#> 2 0.8 0.175 92 26 14 10 10 10 12 20 36 92
#> 3 0.8 0.200 118 34 18 12 10 12 16 24 46 118
#> 4 0.8 0.225 148 42 20 14 12 14 20 30 58 148
#> 5 0.8 0.250 182 50 26 16 16 16 22 36 70 182
#> 6 0.8 0.275 218 60 30 20 18 20 26 44 84 218
#> 7 0.8 0.300 258 70 34 22 20 22 32 52 98 258
#> 8 0.8 0.325 300 82 40 26 24 26 36 60 114 300
#> 9 0.8 0.350 346 94 46 30 26 30 42 68 132 346
#> 10 0.8 0.375 392 106 52 34 30 34 46 76 148 392
#> 11 0.8 0.400 442 120 58 38 34 36 52 86 168 442
#> 12 0.8 0.425 496 134 64 42 36 42 58 96 188 496
#> 13 0.8 0.450 550 148 72 46 40 46 64 106 208 550
#> 14 0.9 0.150 94 26 14 10 8 10 12 20 36 94
#> 15 0.9 0.175 126 36 18 12 10 12 16 26 48 126
#> 16 0.9 0.200 164 46 22 14 12 14 20 34 62 164
#> 17 0.9 0.225 206 56 28 18 16 18 26 42 78 206
#> 18 0.9 0.250 252 68 34 22 18 22 30 50 96 252
#> 19 0.9 0.275 302 82 40 26 22 24 36 60 114 302
#> 20 0.9 0.300 356 96 46 30 26 28 42 70 136 356
#> 21 0.9 0.325 416 112 54 34 28 34 48 80 158 416
#> 22 0.9 0.350 478 128 62 38 32 38 56 92 180 478
#> 23 0.9 0.375 544 146 70 44 36 42 64 106 206 544
#> 24 0.9 0.400 612 164 78 48 42 48 72 118 232 612
#> 25 0.9 0.425 686 184 88 54 46 54 80 132 258 686
#> 26 0.9 0.450 760 204 98 60 50 60 88 146 286 760
ct5.3
#> power CV R0.925 R0.95 R0.975 R1.0 R1.025 R1.05 R1.075
#> 1 0.8 0.050 44 14 8 6 8 12 30
#> 2 0.8 0.075 94 26 14 12 14 24 66
#> 3 0.8 0.100 166 44 22 18 22 40 116
#> 4 0.8 0.125 258 68 32 26 32 62 178
#> 5 0.8 0.150 368 96 46 36 46 88 254
#> 6 0.8 0.175 500 130 62 48 62 118 344
#> 7 0.8 0.200 648 168 80 62 78 154 446
#> 8 0.8 0.225 816 212 100 78 98 194 562
#> 9 0.8 0.250 1000 258 122 96 120 236 690
#> 10 0.9 0.050 60 18 10 8 10 16 42
#> 11 0.9 0.075 130 36 18 14 18 32 90
#> 12 0.9 0.100 230 60 30 22 28 56 158
#> 13 0.9 0.125 356 94 44 32 44 86 246
#> 14 0.9 0.150 510 132 62 46 62 122 352
#> 15 0.9 0.175 690 180 84 62 82 164 476
#> 16 0.9 0.200 898 232 108 78 106 212 618
#> 17 0.9 0.225 1130 292 134 98 132 266 778
#> 18 0.9 0.250 1386 358 164 120 162 326 954
ct5.4.1
#> power CV R0.0 R0.05 R0.1 R0.15
#> 1 0.8 0.10 8 8 14 52
#> 2 0.8 0.12 8 10 20 74
#> 3 0.8 0.14 12 14 26 100
#> 4 0.8 0.16 14 16 34 128
#> 5 0.8 0.18 16 20 42 162
#> 6 0.8 0.20 20 24 52 200
#> 7 0.8 0.22 24 30 62 242
#> 8 0.8 0.24 28 34 74 288
#> 9 0.8 0.26 32 40 86 336
#> 10 0.8 0.28 36 46 100 390
#> 11 0.8 0.30 40 52 114 448
#> 12 0.8 0.32 46 60 128 508
#> 13 0.8 0.34 52 66 146 574
#> 14 0.8 0.36 58 74 162 644
#> 15 0.8 0.38 64 84 180 716
#> 16 0.8 0.40 70 92 200 794
#> 17 0.9 0.10 8 10 20 70
#> 18 0.9 0.12 10 14 28 102
#> 19 0.9 0.14 14 18 36 136
#> 20 0.9 0.16 16 22 46 178
#> 21 0.9 0.18 20 28 58 224
#> 22 0.9 0.20 24 32 70 276
#> 23 0.9 0.22 28 40 86 334
#> 24 0.9 0.24 34 46 102 396
#> 25 0.9 0.26 40 54 118 466
#> 26 0.9 0.28 44 62 136 540
#> 27 0.9 0.30 52 72 156 618
#> 28 0.9 0.32 58 80 178 704
#> 29 0.9 0.34 64 90 200 794
#> 30 0.9 0.36 72 102 224 890
#> 31 0.9 0.38 80 112 250 992
#> 32 0.9 0.40 88 124 276 1098