Bioequivalence and Bioavailability Forum • tada: Another issue with FDA's RSABE (please confirm?)

tada: Another issue with FDA's RSABE (please confirm?) [RSABE / ABEL]

posted by jag009 – NJ, 2013-12-19 18:41 (4575 d 01:16 ago) – Posting: # 12081
Views: 11,644
(edited on 2013-12-19 20:13)

Hi guys,

It seems like I encountered another problem with FDA's SAS code for calculating 90% CI using the PROC Mixed procedure. The parameters did not qualify for RSABE assessment. This time I don't have any missing data. Sorry Helmut if the data is too long. dataset is space limited. SAS and WinNonlin gurus, please confirm?

My SAS output showed:

For AUCt: WARNING: Did not converge.

For AUCi (I don't think this is a problem(?)):
NOTE: Convergence criteria met but final hessian is not positive definite.
NOTE: Asymptotic variance matrix of covariance parameter estimates has been found to be singular and a generalized inverse was used. Covariance parameters with zero variance do not contribute to degrees of freedom computed by DDFM=SATTERTH.

The fields are: Subject, Sequence, Period, Treatment, AUCt, AUCi
Sequence: 1 = AB₁B₂, 2=B₁AB₂, 3=B₁B₂A

1 2 2 1 1986.987 2028.539

2 3 3 1 2411.950 2526.036

3 1 1 1 1690.350 1770.166

4 3 3 1 5814.296 5922.447

5 2 2 1 4414.033 4882.854

6 1 1 1 7464.493 8706.046

7 1 1 1 6134.403 6354.843

8 2 2 1 1613.515 1691.363

9 3 3 1 3448.915 3688.104

10 3 3 1 1290.754 1389.463

11 1 1 1 6401.609 6489.934

12 2 2 1 4115.371 4179.525

13 2 2 1 2440.672 2711.280

14 3 3 1 940.629 1326.512

15 1 1 1 2390.001 2507.927

16 2 2 1 1011.974 1084.656

17 3 3 1 1425.998 2071.054

18 1 1 1 3756.342 3818.330

19 2 2 1 2788.777 2876.920

20 3 3 1 4482.295 4569.567

21 1 1 1 4765.237 5033.406

22 1 1 1 2818.664 2963.035

23 2 2 1 3721.059 5315.704

24 3 3 1 1651.403 2359.010

25 3 3 1 4550.919 4602.326

26 1 1 1 3249.760 3402.651

27 2 2 1 1359.468 1487.107

28 1 1 1 4084.693 4440.407

29 3 3 1 632.116 655.684

30 2 2 1 1996.837 2265.452

31 3 3 1 3786.507 4359.212

32 2 2 1 2292.445 2498.451

33 1 1 1 3688.778 3936.592

34 1 1 1 5123.381 5191.885

35 2 2 1 3075.198 3498.299

36 3 3 1 3700.028 3871.734

37 1 1 1 3927.375 4163.267

38 3 3 1 3888.209 4011.221

40 3 3 1 3067.678 3250.625

41 1 1 1 2324.201 2458.099

43 1 1 1 1569.884 2435.485

44 3 3 1 3508.294 4372.614

45 2 2 1 1854.899 2213.825

46 1 1 1 4608.492 4713.071

47 2 2 1 1571.500 1902.432

48 3 3 1 2675.384 2755.825

49 2 2 1 2078.712 4101.855

50 1 1 1 2638.387 3046.370

51 3 3 1 3938.841 4051.813

52 2 2 1 4639.706 5237.773

53 1 1 1 6743.505 7953.264

54 3 3 1 5228.621 5486.796

55 2 2 1 1523.521 1610.193

56 1 1 1 3919.978 3967.199

57 3 3 1 2525.702 2802.588

59 3 3 1 5293.810 5518.208

60 2 2 1 5762.699 7522.105

61 1 1 1 1791.163 1935.079

62 2 2 1 3560.518 3890.326

63 3 3 1 2018.500 2167.172

64 3 3 1 639.486 750.382

65 2 2 1 8435.241 8598.730

66 1 1 1 2335.596 2789.875

67 2 2 1 1854.219 4973.702

68 1 1 1 4767.972 4886.123

69 3 3 1 8523.859 8614.662

70 3 3 1 1992.374 2076.292

71 1 1 1 5891.358 6048.819

72 2 2 1 3509.377 3631.466

73 1 1 1 2300.501 2385.739

74 3 3 1 3014.357 3327.482

76 1 1 1 2190.961 3533.236

77 3 3 1 5108.458 5209.829

78 2 2 1 2454.949 2723.965

79 1 1 1 8335.814 8443.137

80 2 2 1 4809.817 4900.255

81 3 3 1 6255.335 6785.737

82 1 1 1 713.013 3248.165

83 3 3 1 1777.401 2419.373

84 2 2 1 2454.707 2554.941

85 1 1 1 2905.955 2959.859

86 2 2 1 950.031 1347.994

87 3 3 1 3072.612 3169.770

88 1 1 1 1404.276 1565.716

89 3 3 1 5634.534 5805.369

90 2 2 1 1972.698 3015.333

91 1 1 1 6044.275 6317.111

92 3 3 1 4140.777 4194.132

93 2 2 1 2587.609 3041.097

94 3 3 1 2981.478 3308.986

95 2 2 1 3161.578 3361.797

96 1 1 1 4359.266 4481.890

97 2 2 1 6445.984 6557.993

98 3 3 1 3313.374 3419.453

99 1 1 1 1752.319 2279.186

100 2 2 1 3157.205 3336.087

103 2 2 1 1646.301 1700.174

104 1 1 1 4166.170 4357.331

106 1 1 1 2845.445 3068.462

107 3 3 1 2098.512 3342.156

109 1 1 1 1968.416 2025.039

110 3 3 1 2142.577 3182.653

111 2 2 1 5322.128 5591.891

112 3 3 1 1570.012 1740.816

113 2 2 1 2602.400 2654.715

114 1 1 1 2509.354 2671.323

115 1 1 1 4391.295 4540.127

117 2 2 1 2947.856 3175.737

118 3 3 1 2847.161 2930.837

119 1 1 1 4477.920 4525.512

120 2 2 1 1252.486 1319.169

121 3 3 1 3919.694 3979.781

122 1 1 1 3131.665 3495.320

123 2 2 1 3966.638 4562.475

124 1 1 1 9507.404 13363.943

125 3 3 1 5163.216 5931.813

126 2 2 1 9142.358 9341.179

1 2 1 2 1393.955 1696.903

1 2 3 2 3505.870 3608.707

2 3 1 2 3736.474 4020.712

2 3 2 2 2515.933 2701.962

3 1 2 2 4269.521 5560.004

3 1 3 2 1944.560 2193.368

4 3 1 2 10714.492 10827.848

4 3 2 2 3366.038 3503.346

5 2 1 2 4425.526 4747.656

5 2 3 2 3802.169 4404.318

6 1 2 2 4814.234 5175.735

6 1 3 2 6650.650 7587.377

7 1 2 2 10340.443 10534.260

7 1 3 2 4363.923 4516.547

8 2 1 2 1541.656 1593.710

8 2 3 2 2096.269 2423.027

9 3 1 2 3883.217 3951.200

9 3 2 2 3469.208 3679.107

10 3 1 2 1158.412 1598.101

10 3 2 2 1684.590 1771.260

11 1 2 2 8529.765 8652.602

11 1 3 2 8589.721 8724.174

12 2 1 2 2838.978 2955.794

12 2 3 2 2558.276 2662.546

13 2 1 2 2825.109 3045.681

13 2 3 2 1832.087 1997.048

14 3 1 2 1692.009 1754.715

14 3 2 2 2179.266 2322.747

15 1 2 2 3954.950 4017.519

15 1 3 2 2406.415 2448.923

16 2 1 2 1864.904 2008.329

16 2 3 2 1010.471 1197.877

17 3 1 2 1581.669 2339.947

17 3 2 2 1703.455 1782.926

18 1 2 2 2641.073 2822.153

18 1 3 2 2077.247 2141.970

19 2 1 2 3443.842 3512.693

19 2 3 2 2523.653 2742.111

20 3 1 2 2329.852 2928.550

20 3 2 2 3633.168 3679.938

21 1 2 2 5309.433 6265.735

21 1 3 2 3486.541 3589.547

22 1 2 2 2300.887 2612.660

22 1 3 2 2822.703 2961.982

23 2 1 2 2932.020 3026.017

23 2 3 2 3180.072 3275.972

24 3 1 2 4939.731 5099.487

24 3 2 2 6323.412 6404.058

25 3 1 2 5245.106 5302.180

25 3 2 2 5835.787 5992.491

26 1 2 2 1825.066 2010.360

26 1 3 2 3176.108 3287.679

27 2 1 2 1246.217 1897.647

27 2 3 2 1483.842 2159.919

28 1 2 2 3339.691 3549.645

28 1 3 2 2828.209 2959.100

29 3 1 2 863.188 890.382

29 3 2 2 650.852 675.257

30 2 1 2 1668.825 2028.178

30 2 3 2 2208.537 2561.781

31 3 1 2 4622.568 5118.419

31 3 2 2 4076.484 4564.566

32 2 1 2 3806.165 4177.127

32 2 3 2 3107.501 4118.659

33 1 2 2 2800.694 3202.677

33 1 3 2 3571.575 3772.260

34 1 2 2 4013.862 4091.954

34 1 3 2 3715.673 3833.044

35 2 1 2 2436.009 2782.867

35 2 3 2 3939.625 4241.525

36 3 1 2 2945.222 3078.332

36 3 2 2 4257.185 4311.668

37 1 2 2 4357.906 4472.984

37 1 3 2 3457.290 4137.185

38 3 1 2 3342.971 3439.184

38 3 2 2 4758.602 5012.171

40 3 1 2 3293.343 3709.858

40 3 2 2 1754.860 1816.881

41 1 2 2 2317.643 3100.998

41 1 3 2 2203.879 2497.227

43 1 2 2 1545.947 2316.025

43 1 3 2 1286.978 1418.360

44 3 1 2 4243.010 6262.912

44 3 2 2 3644.791 4708.170

45 2 1 2 2120.351 2239.488

45 2 3 2 2288.949 2401.353

46 1 2 2 5695.575 5798.696

46 1 3 2 6462.232 6657.683

47 2 1 2 2680.581 2762.981

47 2 3 2 2478.744 2888.345

48 3 1 2 4035.800 4110.881

48 3 2 2 2688.206 2827.054

49 2 1 2 1714.493 4334.532

49 2 3 2 2119.548 2453.837

50 1 2 2 5800.021 5888.889

50 1 3 2 1949.246 2192.628

51 3 1 2 4231.754 4738.621

51 3 2 2 3986.447 4385.957

52 2 1 2 3029.317 3674.960

52 2 3 2 4321.629 4592.441

53 1 2 2 7883.749 8101.335

53 1 3 2 5953.973 6241.813

54 3 1 2 6055.951 6502.790

54 3 2 2 5602.754 5859.172

55 2 1 2 3339.720 3426.866

55 2 3 2 3288.800 3391.971

56 1 2 2 4609.794 4841.331

56 1 3 2 3041.170 3261.202

57 3 1 2 2413.777 2767.540

57 3 2 2 2056.104 2255.159

59 3 1 2 3297.598 3764.997

59 3 2 2 2597.781 2743.093

60 2 1 2 6415.028 6636.392

60 2 3 2 6536.282 6912.101

61 1 2 2 1977.866 2070.410

61 1 3 2 1992.784 2083.171

62 2 1 2 4262.586 5392.059

62 2 3 2 4156.121 4284.027

63 3 1 2 1411.091 1473.652

63 3 2 2 1347.625 1522.727

64 3 1 2 814.878 991.637

64 3 2 2 1017.093 1101.514

65 2 1 2 6888.502 6959.243

65 2 3 2 8521.035 8602.048

66 1 2 2 3502.722 3712.982

66 1 3 2 3003.672 3202.768

67 2 1 2 4786.897 4921.378

67 2 3 2 2451.677 2517.846

68 1 2 2 3734.920 4015.660

68 1 3 2 2799.735 3043.947

69 3 1 2 4167.764 4316.579

69 3 2 2 5235.564 5297.359

70 3 1 2 2919.263 3048.971

70 3 2 2 2298.465 2520.636

71 1 2 2 6084.365 6157.185

71 1 3 2 5605.379 5634.624

72 2 1 2 2238.601 2377.907

72 2 3 2 2065.535 2147.259

73 1 2 2 2357.455 2451.162

73 1 3 2 3319.716 3466.406

74 3 1 2 1805.151 3700.507

74 3 2 2 3633.153 3666.874

76 1 2 2 4431.239 4492.829

76 1 3 2 3306.066 3368.552

77 3 1 2 5101.865 6838.827

77 3 2 2 3463.045 3787.538

78 2 1 2 3672.702 3884.331

78 2 3 2 2935.212 3729.577

79 1 2 2 5364.212 5441.344

79 1 3 2 8249.717 8554.513

80 2 1 2 3998.482 4184.930

80 2 3 2 4080.722 4298.298

81 3 1 2 5230.484 5339.276

81 3 2 2 5588.193 6372.836

82 1 2 2 2076.243 2254.340

82 1 3 2 1830.994 2790.836

83 3 1 2 1578.507 2105.984

83 3 2 2 2229.508 3109.140

84 2 1 2 2797.427 2880.782

84 2 3 2 2197.208 2429.935

85 1 2 2 5033.550 5168.372

85 1 3 2 3192.892 3358.880

86 2 1 2 1233.338 1322.313

86 2 3 2 2057.456 2341.459

87 3 1 2 2707.480 2782.544

87 3 2 2 2787.796 2894.282

88 1 2 2 1010.611 1269.911

88 1 3 2 1301.015 1393.945

89 3 1 2 5737.302 5818.926

89 3 2 2 6840.293 6910.318

90 2 1 2 2254.840 2708.719

90 2 3 2 1909.054 1984.713

91 1 2 2 6091.191 6289.288

91 1 3 2 8476.264 8943.856

92 3 1 2 5577.091 5986.726

92 3 2 2 4511.606 4669.532

93 2 1 2 831.347 1478.894

93 2 3 2 1404.214 1759.693

94 3 1 2 3877.871 3965.294

94 3 2 2 3317.100 3429.038

95 2 1 2 1948.567 2021.957

95 2 3 2 2440.997 2540.043

96 1 2 2 4032.920 4082.632

96 1 3 2 5007.126 5081.079

97 2 1 2 4966.626 5123.627

97 2 3 2 3792.665 3959.180

98 3 1 2 3390.648 3612.219

98 3 2 2 4496.329 4710.963

99 1 2 2 1821.359 2069.192

99 1 3 2 1328.736 1458.837

100 2 1 2 2254.175 2347.780

100 2 3 2 3602.854 3653.128

103 2 1 2 667.938 994.301

103 2 3 2 1881.014 1996.641

104 1 2 2 4412.429 4807.663

104 1 3 2 7269.143 7710.601

106 1 2 2 5727.482 5869.246

106 1 3 2 2489.764 2842.016

107 3 1 2 2522.239 2957.417

107 3 2 2 3220.742 3709.728

109 1 2 2 1543.887 1814.762

109 1 3 2 1310.696 1408.024

110 3 1 2 3831.757 4083.170

110 3 2 2 3059.492 3752.390

111 2 1 2 2419.770 2549.026

111 2 3 2 4323.227 4395.120

112 3 1 2 2309.067 2424.960

112 3 2 2 2908.746 3013.112

113 2 1 2 3003.194 3337.953

113 2 3 2 3831.171 4018.417

114 1 2 2 2856.754 2929.591

114 1 3 2 3209.380 3390.930

115 1 2 2 2751.360 2856.454

115 1 3 2 5202.542 5586.009

116 3 1 2 2157.130 2331.448

116 3 2 2 2301.391 2813.132

117 2 1 2 2702.549 2801.745

117 2 3 2 2083.111 2226.822

118 3 1 2 4113.503 4268.438

118 3 2 2 4470.444 4773.996

119 1 2 2 2577.045 2783.993

119 1 3 2 3534.523 3606.611

120 2 1 2 2235.692 2274.964

120 2 3 2 1367.220 1480.401

121 3 1 2 3383.035 3466.498

121 3 2 2 5317.416 6265.831

122 1 2 2 4307.590 4626.598

122 1 3 2 6508.045 7454.215

123 2 1 2 4569.969 4952.604

123 2 3 2 4789.485 5290.609

124 1 2 2 5837.689 7092.132

124 1 3 2 5066.133 6194.666

125 3 1 2 5285.137 5346.401

125 3 2 2 2468.586 3700.238

126 2 1 2 4807.900 5011.201

126 2 3 2 4517.280 4559.176

Thanks

John

Complete thread:

tada: Another issue with FDA's RSABE (please confirm?)jag009 2013-12-19 17:41
- Phoenix/WinNonlin: not confirmed Helmut 2013-12-20 04:13
  - Phoenix/WinNonlin: not confirmed jag009 2013-12-20 17:12
    - TRT|RTR or FA0(1) Helmut 2013-12-20 17:37
      - TRT|RTR or FA0(1) jag009 2013-12-20 21:24
      - Partial replicate crap? Really? d_labes 2013-12-23 09:18
        
        Partial replicate crap? Really? Helmut 2013-12-23 14:06
- Tweak & Fiddle ElMaestro 2013-12-20 14:32
  - Tweak & Fiddle jag009 2013-12-20 17:16
- Not confirmed - SAS d_labes 2013-12-23 10:14