Bioequivalence and Bioavailability Forum

3x3 or 2x4? felipeberlinski 2014-10-22 14:20
- 3x3 or 2x4? ElMaestro 2014-10-22 14:42
  - 3x3 or 2x4? nobody 2014-10-22 15:06
    - 3x3 or 2x4? felipeberlinski 2014-10-22 15:36
      - 3x3 or 2x4? nobody 2014-10-22 15:41
      - 2x3x3 or 2x2x3 or 2x2x4? d_labes 2014-10-22 16:12
        
        2x3x3 or 2x2x3 or 2x2x4? MGR 2015-04-08 13:35
        
        Sample size for scABE in SAS? d_labes 2015-04-08 16:06
        Re-inventing the wheel Helmut 2015-04-08 16:19
- RTR|TRT Helmut 2014-10-22 16:36
- 3x3 or 2x4? Mauricio Sampaio 2014-10-28 12:12

Statistical Analysis section of partial replicate BE study cher0424 2015-01-07 06:39
- Subjects to be considered in partial replicate BE study d_labes 2015-01-07 14:45
  - Subjects to be considered in partial replicate BE study cher0424 2015-01-07 15:35
  - Subjects to be considered in partial replicate BE study cher0424 2015-01-08 06:28
    - Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:03
      - Subjects to be considered in partial replicate BE study cher0424 2015-01-08 09:51
        
        Subjects to be considered in partial replicate BE study d_labes 2015-01-08 10:27
        
        Subjects in replicate BE study EU/FDA Shuanghe 2015-01-08 11:08
        
        Subjects in replicate BE study EU/FDA cher0424 2015-01-08 13:56
        Subjects in replicate BE study EU/FDA Relaxation 2015-03-02 09:46
        
        Subjects in replicate BE study EU/FDA d_labes 2015-03-02 11:38
        Subjects in replicate BE study EU mittyri 2015-03-19 20:12
  - Subjects to be considered in partial replicate BE study Dr_Dan 2015-01-08 08:59
    - Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:04
      - Subjects to be considered in partial replicate BE study Astea 2015-03-01 18:12
        
        Subjects to be considered in partial replicate BE study yjlee168 2015-03-01 19:01
        
        Subjects to be considered in partial replicate BE study Astea 2015-03-09 14:43
        
        NCA with bear? yjlee168 2015-03-09 15:24
        
        Bear and null PK parameters mittyri 2015-03-25 09:50
        
        to exclude or not to exclude the subjects with bear? yjlee168 2015-03-28 21:03
        
        to exclude or not to exclude - let the user decide mittyri 2015-03-29 19:04
        
        to exclude or not to exclude - let the user decide yjlee168 2015-03-30 11:28
        
        to exclude or not to exclude - let the user decide ElMaestro 2015-03-30 15:44
        
        to exclude or not to exclude - let the user decide yjlee168 2015-03-31 11:15
        
        Constraints, algebra, jommetry and such ElMaestro 2015-03-31 12:16
        
        Constraints, algebra, jommetry and such yjlee168 2015-03-31 13:13
        
        Constraints, algebra, jommetry and such ElMaestro 2015-03-31 14:26
        
        Constraints, algebra, jommetry and such mittyri 2015-04-01 08:25
        
        Proc GLM, lm() do not auto-exclude subjects d_labes 2015-04-01 09:15
        
        Proc GLM, lm() do not auto-exclude subjects ElMaestro 2015-04-01 16:29

EMA oracle Helmut 2015-01-27 16:27
- EMA oracle nobody 2015-01-27 17:07
- Personal opinion ElMaestro 2015-01-27 17:56
- EMA oracle d_labes 2015-01-27 19:44
  - EMA oracle nobody 2015-01-28 09:04
    - EMA oracle ElMaestro 2015-01-28 13:11
- Response from Alfredo García-Arieta Helmut 2015-01-30 10:55
  - Response from Alfredo García-Arieta nobody 2015-01-30 14:55
    - Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 01:35
      - Wonnemann’s Figure 4 on steroids nobody 2015-02-01 11:18
        
        Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 14:49
      - General remarks ElMaestro 2015-02-01 18:43
        
        General remarks nobody 2015-02-01 22:04
        General remarks Helmut 2015-02-02 00:48
        
        General remarks nobody 2015-02-02 08:09
        
        General remarks Helmut 2015-02-02 14:06
        
        TIE: questions mittyri 2015-02-03 12:44
        
        TIE: questions Helmut 2015-02-03 13:24
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 12:02
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 12:22
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 13:07
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 13:41
- New Zealand nobody 2015-01-31 11:25
  - New Zealand Helmut 2015-02-01 16:08
    - New Zealand nobody 2015-02-01 22:08
      - New Zealand Helmut 2015-02-01 23:54
        
        New Zealand nobody 2015-02-02 08:07

Partial Replicate with Groups MGR 2015-02-03 09:46
- Partial Replicate with Groups Helmut 2015-02-03 10:54

pilot replicate design khaoula 2014-11-19 12:00
- pilot replicate design ElMaestro 2014-11-19 12:38
  - pilot replicate design khaoula 2014-11-19 14:11
    - N=24?? ElMaestro 2014-11-19 14:29
    - pilot replicate design Helmut 2014-11-19 15:18
      - pilot replicate design khaoula 2014-11-19 15:57
        
        Futile… Helmut 2014-11-20 14:39
        
        new information khaoula 2014-11-21 12:19
        kinetica khaoula 2014-11-22 10:38
        
        kinetica Helmut 2014-11-22 12:43

Case Study (FDA) Helmut 2014-09-30 13:02
- Case Study (FDA) jag009 2014-09-30 17:25
  - Case Study (FDA) Helmut 2014-09-30 20:09
    - Case Study (FDA) luvblooms 2014-10-01 06:24
      - Case Study (FDA) Helmut 2014-10-01 14:32
  - Case Study (FDA) luvblooms 2014-10-01 06:15
    - Case Study (FDA) jag009 2014-10-01 20:41

EMA: α-inflation – the suspicion begins to mount Helmut 2014-07-21 02:04
- EMA: α-inflation – the suspicion begins to mount ElMaestro 2014-07-21 09:24
  - Why simulate a simple AB|BA at all? Helmut 2014-07-21 16:14
    - Why simulate a simple AB|BA at all? ElMaestro 2014-07-21 20:50
      - Fancy smoothing? Helmut 2014-07-21 23:13
        
        Arbitrary smoothing? d_labes 2014-07-22 08:43
        
        Noise… Helmut 2014-07-22 13:31
        
        TSD Japonica… d_labes 2014-07-22 16:06
        
        TSD Japonica… Helmut 2014-07-22 17:50
        
        Noise debugged d_labes 2014-07-24 13:47
        
        Noise debugged Helmut 2014-07-24 15:07
        
        Shit happens d_labes 2014-07-24 16:09
      - Commentary d_labes 2014-07-22 08:18
        
        Commentary nobody 2014-09-15 08:24
        
        Commentary Helmut 2014-09-15 10:12
      - IBE/PBE = Two-Stage Helmut 2014-09-29 03:33
        
        IBE/PBE = Two-Stage ElMaestro 2014-09-29 15:16
        
        Sequential Design = Inflation likely… Helmut 2014-09-30 15:03

difficulty of understanding HVDPs khaoula 2014-09-08 15:01
- difficult to mee too ElMaestro 2014-09-08 15:47
- HVDs ≠ HVDPs Helmut 2014-09-13 18:49
  - HVDs ≠ HVDPs khaoula 2014-09-13 19:44

Model bioequivalence data summary tables-FDA kumarnaidu 2014-08-20 07:04
- FDA: 90% CI for RSABE Helmut 2014-08-20 10:44
  - FDA: 90% CI for RSABE kumarnaidu 2014-08-20 13:30
    - FDA: 90% CI for RSABE Helmut 2014-08-20 14:10
      - Not cast in stone jag009 2014-08-22 16:40
        
        Not cast in stone nobody 2014-08-22 17:17
        
        Not cast in stone jag009 2014-08-23 06:21

HVDP RSABE (FDA) and ABEL (EMA) khaoula 2014-05-20 19:18
- HVDP RSABE (FDA) and ABEL (EMA) d_labes 2014-05-22 14:24
  - HVDP RSABE (FDA) and ABEL (EMA) khaoula 2014-05-23 15:37
    - Some hints Helmut 2014-05-23 17:11
      - Some hints ElMaestro 2014-05-23 18:34
        
        Maths dummy Helmut 2014-05-23 23:44
      - Some hints khaoula 2014-05-23 20:56

Zero concentrations – all samples – full replicate pash413 2014-04-05 14:56
- Zero concentrations – all samples – full replicate ElMaestro 2014-04-05 20:17
- Zero concentrations – all samples – full replicate luvblooms 2014-04-07 07:47
  - serious risk to public health Dr_Dan 2014-04-07 08:35
  - Zero concentrations – all samples – full replicate pash413 2014-04-07 08:37
    - Zero concentrations – all samples – full replicate Helmut 2014-04-07 09:01
      - Zero concentrations – all samples – full replicate pash413 2014-04-07 09:30
        
        Imputation and BE/TE ElMaestro 2014-04-07 12:14
      - Zero concentrations – all samples – full replicate nobody 2014-04-07 09:31
    - Zero concentrations – all samples – full replicate luvblooms 2014-04-07 11:50
      - Zero concentrations – all samples – full replicate Mahesh M 2014-04-07 12:23
      - Zero concentrations – all samples – full replicate jag009 2014-04-07 16:18
    - Zero concentrations – all samples – full replicate jag009 2014-04-07 15:29
- Stability ? Ohlbe 2014-04-07 18:23
  - Stability ? Helmut 2014-04-07 19:39
    - Stability ? pash413 2014-04-09 13:00
      - Stability ? Mahesh M 2014-04-09 14:51
      - Stability ? Ohlbe 2014-04-09 16:31

Reference-scaled Bioequivalence AngusMcLean 2014-03-28 17:48
- scABE - implied limits d_labes 2014-03-31 11:16

Narrow therapeutic index drug Mahesh M 2014-01-02 10:32
- FDA: NTID-RSABE Helmut 2014-01-02 13:20

Partial replicate design Silva 2013-12-31 12:17
- extra-reference design Helmut 2013-12-31 14:28

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