Bioequivalence and Bioavailability Forum

Two PK metrics: Inflation of the Type I Error Helmut 2017-11-12 11:57
- Two PK metrics: Inflation of the Type I Error? d_labes 2017-11-12 17:46
- A place to start ElMaestro 2017-11-12 21:43
  - A place to start? d_labes 2017-11-13 16:02
    - A place to start? Helmut 2017-11-13 16:51
      - Scientific gut feeling d_labes 2017-11-15 10:34
        
        Five minutes gone - power.tsd.2m() arose d_labes 2017-11-15 13:15
    - A better place to start. ElMaestro 2017-11-14 00:04
      - Nope Helmut 2017-11-14 00:21
        
        Nope nobody 2017-11-14 08:11
        I've meditated hard ElMaestro 2017-11-14 12:41

Potvin designs w. imbalance - what would you expect? ElMaestro 2017-08-17 13:02
- Dropouts in stage 2 Helmut 2017-09-12 01:41
- Dropouts continued Helmut 2017-09-19 17:17

Initial sample size guess for the Potvin methods ElMaestro 2017-08-19 15:04
- Initial sample size guess for the Potvin methods Helmut 2017-08-19 16:06
  - Initial sample size guess for the Potvin methods ElMaestro 2017-08-19 16:14
    - Initial sample size guess for the Potvin methods Helmut 2017-08-19 17:12
      - Initial sample size guess for the Potvin methods ElMaestro 2017-08-19 17:17
        
        Confuse-a-Cat Helmut 2017-08-19 17:33
        
        Confuse-a-Cat ElMaestro 2017-08-19 17:56
    - loop ↔ vectorized ↔ direct Helmut 2017-08-20 14:40
      - loop ↔ vectorized ↔ direct ElMaestro 2017-08-20 15:22
        
        loop ↔ vectorized ↔ direct Helmut 2017-08-20 16:23
        
        loop ↔ vectorized ↔ direct ElMaestro 2017-08-20 17:22
- The n ext crackpot iteration ElMaestro 2017-08-19 20:04
  - The n ext crackpot iteration Helmut 2017-08-20 02:20
- The ultimate crackpot iteration! ElMaestro 2017-08-20 14:35
  - The ultimate crackpot iteration! Helmut 2017-08-20 15:11
    - The ultimate crackpot iteration! ElMaestro 2017-08-20 15:28
      - The ultimate crackpot iteration! Helmut 2017-08-20 16:06
        
        The ultimate crackpot iteration! ElMaestro 2017-08-20 16:15
        
        The ultimate crackpot iteration! Helmut 2017-08-20 18:58
        
        The ultimate crackpot iteration! ElMaestro 2017-08-20 19:32
        
        Suggested code ElMaestro 2017-08-21 18:13
        
        Nitpicker! Helmut 2017-08-22 13:33
        
        Nitpicker! ElMaestro 2017-08-22 17:27
        
        Nitpicker! Helmut 2017-08-22 17:49
        
        Nitpicker! ElMaestro 2017-08-22 17:59
        
        Nitpicker! Helmut 2017-08-22 19:15
        
        Benchmark code ElMaestro 2017-08-22 22:29
        
        Benchmark code Helmut 2017-08-23 01:48

Potvin C in the EU Helmut 2013-04-16 17:40
- Potvin C in the EU ElMaestro 2013-04-17 02:31
  - Potvin C in the EU Helmut 2013-04-17 12:23
    - 2 Groups model FDA d_labes 2013-04-17 13:10
      - 2 Groups model FDA Helmut 2013-04-17 16:37
        
        Group effects obsolete? d_labes 2013-04-18 09:55
        
        Group effects FDA/EMA Helmut 2013-04-19 14:34
        
        Group effects FDA/EMA mittyri 2014-08-21 15:34
        
        Group effects FDA/EMA ElMaestro 2014-08-21 17:31
        
        Group effects EMA mittyri 2014-10-01 11:25
        
        Group effects EMA ElMaestro 2014-10-01 11:31
        Group effects EMA Helmut 2014-10-01 13:24
        
        Group effects EMA VStus 2016-10-06 22:06
        
        Group effects EMA ElMaestro 2016-10-07 12:45
        
        Group effects EMA mittyri 2016-10-07 15:06
        
        Fixed effects model with Group term mittyri 2016-10-09 13:27
        
        Fixed effects model: changing the F, p values mittyri 2016-10-10 18:33
        
        Fixed effects model: changing the F, p values ElMaestro 2016-10-10 20:10
        
        Fixed effects model: changing the F, p values Helmut 2016-10-11 00:17
        Holy War of type III d_labes 2016-10-11 13:17
        
        Significance of Group effect in Russia: why the type III is so 'important' mittyri 2016-10-11 15:07
        
        Fixed effects model: changing the F, p values zizou 2016-10-11 01:06
        
        FDA group model in R mittyri 2016-10-11 13:43
        
        FDA group model in R ElMaestro 2016-10-12 01:07
        FDA group model in R VStus 2016-10-17 15:32
        
        FDA group model in R ElMaestro 2016-10-17 18:58
        
        FDA group model in R VStus 2016-10-20 13:57
        
        Fixed effects model with Group term VStus 2016-10-20 13:54
        
        Group effects FDA/EMA zizou 2016-12-31 02:54
        
        Group effects FDA/EMA Helmut 2017-06-03 14:57
        
        2 Groups model FDA hiren379 2013-08-22 14:32
        
        Homework Helmut 2013-08-23 11:53

Data for 2nd stage of Potvin’s designs BE-proff 2017-02-18 06:40
- Data for 2nd stage of Potvin’s designs ElMaestro 2017-02-18 10:20
  - Data for 2nd stage of Potvin’s designs BE-proff 2017-02-18 13:29
    - GMR = fixed! Helmut 2017-02-18 16:23
- “Type 1” slightly higher power than “Type 2” for the same adj. α Helmut 2017-02-18 11:51
  - “Type 1” slightly higher power than “Type 2” for the same adj. α BE-proff 2017-02-18 13:31
    - Terminology Helmut 2017-02-18 16:27
      - Terminology Yura 2017-02-20 11:28
        
        Which GMR to plug in ElMaestro 2017-02-20 11:46
        
        Which GMR to plug in BE-proff 2017-02-21 11:35
        
        Which GMR to plug in ElMaestro 2017-02-21 11:47
        
        Validated frameworks; observed GMR not relevant Helmut 2017-02-22 12:03
        
        Validated frameworks; observed GMR not relevant Silva 2017-03-09 01:26
        
        GMR, theta 0 and that all d_labes 2017-03-09 09:21
        
        GMR, theta 0 and that all Silva 2017-03-09 12:38
        
        GMR, theta 0 and that all ElMaestro 2017-03-09 12:56
        GMR, theta0 and that all d_labes 2017-03-09 13:55
        
        GMR, theta0 and that all Silva 2017-03-09 18:01
  - “Type 1” slightly higher power than “Type 2” for the same adj. α BE-proff 2017-02-21 11:31

Impact of minimum stage 2 sample size on the Type I Error Helmut 2016-12-30 01:22
- Impact of minimum stage 2 sample size on the Type I Error ElMaestro 2016-12-30 12:12
  - Impact of minimum stage 2 sample size on the TIE: example Helmut 2016-12-30 14:01
    - Impact of minimum stage 2 sample size on the TIE: example ElMaestro 2016-12-30 17:19
      - Impact of minimum stage 2 sample size on the TIE: example Helmut 2016-12-30 18:00
        
        Impact of minimum stage 2 sample size on the TIE: example ElMaestro 2016-12-30 18:50
        
        Bingo! Helmut 2016-12-30 19:00

Inflation of the TIE with Xu’s ‘Method F’? Helmut 2016-12-25 01:49
- Inflation of the TIE with Xu’s ‘Method F’? d_labes 2016-12-27 11:09
  - Inflation of the TIE with Xu’s ‘Method F’? ElMaestro 2016-12-27 11:43

Replicated 4×2 and two-stage-design, in the same protocol Mauricio Sampaio 2015-04-06 08:37
- Replicated 4×2 and two-stage-design, in the same protocol ElMaestro 2015-04-06 08:53
- Science fiction Helmut 2015-04-06 14:20
  - Science fiction Dr_Dan 2016-03-04 10:33
    - Science fiction furthermore d_labes 2016-03-04 13:21
    - Still SF Helmut 2016-03-04 13:41
      - Still SF VStus 2016-10-06 21:08
        
        Still SF ElMaestro 2016-10-06 22:13
        
        Still SF VStus 2016-10-06 22:53
        Still SF VStus 2016-10-11 10:23
        
        Still SF Helmut 2016-10-07 10:38
        
        Still SF VStus 2016-10-11 09:10
- mindblowing ElMaestro 2016-10-11 07:44
  - Natural constant as usual; not for reference-scaling Helmut 2016-10-11 09:50
    - Consistency DavidManteigas 2016-10-11 11:25

TSD: CIs for different analytes and metrics mittyri 2016-06-04 21:39

The EMA’s BSWP’s opinon Helmut 2016-03-04 15:37
- The EMA’s BSWP’s opinon ElMaestro 2016-03-04 23:16
  - Control of the TIE (empiric via simulations vs. proof) Helmut 2016-03-05 15:17
    - To whom it may concern ElMaestro 2016-03-06 22:59
      - To whom it may concern d_labes 2016-03-07 11:41
- Opinon? d_labes 2016-03-06 13:31
  - Obsession? Helmut 2016-03-06 14:45
    - Obsession? DavidManteigas 2016-06-02 12:57
      - 0.0501 not acceptable Helmut 2016-06-02 13:30
        
        OT: Guernsey McPearson's Drug Development Dictionary d_labes 2016-06-02 14:44
        
        OT: Comparison Helmut 2016-06-02 15:59
        
        OT: Comparison d_labes 2016-06-02 16:42

Adaptive TSD vs. “classical” GSD Helmut 2015-11-27 19:05
- Adaptive TSD vs. “classical” GSD ElMaestro 2015-11-27 19:54
- “classical” GSD - E[n] d_labes 2015-11-30 11:15
  - Apples are pears by comparing the weight Helmut 2015-12-01 16:35
    - Apples are pears by comparing the weight d_labes 2015-12-03 09:16
      - Apples are pears by comparing the weight Helmut 2015-12-03 13:10
        
        Oranges d_labes 2015-12-03 13:56
- Adaptive TSD vs. “classical” GSD Ben 2015-12-02 19:27
  - Adaptive TSD vs. “classical” GSD Helmut 2015-12-03 03:11
    - “classical” GSD alpha's d_labes 2015-12-03 09:47
      - N sufficiently large‽ Helmut 2015-12-03 14:56
        
        An other one with 0.0304 d_labes 2015-12-03 16:15
        
        An other one with 0.0304 Helmut 2015-12-03 16:26
    - Adaptive TSD vs. “classical” GSD Ben 2016-01-10 12:43

Letteritis: Method E & F d_labes 2015-12-17 14:27

futility design Ghannam86 2015-12-16 23:43
- futility design ElMaestro 2015-12-16 23:49
  - OT Helmut 2015-12-17 00:06
  - futility design Ghannam86 2015-12-17 00:10
    - α [0, 0.05] Helmut 2015-12-17 00:35
    - futility design = SSR ? d_labes 2015-12-17 08:49
      - futility design = SSR ? nobody 2015-12-17 11:01
        
        OT dark universe d_labes 2015-12-17 12:52

Sequential trial with B method of Potvin john john 2015-10-01 17:44
- Sequential trial with B method of Potvin ElMaestro 2015-10-01 17:58
- Sequential trial with B method of Potvin Helmut 2015-10-01 18:13
  - Sequential trial with B method of Potvin john john 2015-10-07 11:26
    - Power to the people d_labes 2015-10-07 13:49
      - Power to the people john john 2015-10-07 14:54
        
        Software? Ethics beyond statistics… Helmut 2015-10-07 16:06
        
        Subtraction of a df ElMaestro 2015-10-07 21:22
        
        df = df-1 d_labes 2015-10-08 08:10
    - Potvin B: α 0.0294 in both stages Helmut 2015-10-08 15:27
      - Potvin B: α 0.0294 in both stages john john 2015-10-23 12:04

BA/BE Studies for Early Termination balakotu 2015-09-22 13:05
- BA/BE Studies for Early Termination ElMaestro 2015-09-22 13:35
- Dose subjects but not using them d_labes 2015-09-22 13:49
- IMHO, that’s a TSD… Helmut 2015-09-22 13:58