Bioequivalence and Bioavailability Forum

Two-stage design Regulatory Mikkabel 2020-06-23 17:42
- EMA: TSDs Helmut 2020-06-23 18:22

ANVISA guidelines for two-stage design Mauricio Sampaio 2020-02-11 20:52
- Brainless copy-and-paste-devil Helmut 2020-02-12 02:26
  - Brainless copy-and-paste-devil Mauricio Sampaio 2020-02-12 17:33
- ANVISA guidelines for two-stage design ElMaestro 2020-02-12 08:27
  - ANVISA guidelines for two-stage design nobody 2020-02-12 08:49
  - ANVISA guidelines for two-stage design Helmut 2020-02-12 13:12
  - ANVISA guidelines for two-stage design Mauricio Sampaio 2020-02-12 17:04
  - ANVISA guidelines for two-stage design Mauricio Sampaio 2020-02-12 17:11
- ANVISA guidelines for two-stage design ElMaestro 2020-02-12 21:54
  - crap Helmut 2020-02-15 17:53
    - crap Mauricio Sampaio 2020-02-16 05:01
      - crap Helmut 2020-02-16 15:43
        
        crap d_labes 2020-02-16 19:34
        
        Explained crap remains crap Helmut 2020-02-17 12:49
        
        Proposed changes Mauricio Sampaio 2020-02-17 13:50
        
        Proposed changes Helmut 2020-02-17 14:16

EU, method C preference ElMaestro 2019-10-11 10:25
- On the contrary, my dear Dr Watson! Helmut 2019-10-11 11:52
  - On the contrary, my dear Dr Watson! nobody 2019-10-11 17:39
    - On the contrary, my dear Dr Watson! Helmut 2019-10-11 17:47
      - On the contrary, my dear Dr Watson! ElMaestro 2019-10-11 18:01
        
        On the contrary, my dear Dr Watson! nobody 2019-10-11 18:08
        On the contrary, my dear Dr Watson! Helmut 2019-10-11 18:11
- EU: simulation-based methods in agony Helmut 2019-10-19 12:38
  - EU: ABEL TIE?? mittyri 2019-10-19 23:24
    - Reference-scaling: only simulations possible Helmut 2019-10-20 13:58

Appropriate wording for a protocol Elena777 2019-09-09 19:34
- Appropriate wording for a protocol ElMaestro 2019-09-09 21:39
  - Appropriate wording for a protocol Helmut 2019-09-09 23:27
  - Appropriate wording for a protocol Ohlbe 2019-09-10 10:27
- Which country? Helmut 2019-09-09 23:17
  - Which country? Elena777 2019-09-11 20:24
    - EEU-rules, TSD-methods (lengthy answer) Helmut 2019-09-12 01:31
      - EEU-rules, TSD-methods (lengthy question) Astea 2019-09-14 14:56
        
        n2 based on PK metric with higher CV Helmut 2019-09-16 11:50
        
        Q&A ref Astea 2019-09-16 18:28
        
        The omniscient oracle has spoken Helmut 2019-09-17 12:27
        
        The omniscient oracle has spoken Astea 2019-09-17 20:34
        
        OT: Булга́ков Helmut 2019-09-18 12:12
        
        n2 based on PK metric with higher CV Elena777 2019-09-16 19:48
        
        AUC passes with 0.05 and Cmax with 0.0294 Helmut 2019-09-16 23:30
        
        AUC passes with 0.05 and Cmax with 0.0294 Mikalai 2019-09-18 16:56
        
        Hybrid B/C Helmut 2019-09-18 17:09
        
        AUC passes with 0.05 and Cmax with 0.0294 Elena777 2019-09-19 08:34
        
        Use data of all dosed subjects Helmut 2019-09-19 15:16
        
        Use data of all dosed subjects Elena777 2019-09-19 15:27
        
        ‘Method C’ ⇒ risky Helmut 2019-09-19 16:15
        
        EEU-rules, TSD-methods (lengthy question) Elena777 2019-09-16 19:35
        
        apple tree for two-stage Astea 2019-09-16 20:39
        
        overripe apples Helmut 2019-09-16 23:37
        
        override apples Astea 2019-09-17 06:14

Two-Stage Design for FDC Astea 2019-06-06 01:24
- No simple way out mittyri 2019-06-08 15:44
  - the more complicated the more interesting Astea 2019-06-09 22:56

2-stage design with interim sample size estimation d_labes 2010-10-05 15:09
- 2-stage design with interim sample size estimation Jack 2010-10-25 18:20
  - Null = bioINequivalence Helmut 2010-10-25 19:16
  - 2-stage design with interim sample size estimation d_labes 2010-10-26 13:28
    - 2-stage design with interim sample size estimation Jack 2010-10-26 18:26
      - Blind or not, Indecisions or Decisions d_labes 2010-10-27 16:01
        
        Blind or not, Indecisions or Decisions Jack 2010-10-27 18:14
        
        Blind ? Ohlbe 2010-10-27 23:37
        
        Blind ? Jack 2010-10-28 10:24
        
        Blind 2Stage Astea 2019-05-30 10:37
        
        Blind 2Stage Helmut 2019-05-30 12:56
        
        Blind 2Stage and an elephant Astea 2019-05-31 14:36
        
        Which elephant? Helmut 2019-06-02 20:14
        
        Blind interim in parallel design? Astea 2019-06-03 01:47
        
        Blind men d_labes 2019-06-05 12:23
        
        The Blind Leading the Blind Astea 2019-06-06 00:55

Finally: Exact TSD methods for 2×2 crossover designs Helmut 2018-04-21 17:17
- Exact TSD methods: Example Helmut 2018-04-21 20:33
- Finally: Exact TSD methods for 2×2 crossover designs ElMaestro 2018-04-21 20:49
  - Flow chart (without details) Helmut 2018-04-21 21:41
    - naive questions regarding new functions in Power2Stage mittyri 2018-04-28 15:54
      - Some answers Helmut 2018-04-28 17:29
      - Some more "answers" d_labes 2018-04-29 21:11
        
        clarification regarding user Power2Stage guides mittyri 2018-04-30 13:41
- Technicality: Weigths for the inverse normal approach d_labes 2018-04-25 14:19
  - Selection of w and w* Helmut 2018-04-26 09:51
    - Selection of w and w* d_labes 2018-04-26 20:02
    - Now what? w & w* examples d_labes 2018-05-09 13:53
      - Now what? w & w* examples Ben 2018-06-10 20:12
        
        Now what? w & w* examples Helmut 2018-06-11 13:57
        
        Now what? w & w* examples Ben 2018-06-12 19:14
        
        a bug in interim.tsd.in()? mittyri 2018-06-11 23:27
        
        a bug in interim.tsd.in()? Ben 2018-06-12 19:32
        
        Nonbinding futility rule d_labes 2018-06-13 16:59
        
        Bad weather? Helmut 2018-06-13 19:23
        
        NLYW? d_labes 2018-06-14 10:18
        
        Nonbinding futility rule Ben 2018-06-13 20:26
        
        Nonbinding futility rule d_labes 2018-06-14 10:47
        
        Nonbinding futility rule Ben 2018-06-15 17:58
        
        Binding / Nonbinding futility rule - alpha control d_labes 2018-06-16 19:42
        
        Binding / Nonbinding futility rule - alpha control Ben 2019-03-30 09:52

Two-stage design and 'forced bioequivalence' Mikalai 2018-06-06 08:28
- Two-stage design and 'forced bioequivalence' ElMaestro 2018-06-06 10:53
  - Two-stage design and 'forced bioequivalence' Yura 2018-06-07 10:24
    - But what is the real problem? ElMaestro 2018-06-07 13:53
      - But what is the real problem? Yura 2018-06-07 14:59
        
        But what is the real problem? Mikalai 2018-06-07 15:47
        
        But what is the real problem? Helmut 2018-06-07 17:33
        
        But what is the real problem? Mikalai 2018-06-08 12:24
        
        U as a futility criterion Helmut 2018-06-08 14:00

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