Bioequivalence and Bioavailability Forum

Simulation-based 2×2×2 TSDs – a deep dive Helmut 2024-09-03 13:18

A rant Helmut 2024-08-26 12:52
- A rant Achievwin 2024-08-28 02:16
  - Parallel (replicate?) Helmut 2024-08-28 10:54

Parallel Group Adaptive Designs Alex 2023-12-22 10:08
- Strong Type I Error control + CI: Not yet… Helmut 2023-12-22 12:01
  - Strong Type I Error control + CI: Not yet… Alex 2024-01-08 16:22
    - Strong Type I Error control + CI: Not yet… Helmut 2024-01-09 09:48
  - Strong Type I Error control + CI: Not yet… roman_max 2024-04-04 15:18
    - Parallel design: Only simulation-based methods so far Helmut 2024-04-04 20:16
      - Parallel design: Only simulation-based methods so far roman_max 2024-04-15 21:46
- Parallel Group Adaptive Designs Achievwin 2024-01-05 11:53
  - Simulations highly recommended Helmut 2024-01-05 12:40
    - Simulations highly recommended Achievwin 2024-01-08 16:55
      - Simulations mandatory Helmut 2024-01-09 09:31
        
        Simulations mandatory Achievwin 2024-01-09 21:11
        
        Reviews are confidential Helmut 2024-01-09 22:10
        
        Reviews are confidential Achievwin 2024-01-19 15:11
        
        Not accepted and for a reason… Helmut 2024-04-04 20:22
        
        Quod licet Iovi mittyri 2024-04-05 20:33
        
        Non licet bovi Helmut 2024-04-05 21:50
        
        Non licet bovi mittyri 2024-04-05 22:21
        
        Quod licet bove? Helmut 2024-04-06 07:21

Two-Stage Sequential Potvin Designs BEQool 2024-03-04 08:45
- TSD, GSD, Add-Ons, etc. Helmut 2024-03-05 13:56
- Two-Stage Sequential Potvin Designs ElMaestro 2024-03-05 20:51
  - Two-Stage Sequential Potvin Designs BEQool 2024-03-10 10:11
    - Two-Stage Sequential Potvin Designs ElMaestro 2024-03-10 20:18
      - Too coarse grid? Helmut 2024-03-10 20:49
        
        Too coarse grid? ElMaestro 2024-03-10 21:06
        
        Balance… Helmut 2024-03-12 11:40
      - Two-Stage Sequential Potvin Designs BEQool 2024-03-11 20:45

Adaptive Design for the FDA’s RSABE? Helmut 2023-12-18 11:20
- Likely it does not work (potentially inflated Type I Error) Helmut 2023-12-19 11:10
  - Exploring package adaptIVPT, function rss() Helmut 2023-12-20 13:27
    - Extreme test case Helmut 2023-12-24 13:01
      - Extreme GMR Naksh 2023-12-25 04:16
        
        PE outside {0.80, 1.25} not possible Helmut 2023-12-25 10:54
        
        PE outside {0.80, 1.25} not possible Naksh 2023-12-25 11:42
        
        Forget rss() Helmut 2023-12-25 13:15
        
        Forget rss() Naksh 2023-12-26 04:49
        
        TSD useful at all? Helmut 2023-12-26 12:50

T1E after 1st stage in Power2Stage mittyri 2022-06-24 13:43
- T1E after 1st stage in TSDs Helmut 2022-06-24 14:33
  - T1E after 1st stage in TSDs mittyri 2022-06-24 21:12
    - T1E after 1st stage in TSDs Helmut 2022-06-25 14:07
      - Potvin C consequences mittyri 2022-06-25 23:29
        
        Potvin C consequences ElMaestro 2022-06-26 09:11
        
        Potvin C consequences mittyri 2022-06-27 13:45
        
        Potvin C consequences Helmut 2022-06-27 14:49
        
        from Potvin C to Inverse Normal mittyri 2022-06-27 17:13
        
        From Potvin C to Inverse Normal: history (and outlook?) Helmut 2022-06-27 18:54
        
        Potvin C consequences ElMaestro 2022-06-27 17:13
        
        true CV ≠ observed CV mittyri 2022-06-27 17:22
- T1E after 1st stage in Power2Stage ElMaestro 2022-06-24 18:25
  - T1E after 1st stage in Power2Stage mittyri 2022-06-24 21:05
    - T1E after 1st stage in Power2Stage ElMaestro 2022-06-24 22:55

Two Stage Desing: ANOVA earlybird 2009-10-16 11:25
- Potvin et al: effects in stage 2 Helmut 2009-10-16 13:32
  - Potvin et al: effects in stage 2 d_stat 2021-07-19 16:26
    - Forget simulation-based TSDs for 2×2×2 in Europe Helmut 2021-07-19 17:22
      - TSD statistical model - with multiple sites d_stat 2021-07-20 13:58
        
        TSD statistical model - with multiple sites Helmut 2021-07-20 21:52
        
        TSD statistical model - with multiple sites d_stat 2021-10-11 17:48
        
        TSD statistical model - with multiple sites Helmut 2021-10-12 11:27

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