Bioequivalence and Bioavailability Forum

Estimate the sample size HVD Yura 2020-12-03 08:47
- AUC (by ABE) and Cmax (by ABEL): power Helmut 2020-12-03 12:34
  - AUC (by ABE) and Cmax (by ABEL): power Yura 2020-12-04 08:11

Is Cmax 95% Upper bound 0.0024 = Zero? Sereng 2020-10-22 20:30
- 0.0024 > 0 ■ Helmut 2020-10-22 23:56
  - 0.0024 > 0 ■ jag009 2020-10-23 07:06

ABEL: Type I Error Helmut 2020-09-28 17:12
- Wow! d_labes 2020-09-28 17:51
- ABEL: Type I Error ElMaestro 2020-09-29 10:41
  - Lost in translation Helmut 2020-09-29 10:49

Partial replicate design: reference(s)? Helmut 2020-08-13 14:22
- Partial replicate design: reference(s)? ElMaestro 2020-08-13 15:23
  - Partial replicate design: reference(s)? Helmut 2020-08-13 17:03
- Hyslop's Alternative Cross-over Designs for Individual Bioequivalence mittyri 2020-08-13 16:21
  - Terry’s homebrew Helmut 2020-08-13 17:08
    - impressive homebrew mittyri 2020-08-13 18:09
      - impressive indeed Helmut 2020-08-14 13:21
- Partial replicate design: reference(s)? zizou 2020-08-13 23:24
  - Donald’s model Helmut 2020-08-14 11:43
    - Donald’s model - model for (logistic) groups d_labes 2020-08-14 14:03
      - Donald’s model - model for (logistic) groups Helmut 2020-08-14 14:06
- Interlude I (sample sizes, problems & remedies) Helmut 2020-08-14 19:37
- Interlude II (simulations) Helmut 2020-08-19 21:31
  - Interlude II (simulations) PharmCat 2020-08-19 22:26

Ratio calculation of fully replicate study Mithu 2020-07-09 09:18
- Ratio calculation of fully replicate study Helmut 2020-07-09 10:51
  - Ratio calculation of fully replicate study Mithu 2020-07-09 11:23
    - Ratio calculation of fully replicate study Helmut 2020-07-09 12:19
      - Ratio calculation of fully replicate study Mithu 2020-07-09 12:46
        
        Purpose? Helmut 2020-07-09 13:10
        
        Purpose? Mithu 2020-07-09 13:22
        
        Purpose? Helmut 2020-07-09 13:56
        
        Purpose? jag009 2020-07-09 18:01
        Purpose? Mithu 2020-07-10 08:00

Missing periods in replicate designs Helmut 2019-10-16 13:14
- Missing periods in replicate designs ElMaestro 2019-10-16 15:10
  - Missing samples Helmut 2019-10-17 10:22
    - Missing ambulatory samples M.tareq 2020-04-09 15:24
      - Missing ambulatory samples Helmut 2020-04-09 16:15
        
        Missing ambulatory samples M.tareq 2020-04-09 16:54
- Missing periods in replicate designs d_labes 2019-10-17 17:22
  - Missing periods in replicate designs ElMaestro 2019-10-17 20:17
    - Missing periods in replicate designs d_labes 2019-10-18 11:48
  - Missing periods in replicate designs Helmut 2019-10-19 14:30
    - Missing periods in replicate designs: save the data? Astea 2019-10-20 14:46
      - Missing periods in replicate designs: save the data? Helmut 2019-10-20 15:23
        
        Missing periods in replicate designs: kill the data? Astea 2019-10-21 01:59
        
        Meaningful data? Helmut 2019-10-21 11:37
- Missing periods in replicate designs Mahmoud 2019-11-06 11:41
  - Kenward-Roger? Helmut 2019-11-06 12:49
    - Kenward-Roger? PharmCat 2019-11-06 14:43
      - Kenward-Roger ≥ Satterthwaite Helmut 2019-11-08 20:57
        
        Kenward-Roger ≥ Satterthwaite PharmCat 2019-11-08 22:08
      - Kenward-Roger - links mittyri 2019-11-08 22:59
        
        Kenward-Roger - links PharmCat 2019-11-09 00:51
        degrees of freedom Helmut 2019-11-09 16:22
        
        degrees of freedom PharmCat 2019-11-09 19:11

Statistical evaluation and BE hypotheses in full replicate design Elena777 2020-01-28 07:02
- Inflation of the TIE as well Helmut 2020-01-29 15:38
  - Inflation of the TIE as well Elena777 2020-01-29 20:01
    - Tricky… Helmut 2020-01-30 12:07
      - Tricky… Mikalai 2020-01-30 13:08
        
        Terrible… Helmut 2020-01-30 15:09
        
        Tricky… Mikalai 2020-01-30 16:02
        
        Deep shit Helmut 2020-01-30 16:59
        
        Deep shit Mikalai 2020-01-30 18:39
        
        Deep shit Mikalai 2020-01-30 19:31
        Deep shit Helmut 2020-01-30 20:07
        
        Deep shit Mikalai 2020-01-31 11:14
        
        Deep shit Helmut 2020-01-31 14:00
        
        Deep shit Mikalai 2020-01-31 16:07
        
        Flawed evaluation accepted Helmut 2020-01-31 12:19
        
        Flawed evaluation accepted Mikalai 2020-01-31 12:40
        
        Flawed evaluation accepted Helmut 2020-01-31 14:17
        
        Flawed evaluation accepted Mikalai 2020-01-31 16:41
        
        Flawed approach even if accepted ? Helmut 2020-01-31 20:28
        
        Flawed approach even if accepted ? Mikalai 2020-02-01 16:18
        
        misunderstanding mittyri 2020-02-01 21:34
        
        misunderstanding Mikalai 2020-02-06 13:41
        
        misunderstanding mittyri 2020-02-06 16:23
        
        The globe is flat! d_labes 2020-02-05 19:16
      - Tricky… wienui 2020-01-30 18:53
        
        Tricky… Helmut 2020-01-30 19:18
        
        Tricky… wienui 2020-02-03 07:10
        
        ABE vs. ABEL Helmut 2020-02-03 12:25
        
        zigzag d_labes 2020-02-05 18:53
        
        zigzag Helmut 2020-02-05 19:46
        
        zigzag Mikalai 2020-02-06 11:38
        
        helter-skelter Helmut 2020-02-06 20:12
        
        helter-skelter Mikalai 2020-02-10 16:10
  - Inflation of the TIE as well zizou 2020-02-01 17:00
    - Inflation of the TIE as well nobody 2020-02-01 23:30
  - Inflation of the TIE as well Elena777 2020-03-10 19:28
    - Fishing in the dark Helmut 2020-03-10 21:06
- Statistical evaluation and BE hypotheses in full replicate design nobody 2020-02-03 15:07
  - TIE, repeat once more please... Astea 2020-04-02 12:41

To Russia (with love?) Helmut 2019-12-04 01:21
- To Russia (with love?) Astea 2019-12-04 07:40
  - From Russia (with love?) Helmut 2019-12-04 10:58
    - From Russia with review mittyri 2019-12-04 11:29
    - From Russia (with love?) PharmCat 2019-12-04 15:16
      - Ignorance is not bliss Helmut 2019-12-04 17:16
        
        Ignorance is not bliss nobody 2019-12-04 18:12
        Ignorance is not bliss - but this is modus vivendi PharmCat 2019-12-04 18:12
        Ignorance is Strength? Astea 2019-12-04 18:15
        
        So sad! Helmut 2019-12-04 19:15
        does existence exist? PharmCat 2019-12-05 11:09
        
        OT: Something and nothing Helmut 2019-12-06 10:37
        
        add OT: Everything and Nothing Astea 2019-12-06 11:52
        OT: Something and nothing Russian edition mittyri 2019-12-06 12:04
        
        OT: Something and nothing Russian edition nobody 2019-12-06 21:33
        
        OT: “Deutscher Humor” Helmut 2019-12-07 20:11
        
        OT: “Deutscher Humor” nobody 2019-12-07 20:30
        
        OT: “Deutscher Humor” Helmut 2019-12-07 20:42
        
        OT: “Deutscher Humor” nobody 2019-12-07 21:21
        
        OT: Something and nothing PharmCat 2019-12-06 23:26

FDA's HVD SAS Code from Progesterone Guidance jag009 2013-04-22 16:39
- Proc MIXED vs. Proc GLM Helmut 2013-04-22 17:47
  - Proc MIXED vs. Proc GLM jag009 2013-04-22 20:33
    - SAS vs. PHX Helmut 2013-04-22 22:10
      - SAS vs. PHX Shuanghe 2013-04-23 11:45
        
        SAS vs. SAS d_labes 2013-04-23 16:50
        
        SAS vs. SAS vs. Phoenix Helmut 2019-11-12 13:01
      - SAS vs. PHX jag009 2013-04-23 15:56
        
        SAS Warning (Note) on Proc Mixed jag009 2013-04-23 17:07
        
        Nut Job.. jag009 2013-04-30 21:09
        
        Second opinion (PHX 6.3) Helmut 2013-05-01 16:21
        
        Second opinion (PHX 6.3) jag009 2013-05-01 17:16
        
        Second opinion (PHX 6.3) ElMaestro 2013-05-01 18:48
        In praise of a full replicate Helmut 2013-05-01 19:16
        Third opinion d_labes 2013-05-02 12:00
        
        Compound Symmetry Helmut 2013-05-02 14:41
        
        Compound Symmetry - SASian (1) d_labes 2013-05-02 16:26
        
        Variance=0 Helmut 2013-05-03 16:07

Inflation type one error Mikalai 2019-11-05 18:59
- Inflation type one error Helmut 2019-11-05 22:50
  - Inflation type one error Mikalai 2019-11-06 15:13
    - Inflation type one error Helmut 2019-11-08 14:52
    - Inflation type one error: FDA Helmut 2019-11-10 11:33
- Inflation type one error PharmCat 2019-11-05 23:06
  - Inflation type one error Helmut 2019-11-08 15:21
    - Inflation type one error PharmCat 2019-11-08 18:15
      - TIE = chance of passing at the border(s) Helmut 2019-11-08 20:26

subject inclusion question in replicate design for ANVISA Shuanghe 2019-09-04 14:48
- subject inclusion question in replicate design for ANVISA Helmut 2019-09-04 20:23
  - subject inclusion question in replicate design for ANVISA Shuanghe 2019-09-05 14:38

REML, ML and MM different BE decision M.tareq 2019-07-21 19:09
- REML, ML and MM different BE decision Helmut 2019-07-22 17:19

East African Community: ABEL Helmut 2019-05-20 19:58

FDA: RSABE for NTID Jay 2018-03-26 13:31
- FDA: RSABE for NTID jag009 2018-03-26 17:57
  - FDA: RSABE for NTID Jay 2018-04-02 06:28
    - FDA: RSABE for NTID pjs 2018-04-02 15:07
      - FDA: RSABE for NTID Jay 2018-04-04 14:24
        
        β = 1 – π Helmut 2018-04-04 15:03
        
        Warfarin Sodium 95% Upper bound criteria Nirali 2019-01-30 15:38
        
        Upper bound in RSABE ≤0 Helmut 2019-02-02 14:15
        
        Upper bound in RSABE ≤0 Nirali 2019-02-12 07:10

Ratio % in ABE vs. Point Estimate in RSABE Ahikal 2019-01-27 17:49
- Specify the question mittyri 2019-01-28 14:23
  - Specify the question Ahikal 2019-01-29 08:58
    - 3b vs ABE PE FDA RSABE mittyri 2019-02-02 13:17
    - Data? Helmut 2019-02-02 13:31