Bioequivalence and Bioavailability Forum

Cross over BE study with four periods TAC_Sp 2014-04-04 13:39
- Cross over BE study with four periods Helmut 2014-04-04 14:20

Two Stage Design for EMEA prashantmohite 2014-03-29 06:39
- Two Stage Design for EMEA ElMaestro 2014-03-29 19:10
- Two Stage Design for EMA [sic] Helmut 2014-03-31 00:35
  - Two Stage Design for EMA [sic] prashantmohite 2014-04-01 06:20

Interim analysis report generation Tina 2014-01-02 09:33
- TSD? Helmut 2014-01-02 10:26
  - TSD? Tina 2014-01-03 17:41
    - TSD procedure Helmut 2014-01-04 14:41
    - R-code for balance Helmut 2014-01-04 22:36
      - R-code for balance Tina 2014-01-06 11:15
    - Fixed sample size? Helmut 2014-01-06 13:52

Acceptance by FDA/CDER Mahesh 2013-08-06 06:12
- Two stage BE design ElMaestro 2013-08-06 10:05
- Two stage BE design Helmut 2013-08-06 15:31
  - Two stage BE design Mahesh 2013-08-07 06:51
    - Two stage BE design kumarnaidu 2013-10-17 15:08
      - Two stage BE design ElMaestro 2013-10-17 17:28
        
        Two stage BE design kumarnaidu 2013-10-18 05:59
        
        EMA vs. rest of the world Helmut 2013-10-18 14:42
        
        Two stage BE design — cold water thrown on our head Shuanghe 2013-10-18 10:05
        
        Open your mouth and forcefully spit the water out Helmut 2013-10-18 13:29
        
        Change in statistical design kumarnaidu 2013-10-19 07:52
        
        Bad idea Helmut 2013-10-19 15:04
        
        Bad idea kumarnaidu 2013-10-21 06:01
        
        Change to Method B? Helmut 2013-10-21 14:51
        
        Change to Method B? kumarnaidu 2013-10-22 06:15
        
        Simulations Helmut 2013-10-22 13:20
        
        Open your mouth and forcefully spit the water out Shuanghe 2013-10-22 09:03
        
        Reach for the stars Helmut 2013-10-22 13:05
        
        Alpha inflation in two stage design kumarnaidu 2013-12-04 13:43
        
        Deficiency letters Helmut 2013-12-04 14:50
        
        Deficiency letters kumarnaidu 2013-12-05 06:18
        
        Simulations Helmut 2013-12-05 15:51
        
        Simulations kumarnaidu 2013-12-05 16:07
        
        Simulations Helmut 2013-12-05 16:55
        
        Simulations kumarnaidu 2013-12-06 06:07
        
        Ejaculatio praecox Helmut 2013-12-06 14:30
        
        Ejaculatio praecox kumarnaidu 2013-12-06 15:13
        
        All effects fixed Helmut 2013-12-06 15:31
        
        All effects fixed kumarnaidu 2013-12-09 07:33
        
        EMA… Helmut 2013-12-09 12:45

Difference between two stage and group sequential design niraj.bhatt 2013-12-04 04:25
- Difference between two stage and group sequential design kumarnaidu 2013-12-04 05:45
- Terminology Helmut 2013-12-04 15:35
  - Terminology niraj.bhatt 2013-12-06 06:47

Potvin’s TSDs in the EU Helmut 2013-10-30 18:48
- Partial thumbs up to AGES ElMaestro 2013-10-30 19:26
  - AGES & numeric precision Helmut 2013-10-31 15:01
    - AGES & numeric precision ElMaestro 2013-10-31 18:16
- Potvin’s TSDs in the EU Shuanghe 2013-10-31 10:48
  - Exegesis Helmut 2013-10-31 12:51
  - Potvin’s TSDs in the EU ElMaestro 2013-10-31 13:04

Potvin’s 2-stage adaptive design GSD 2012-08-17 20:56
- Potvin’s 2-stage adaptive design + RSABE/ABEL Helmut 2012-08-18 00:39
  - Potvin’s 2-stage adaptive design + RSABE/ABEL GSD 2012-08-31 16:30
    - Tough job Helmut 2012-08-31 18:37
      - Tough job GSD 2012-08-31 19:23
        
        C/D for EMA? Good luck! Helmut 2012-09-01 15:09
      - Surprise? d_labes 2012-09-05 12:57
        
        Got it. Ages for sims to complete Helmut 2012-09-05 13:35
        
        Life belt d_labes 2012-09-05 14:51
        
        Life belt Helmut 2012-09-05 15:20
  - Power for Two stage Design K2K 2013-10-07 14:43
    - Power for Two stage Design Helmut 2013-10-07 14:59
      - Power for Two stage Design K2K 2013-10-08 14:35
        
        “Interim power” Helmut 2013-10-08 14:58
        
        “Interim power” K2K 2013-10-09 12:39
        
        Validation of PowerTOST Helmut 2013-10-09 14:10
        Phoenix/WinNonlin - power d_labes 2013-10-09 16:11
        
        Phoenix/WinNonlin - power Helmut 2013-10-09 18:19
        
        power K2K 2013-10-10 08:36

Method C’s α ⇒ B Helmut 2013-08-17 15:49

Parallel Power Problems ElMaestro 2013-02-14 14:46
- Parallel Power shifted d_labes 2013-02-15 09:16
  - Doubts explained ElMaestro 2013-02-15 11:37
    - Formulas d_labes 2013-02-15 14:31
      - Formulas ElMaestro 2013-02-15 16:16

Add-on study data combining procedure msmnainar 2013-02-14 08:08
- Add-on study data combining procedure drgunasakaran1 2013-02-14 09:54
  - Add-on study data combining procedure msmnainar 2013-02-14 10:39
    - Ref’s for Methods C/D Helmut 2013-02-14 13:32
      - Ref’s for Methods C/D msmnainar 2013-02-14 13:40
  - No more add-ons for submissions in Canada Helmut 2013-02-14 13:22

Brave New World (no pun!) Helmut 2013-01-21 23:06
- Brave New World (no pun!) ElMaestro 2013-01-22 10:51

Another Two-Stage ‘idea’ (lengthy) Helmut 2012-12-01 01:50
- Not a PSRtPH that can be defended ElMaestro 2012-12-01 22:20
  - Full adaptive without α-spending? Helmut 2012-12-02 11:43
    - Full adaptive with futility rule d_labes 2012-12-05 08:38
      - Full adaptive with futility rule Helmut 2012-12-05 19:56
  - Piece of paper… Helmut 2012-12-03 02:07
    - Piece of paper… ElMaestro 2012-12-03 07:19
      - Piece of paper… Helmut 2012-12-03 13:02

Potvin – all effects fixed (PHX/WNL vs. SAS, R) Helmut 2012-10-26 19:35
- Potvin – all effects fixed (PHX/WNL vs. SAS, R) ElMaestro 2012-10-26 20:14
  - Potvin – all effects fixed (PHX/WNL vs. SAS, R) Helmut 2012-10-26 20:25
    - Potvin – all effects fixed (PHX/WNL vs. SAS, R) ElMaestro 2012-10-26 22:05
- Potvin – all effects fixed - SAS d_labes 2012-10-29 09:57
  - Potvin – all effects fixed (PHX/WNL resolved) Helmut 2012-11-06 01:43
    - Potvin – all effects fixed (PHX/WNL resolved) ElMaestro 2012-11-06 11:48
      - Potvin – all effects fixed (PHX/WNL resolved) Helmut 2012-11-06 13:48
        
        Mysterious ways ElMaestro 2012-11-06 15:27
        
        Mysterious ways Helmut 2012-11-06 17:06

Sequence imbalance and 2-stage designs ElMaestro 2012-10-30 19:44

2-stage maximum likelihood of CV/RMSE, given T/R ElMaestro 2012-10-22 15:06
- Not sure whether I understand this Helmut 2012-10-22 15:40
  - Not sure whether I understand this ElMaestro 2012-10-22 16:34
    - Not sure whether I understand this d_labes 2012-10-23 16:44
      - Not sure whether I understand this ElMaestro 2012-10-23 16:55
        
        Not sure whether I understand this Helmut 2012-10-23 17:17
        
        Ach du lieber ElMaestro 2012-10-23 20:51