Bioequivalence and Bioavailability Forum

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

Different power of AUC vs. Cmax at stage I - continuation rules Nisha 2015-09-17 13:28
- Different power of AUC vs. Cmax at stage I - continuation rules ElMaestro 2015-09-17 13:56
  - Different power of AUC vs. Cmax at stage I - continuation rules Nisha 2015-09-17 20:27
    - AUC vs. Cmax ElMaestro 2015-09-17 21:53
    - Assumption Helmut 2015-09-18 00:15

Does unequal alpha distribution make sense? Dr_Dan 2015-05-19 08:29
- Maybe; but watch the TIE! Helmut 2015-05-28 15:04
  - Advantages d_labes 2015-06-05 09:35
    - Advantages ElMaestro 2015-06-05 10:07
      - Advantages – performance measure d_labes 2015-06-05 11:21
        
        Advantages – performance measure Helmut 2015-06-05 13:29
        
        Advantages – performance measure d_labes 2015-06-05 21:27
        
        Advantages – performance measure Helmut 2015-06-05 23:29
        
        Histogram wonder d_labes 2015-06-06 12:58
        
        Histogram charlatanry Helmut 2015-06-09 13:43
        
        Histogram beauty d_labes 2015-06-09 14:55
        
        Histogram beast Helmut 2015-06-09 15:24
- Does unequal alpha distribution make sense? Dr_Dan 2015-05-29 08:33
  - Does unequal alpha distribution make sense? ElMaestro 2015-05-29 09:31
    - Does unequal alpha distribution make sense? nobody 2015-05-29 12:56
      - Old beliefs die hard Helmut 2015-05-29 13:27
        
        Old beliefs die hard nobody 2015-05-29 13:41
        
        Old beliefs die hard Helmut 2015-05-29 18:08
        
        Old beliefs die hard ElMaestro 2015-05-29 18:57
        
        Old beliefs die hard nobody 2015-05-29 20:06
        ♩ ♪♫♬`·.¸¸.·´`·.¸¸. Helmut 2015-06-02 01:52
        
        TSD only an option in exceptional cases Dr_Dan 2015-06-02 08:00
        
        TSD only an option in exceptional cases nobody 2015-06-02 09:23
        
        OT Helmut 2015-06-02 12:07
        
        OT nobody 2015-06-02 12:41
- Banana splits Helmut 2015-06-02 00:48

TSD subjects participation in both stages Dr_Dan 2015-05-12 16:35
- Interesting idea! Helmut 2015-05-12 17:05
  - Interesting idea! Dr_Dan 2015-05-12 18:11
- TSD subjects participation in both stages ElMaestro 2015-05-12 17:22
- TSD subjects participation in both stages - ANOVA d_labes 2015-05-13 09:33

TSDs for RSABE/ABEL Helmut 2015-05-06 02:17
- TSDs for RSABE/ABEL nobody 2015-05-06 11:13
  - TSDs for RSABE/ABEL Helmut 2015-05-06 11:55
    - TSDs for RSABE/ABEL nobody 2015-05-06 12:26
- TSDs for RSABE/ABEL ElMaestro 2015-05-06 12:31
  - TSDs for RSABE/ABEL Helmut 2015-05-06 13:49
- TSDs for RSABE/ABEL - run-time d_labes 2015-05-08 20:47
  - Really worth the efforts? Helmut 2015-05-10 01:11

Advanced example (futility for GMR) Helmut 2015-02-27 02:03
- Advanced example (futility for GMR) d_labes 2015-02-27 09:55
  - Advanced example (futility for GMR) Helmut 2015-02-27 10:43
    - Numbers d_labes 2015-02-27 11:03
      - Typos Helmut 2015-02-27 11:22

Gimmick & survey Helmut 2015-02-20 01:47
- Gimmick & survey nobody 2015-02-20 08:25
  - Gimmick & survey Helmut 2015-02-20 13:01
    - Gimmick & survey nobody 2015-02-20 14:18
      - Speeed! Helmut 2015-02-20 15:38
        
        Speeed! nobody 2015-02-20 16:37
        
        Speeed! Helmut 2015-02-20 16:58
        
        Speeed! nobody 2015-02-20 17:01
        
        Speeed! ElMaestro 2015-02-20 23:48
        
        Speeed! Helmut 2015-02-21 01:11
        
        Unrolled example ElMaestro 2015-02-21 01:32
        
        Unrolled example Helmut 2015-02-21 01:50
        
        Unrolled example ElMaestro 2015-02-21 02:27
        
        Increasing vector & another example Helmut 2015-02-21 13:13
        
        Speeed! nobody 2015-02-21 21:02

Type 1: n2=2 (EMA), no interim power (NL?) Helmut 2015-02-13 13:29
- Type 1: no interim power (NL?) d_labes 2015-02-13 14:53
  - Type 1: no interim power (NL?) Helmut 2015-02-13 15:22

Full Replicate Study Design prashantmohite 2015-01-28 06:56
- Full Replicate Study Design – search the Forum Dr_Dan 2015-01-28 08:38

Two-Stage Design with Fully replicate for CANADA? Rakesh_20 2015-01-22 10:26
- Two-Stage Design with Fully replicate for Canada ElMaestro 2015-01-22 10:56
- RSABE/TSD-combo Helmut 2015-01-22 12:37
  - Fully replicated-conventional ABE/TSD-combo Rakesh_20 2015-01-23 06:32
    - Simulations mandatory Helmut 2015-01-23 12:41