Bioequivalence and Bioavailability Forum

two-stage Yura 2016-11-21 11:18
- two-stage Helmut 2016-11-21 11:41
  - two-stage Yura 2016-11-21 12:44

Reference scaled BE - FDA (and FARTSSIE update) ddubins 2010-04-26 20:28
- Reference scaled ABE - FDA d_labes 2010-04-27 08:58
  - Reference scaled ABE - FDA ElMaestro 2010-04-27 13:39
    - Factor 2 is unbiased d_labes 2010-04-27 14:30
    - Biased bonus from MoM d_labes 2010-05-04 12:10
      - Biased bonus from MoM ElMaestro 2010-05-04 12:54
        
        Mixed MoM d_labes 2010-05-04 14:40
        
        Mixed MoM ElMaestro 2010-05-04 15:08
        
        R and G, CSH and UN d_labes 2010-05-05 10:42
        
        A sailor gets confused ElMaestro 2010-05-05 11:49
        
        Confused V/Z matratzen and tips d_labes 2010-05-05 14:49
        
        superb post! ElMaestro 2010-05-05 21:32
        
        Gambling with UN d_labes 2010-05-06 11:00
        
        Mixed MoM yjlee168 2010-05-05 09:12
- Reference scaled BE - FDA (and FARTSSIE update) KR 2010-04-27 13:14
- Reference scaled BE - EMA Helmut 2010-04-27 14:58
  - Reference scaled BE - EMA ddubins 2010-04-27 17:52
    - Partial replicate design and FDA ABE code d_labes 2010-04-28 09:47
    - Reference scaled BE - EMA Helmut 2010-04-28 14:46
    - Switching - null sWR d_labes 2010-05-04 14:04
- The unknown x d_labes 2010-05-06 13:26
  - The unknown x jdetlor 2010-09-28 17:22
    - Unknown x corrected? d_labes 2010-10-01 12:14
      - Unknown x corrected? Qilex 2016-09-21 12:25
        
        Official unknown x d_labes 2016-09-21 13:22

CVwr and Swr Jay 2016-06-22 10:37
- CVwr for switching to widening d_labes 2016-06-22 15:24
- CVwr and Swr DavidManteigas 2016-06-23 10:52

Analysis Sets and Handling of Dropouts and Missing Values munsoned 2016-05-04 03:53
- Dropouts and Missing Values in RSABE d_labes 2016-05-04 09:27

Statistical Model for HVD Canada Regulatory pash413 2016-04-04 16:01
- Statistical model for replicate designs Canada d_labes 2016-04-05 13:04
  - Statistical model for replicate designs Canada pash413 2016-04-05 13:14
- Reference? Helmut 2016-04-09 14:24

EMA: adjusted α Helmut 2015-11-18 00:27
- EMA: adjusted α for scABEL (for no-nerds) d_labes 2015-11-18 08:25
  - In praise of PowerTOST Helmut 2015-11-18 16:01
- iteratively adjusted α Helmut 2015-11-28 22:35
  - iteratively adjusted α - FDA d_labes 2015-12-08 09:35

Mesalazine tablets for Europe Market balakotu 2015-10-19 09:47
- Mesalazine tablets for Europe Market komodo 2015-10-23 08:52
  - Generic of an extremely HVDP possible? Helmut 2015-10-23 13:09
    - Generic of an extremely HVDP possible? nobody 2015-10-23 14:46

RSABE: Statistics & Regulatory requirements Dhruv Shah 2015-09-28 11:08
- RSABE: Statistics & Regulatory requirements jag009 2015-10-01 13:57
- RSABE: Statistics & Regulatory requirements d_labes 2015-10-01 16:23

ISCV and CI AB 2012-02-08 08:21
- ISCV and CI drgunasakaran1 2012-02-08 08:44
- Sample size feasible d_labes 2012-02-08 09:47
  - Sample size feasible AB 2012-02-08 11:40
    - No worries! Helmut 2012-02-08 13:37
    - Sample size down! d_labes 2012-02-08 14:18
      - World record? Helmut 2012-02-08 14:31
        
        Wow! d_labes 2012-02-08 16:16
        
        Wow! Helmut 2012-02-08 16:24
        
        Wow! AB 2012-02-08 16:48
        
        World record? jag009 2015-09-23 20:43
        
        Nope Helmut 2015-09-23 21:57

Drug Variability ISCV Anand 2015-07-28 13:47
- Science is a cruel mistress Helmut 2015-07-28 14:31

3 period full replicate Dr_Dan 2015-06-24 13:55
- 3 period full replicate ElMaestro 2015-06-24 14:11
- 3 period full replicate Helmut 2015-06-24 14:29
- 3 period full replicate d_labes 2015-06-24 14:38
  - 3 period full replicate Dr_Dan 2015-06-24 16:43
    - 3 period full replicate Helmut 2015-06-24 18:00
      - 3 period full replicate ElMaestro 2015-06-24 18:11
        
        3 period full replicate Helmut 2015-06-24 18:25
        
        3 period full replicate d_labes 2015-06-25 08:52
        
        3 period full replicate ElMaestro 2015-06-25 10:37
        
        OT d_labes 2015-06-25 11:20
        
        OT ElMaestro 2015-06-25 11:54
        
        OT d_labes 2015-06-25 13:51
    - CVs (borderline OT) Helmut 2015-06-26 13:51
      - CVs (R, T) from pooled CV d_labes 2015-07-02 09:09
        
        Answering an unasked question Helmut 2015-07-02 13:03
        
        Answer to an unasked answer d_labes 2015-07-02 14:21
        
        Bloody typo! Helmut 2015-07-02 14:33
      - CVs (borderline OT) zizou 2015-07-05 19:20
        
        Degrees of freedom 3-period full replicate d_labes 2015-07-06 11:10
        
        Degrees of freedom 3-period full replicate ElMaestro 2015-07-06 11:59
        
        Degrees of freedom 3-period full replicate d_labes 2015-07-06 13:53
        
        Degrees of freedom 3-period full replicate zizou 2015-07-06 17:25
- The almighty oracle has spoken! Helmut 2015-07-23 23:54
  - Almighty oracle's mysterious saying d_labes 2015-07-24 08:23

Restriction on widened limit -AUC of HVD ashokraj 2015-07-22 14:26
- No scaled ABE for AUC d_labes 2015-07-22 16:03
- History lesson Helmut 2015-07-22 16:26

Sample size calculation for R-SABE Lucas 2014-02-07 11:41
- EMA’s ABEL Helmut 2014-02-07 14:21
  - EMA’s ABEL Lucas 2014-02-07 16:49
    - Carry-over Helmut 2014-02-07 17:12
      - Carry-over Lucas 2014-02-07 17:42
        
        Carry-over Shuanghe 2014-02-10 17:11
- PowerTOST and Sample size estimation for R-SABE d_labes 2014-02-07 14:37
  - PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-18 13:38
    - PowerTOST and Sample size estimation for R-SABE Dr_Dan 2014-04-18 19:29
      - PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-19 06:04
  - PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 01:14
    - Sample size for scABEL/RSABE vs. conventional ABE d_labes 2015-06-25 09:19
    - PowerTOST and Sample size estimation for R-SABE mittyri 2015-06-25 10:43
      - PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 13:54
        
        Scaled ABE d_labes 2015-06-25 14:04

SAS code for 3-period, partial-replicated crossover study scorp2011 2015-06-15 12:36
- SAS code for 3-period, partial-replicated crossover study d_labes 2015-06-15 13:24
  - SAS code for 3-period, partial-replicated crossover study MGR 2015-06-15 13:34
    - SAS code for 3-period, partial-replicated crossover study ElMaestro 2015-06-15 13:46
      - Partial-replicated crossover study with 2 Tests d_labes 2015-06-15 14:50

ANVISA’s home brewed scaling? Helmut 2015-05-28 18:27
- ANVISA’s home brewed scaling? ElMaestro 2015-05-28 19:10
  - ANVISA: TIE, sample size Helmut 2015-06-02 16:00
    - ANVISA: scABEL TIE d_labes 2015-06-03 11:59
      - ANVISA: scABEL TIE Helmut 2015-06-03 12:07
        
        ANVISA: scABEL TIE part II d_labes 2015-06-03 13:19
        
        ANVISA: scABEL TIE part II nobody 2015-06-03 13:31
        
        ANVISA: scABEL TIE part II d_labes 2015-06-03 14:00
        
        ANVISA scABEL - sample size d_labes 2015-06-05 11:03
- ANVISA’s home brewed scaling? Lucas 2015-06-02 16:02
  - ANVISA’s home brewed scaling? Helmut 2015-06-02 16:16