Bioequivalence and Bioavailability Forum

BE assessment regarding first time point Cmax Mann 2018-12-09 10:14
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
  - BE assessment regarding first time point Cmax Mann 2018-12-10 00:28
    - BE assessment regarding first time point Cmax Ohlbe 2018-12-11 00:05
    - FDA and outliers mittyri 2018-12-11 16:38
    - BE assessment regarding first time point Cmax Erkin 2018-12-28 08:29
      - BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
        
        BE assessment regarding first time point Cmax Erkin 2018-12-28 20:57
        
        regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
        
        Good question, next question Helmut 2019-03-03 19:42
        
        first point Cmax: trouble waiting to happen? Astea 2019-03-03 21:42

Thalidomide Rosy 2019-02-19 23:09
- Thalidomide jag009 2019-02-26 16:07

CV values in BE studies: intra, or inter, or total? Elena777 2018-01-20 12:31
- CV values in BE studies: intra, or inter, or total? jag009 2018-01-20 19:18
  - CV values in BE studies: intra, or inter, or total? Elena777 2018-01-20 21:10
    - CV values in BE studies: intra, or inter, or total? jag009 2018-01-21 03:17
      - CV values in BE studies: intra, or inter, or total? Elena777 2018-01-21 08:21
- CV values in BE studies: intra, or inter, or total? Helmut 2018-01-21 17:33
- CV values in BE studies: intra, or inter, or total? ElMaestro 2018-01-21 18:17
  - CV values in BE studies: intra, or inter, or total? Elena777 2018-01-27 09:57
    - CV values in BE studies: intra, or inter, or total? Louis52 2018-02-07 20:22
      - CV values in BE studies: intra, or inter, or total? Helmut 2018-02-07 20:31
        
        CV values in BE studies: intra, or inter, or total? Rosy 2019-02-19 18:33
        
        PowerTOST: CVfromCI Helmut 2019-02-20 13:00
        
        PowerTOST: CVfromCI -> CI.BE d_labes 2019-02-20 14:12
        
        Oops! Helmut 2019-02-20 15:32
        
        Oops! df? d_labes 2019-02-20 19:45
        
        Oops! df? Helmut 2019-02-20 20:43
        
        Oops! df! d_labes 2019-02-21 10:54
        Oops! df? zizou 2019-02-21 11:33
        
        Oops! df? nobody 2019-02-21 12:42
        All the answers are here d_labes 2019-02-21 14:49
        
        PowerTOST: CVfromCI Rosy 2019-02-20 15:25
        
        type known.designs() in PowerTOST Helmut 2019-02-20 16:14
        
        type known.designs() in PowerTOST Rosy 2019-02-20 17:14

Dose Proportionality and Variance AngusMcLean 2016-05-11 16:55
- More information, please Helmut 2016-05-12 14:34
  - More information, please AngusMcLean 2016-05-13 16:40
    - Setup in Phoenix/WinNonlin Helmut 2016-05-14 02:26
      - Setup in Phoenix/WinNonlin AngusMcLean 2016-05-14 18:54
        
        Setup in Phoenix/WinNonlin Helmut 2016-05-15 14:47
        
        Setup in Phoenix/WinNonlin AngusMcLean 2016-05-15 15:17
        
        Phoenix 64 Warning Helmut 2016-05-15 15:56
        
        Phoenix 64 Warning AngusMcLean 2016-05-15 20:11
        
        OT: imperial vs. metric units Helmut 2016-05-16 16:26
        
        Setup in Phoenix/WinNonlin ElMaestro 2016-05-15 20:54
        
        Setup in Phoenix/WinNonlin AngusMcLean 2016-05-15 22:30
      - Setup in Phoenix/WinNonlin AngusMcLean 2016-05-16 21:00
        
        NCSS vs. PHX/WNL vs. SAS Helmut 2016-05-17 01:50
        
        NCSS vs. PHX/WNL vs. SAS - Validation? mittyri 2016-05-18 08:23
        
        Diagnostics ElMaestro 2016-05-18 09:20
        
        Diagnostics: R and Phoenix Helmut 2016-05-18 15:14
        
        Diagnostics: R zizou 2016-05-22 19:07
        
        Diagnostics: R Helmut 2016-05-23 01:22
        
        SASian potpourri d_labes 2016-05-24 12:02
        
        Compilation Helmut 2016-05-24 14:27
        
        REML or not d_labes 2016-05-24 16:33
        
        complete or not Helmut 2016-05-24 16:57
        
        Compilation AngusMcLean 2016-05-26 16:46
        
        doubts about NCSS Helmut 2016-05-26 19:13
        
        Doubts about NCSS zizou 2016-05-26 23:38
        
        Compilation AngusMcLean 2016-05-28 00:51
        
        Kenward-Roger? Helmut 2016-05-28 15:59
        
        90% confidence interval for R_dnm Shuanghe 2019-01-04 17:45
        
        90% confidence interval for R_dnm d_labes 2019-01-05 14:01
        
        Visualizing lmer and limits mittyri 2019-01-06 17:00
        
        Visualizing lmer and limits Shuanghe 2019-01-07 11:05
        Visualizing lmer and limits d_labes 2019-01-07 15:08
        
        Visualizing lmer and limits mittyri 2019-01-13 23:53
        
        90% confidence interval for R_dnm Shuanghe 2019-01-07 10:53
        
        90% confidence interval for R_dnm d_labes 2019-01-07 15:17
        
        90% confidence interval for R_dnm Shuanghe 2019-01-07 17:11
        
        90% confidence interval for R_dnm d_labes 2019-01-07 18:24
        offtop: greek letters and tables mittyri 2019-01-08 00:19
        
        OT: greek letters and symbols Helmut 2019-02-02 16:04
        
        Smith’s paper Helmut 2016-05-18 14:44
        
        Smith’s paper d_labes 2019-01-05 15:00

NTI Criteria Waiver sury 2018-12-24 07:04

subject withdrawn after bioanalysis anbu 2018-09-12 10:17
- Cherry-picking? Helmut 2018-09-12 12:34
  - Cherry-picking? anbu 2018-09-12 13:17

Cmax is out of the range Mikalai 2018-08-01 12:05
- Bad luck Helmut 2018-08-01 13:37
  - Bad luck Mikalai 2018-08-01 13:50
    - Cherry-picking Helmut 2018-08-01 15:01
- Cmax is out of the range jag009 2018-08-02 17:56

Definition of Enrolled subject jag009 2018-07-11 21:27
- Definition of Enrolled subject Ohlbe 2018-07-12 00:07
  - Definition of Enrolled subject jag009 2018-07-17 06:36

BE/BA centers JLpiccard 2018-07-13 20:35
- BE/BA centers Helmut 2018-07-13 22:42
  - BE/BA centers JLpiccard 2018-07-16 18:16
    - BE/BA centers Helmut 2018-07-16 18:51
- BE/BA centers ElMaestro 2018-07-13 22:42
  - BE/BA centers JLpiccard 2018-07-16 18:17

Marginally failed study for Europe balakotu 2018-04-24 07:30
- Marginally failed study for Europe Yura 2018-04-24 12:31
- Upper 90% CL 0.17% > U Helmut 2018-04-29 23:46

Outlier in BE ramgopi 2018-03-14 11:29
- Low AUC after reference product Helmut 2018-03-14 16:38
  - Low AUC after reference product mittyri 2018-03-15 10:56
- Outlier in BE ramgopi 2018-03-18 07:44
  - Outlier in BE ElMaestro 2018-03-18 14:43
    - Outlier in BE ramgopi 2018-03-19 10:55

When the the infusion speed deviate from the protocol specified ssussu 2018-02-06 10:48
- Different PK profile Helmut 2018-02-06 13:28
  - Different PK profile ssussu 2018-02-07 02:50
    - Different PK profile Helmut 2018-02-07 11:04
      - Different PK profile ssussu 2018-02-07 11:42
        
        Suitable equipment? Helmut 2018-02-07 14:13
        
        Suitable equipment? ssussu 2018-02-08 04:07
        
        AUC=f·D/CL Helmut 2018-02-08 10:28
        
        AUC=f·D/CL ssussu 2018-02-08 11:21
        
        AUC=f·D/CL Helmut 2018-02-08 21:55
        
        AUC=f·D/CL ssussu 2018-02-09 00:31
- When the the infusion speed deviate from the protocol specified ElMaestro 2018-02-07 13:20
  - When the the infusion speed deviate from the protocol specified ssussu 2018-02-08 04:23

Ever handled the "wrong treatment" in a PK? Relaxation 2018-01-26 18:31

risk management Norah 2018-01-22 13:53

ULOQ Anand 2017-10-30 06:38
- ULOQ Helmut 2017-10-30 10:30
- ULOQ Ohlbe 2017-10-30 10:35
  - ULOQ Helmut 2017-10-30 10:59
    - ULOQ Ohlbe 2017-10-30 15:10
      - Not excluding invalid data? Helmut 2017-10-30 17:34
        
        Excluding invalid data Ohlbe 2017-10-30 18:03
- ULOQ ElMaestro 2017-10-30 13:18
  - Serial dilutions? Don’t! Helmut 2017-10-30 17:53