Bioequivalence and Bioavailability Forum

Outlier in fully replicate BE study Loky do 2021-06-16 00:49
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
  - Widening for clopidogrel BE study Loky do 2021-06-16 15:38
    - Widening for clopidogrel BE study mittyri 2021-06-16 16:04
      - Widening for clopidogrel BE study Loky do 2021-06-16 17:08
        
        Widening for clopidogrel BE study - cherry-picking? mittyri 2021-06-16 17:27
        Widening for clopidogrel BE study drgunasakaran1 2021-06-17 12:01
        Hypotheses Helmut 2021-06-19 12:32
        
        Hypotheses Loky do 2021-07-06 11:51
        
        ABEL ≠ RSABE Helmut 2021-07-06 16:17

Exclusion of Outlier Data surajpatel 2021-05-27 08:14
- Exclusion of Outlier Data drgunasakaran1 2021-05-27 08:58
- Health Canada: read the guidance Helmut 2021-05-27 10:14

diarrhea in Extended release study Researcher101 2020-09-23 21:53
- diarrhea in Extended release study dshah 2020-09-24 12:05
- diarrhea in Extended release study ElMaestro 2020-09-24 13:18

Outlier Test using R-Software and Phoenix WinNonlin software in the BE udayk 2020-03-06 09:00
- Outlier Test using R-Software and Phoenix WinNonlin software in the BE ping4santosh 2020-03-11 14:58
- Studentized & standardized residuals Helmut 2020-03-13 11:21
- Outlier Test using R-Software: Lund test ping4santosh 2020-03-14 14:52
  - Outlier Test using R-Software: Lund test udayk 2020-03-20 07:05
    - Outlier Test using R-Software: Lund test ping4santosh 2020-03-20 10:07
- bear for outlier detection analysis? yjlee168 2020-03-20 14:45

Outlier Tests GM 2018-07-30 13:57
- Outlier Tests GM 2019-02-14 07:24
- Outlier Tests ElMaestro 2019-02-14 09:27
  - Outlier Tests GM 2019-02-14 19:08
    - Outlier Tests ElMaestro 2019-02-14 22:11
      - Outlier Tests GM 2019-02-15 04:58

AUC <5% of TEST geometric mean AUC vezz 2019-02-13 08:35
- AUC <5% of TEST geometric mean AUC ElMaestro 2019-02-13 09:36
  - AUC <5% of TEST geometric mean AUC vezz 2019-02-13 10:08
    - AUC <5% of TEST geometric mean AUC ElMaestro 2019-02-13 12:09

Rules acc. to Health Canada Helmut 2019-02-05 15:04
- Rules acc. to Health Canada ElMaestro 2019-02-05 15:30
  - Rules acc. to Health Canada Helmut 2019-02-05 16:24
    - Rules acc. to Health Canada ElMaestro 2019-02-05 17:33
- Rules acc. to Health Canada Ohlbe 2019-02-05 15:54
  - Rules acc. to Health Canada Helmut 2019-02-05 17:52
- for either the test or reference product? mittyri 2019-02-05 15:58
  - Discordant outliers Helmut 2019-02-05 17:42
- Rules acc. to Health Canada Shuanghe 2019-02-06 11:48
  - Rules acc. to Health Canada ElMaestro 2019-02-06 12:20
    - ESD? mittyri 2019-02-06 14:04
      - ESD? ElMaestro 2019-02-06 18:12
- Rules acc. to Health Canada zizou 2019-02-06 20:52
  - Great post! Helmut 2019-02-07 10:37

Subject exclusion Mohamed Yehia 2018-10-02 21:25
- Subject exclusion Ohlbe 2018-10-02 21:30
  - Subject exclusion Mohamed Yehia 2018-10-02 21:38
    - Subject exclusion Ohlbe 2018-10-02 21:46
      - Subject exclusion Mohamed Yehia 2018-10-02 22:18
        
        Subject exclusion Ohlbe 2018-10-02 22:35
        
        Subject exclusion Mohamed Yehia 2018-10-02 22:45
        
        Subject exclusion Ohlbe 2018-10-02 22:51
        
        Subject exclusion Mohamed Yehia 2018-10-02 22:55
        
        Subject exclusion Helmut 2018-10-02 23:27
        
        Subject exclusion Mohamed Yehia 2018-10-02 23:51
        
        Subject exclusion Helmut 2018-10-03 23:47

Outliers in Replicated Crossover Study pash413 2016-07-11 09:04
- Which agency? Helmut 2016-07-11 12:56
  - Which agency? pash413 2016-07-11 17:01
    - Residuals and Critical value Calculation? pash413 2016-07-14 08:00
- Outliers in Replicated Crossover Study DavidManteigas 2016-07-12 16:55
  - Outliers in Replicated Crossover Study Ohlbe 2016-07-12 17:50
- Outliers in Replicated Crossover Study ElMaestro 2016-07-13 18:49
  - I would stop Helmut 2016-07-13 19:56
- Outliers in Replicated Crossover Study pjs 2017-10-05 15:46
  - Sample size for the FDA NTID BE decision d_labes 2017-10-05 17:25

Multiple Outliers using Lund’s Procedure Pankaj Bhangale 2014-07-10 14:23
- Repetitive testing? Helmut 2014-07-10 15:42
  - Repetitive testing? Pankaj Bhangale 2014-07-11 13:30

FDA: Mini-study (retesting) Helmut 2014-05-26 17:50
- FDA: Mini-study (retesting) jag009 2014-05-27 21:52

Outlier in a BE study auditor 2013-11-14 10:38
- Outlier in a BE study Dr_Dan 2013-11-14 14:41
  - Outlier in a BE study Erkin 2014-01-21 19:21
    - Outliers: reasons to not analyse? mittyri 2014-01-30 20:14
      - I wouldn’t do that Helmut 2014-02-06 02:35
- Outlier in a BE study jag009 2013-11-15 22:06
- Outlier in a BE study riteshsrmc 2014-01-16 12:44
  - Outlier in a BE study Helmut 2014-01-16 14:54
- Outlier in a BE study luvblooms 2014-01-27 09:11

Replicate Study designs balakotu 2014-01-08 08:14
- Replicate Study designs Dr_Dan 2014-01-08 09:54
  - Replicate Study designs Mahesh M 2014-01-08 13:18
    - Replicate Study designs Dr_Dan 2014-01-08 15:24
      - Replicate Study designs jag009 2014-01-08 15:33
      - Re-testing Helmut 2014-01-08 16:16
- Replicate Study designs Ohlbe 2014-01-08 14:24

Replicate balakotu 2014-01-08 10:27

"Removal" of an outlier: subject vs period lechia 2013-08-06 23:23
- "Removal" of an outlier: subject vs period ElMaestro 2013-08-07 11:09
- Canada: subject, not period Helmut 2013-08-07 13:48
  - Proc GLM with missings d_labes 2013-08-07 14:46
    - Proc GLM with missings jag009 2013-08-07 15:03
    - Proc GLM with missings Helmut 2013-08-07 15:21
      - Proc GLM with missings ElMaestro 2013-08-07 15:39
        
        Proc GLM with missings ElMaestro 2013-08-07 16:22
        Proc GLM random d_labes 2013-08-07 16:46
      - Proc GLM with missings for 2x2 crossover d_labes 2013-08-07 16:34
  - Canada: subject, not period lechia 2013-08-07 15:46
    - Canada: subject, not period Helmut 2013-08-07 15:57
  - Canada: subject, not period lechia 2013-08-12 15:48

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