Bioequivalence and Bioavailability Forum

New guidance on Statistical Approaches to Establishing Bioequivalence Relaxation 2022-12-02 15:53
- A first look Helmut 2022-12-02 16:43
  - A first look jag009 2022-12-02 17:58
    - A first look BRB 2022-12-02 18:20
  - SAS strikes back mittyri 2022-12-02 20:38
    - SAS strikes back Helmut 2022-12-02 22:30
      - Outliers? mittyri 2022-12-02 22:52
        
        Outliers? Helmut 2022-12-02 23:11
      - SAS strikes back Achievwin 2023-02-07 07:23
  - model-based BE? mittyri 2022-12-07 16:26
    - model-based BE? Helmut 2022-12-10 10:13
      - Hooker, Moellenhoff et al. are moving MBBE forward mittyri 2023-01-11 15:32
      - model-based BE? SMA 2023-01-17 09:41
  - A first look PharmCat 2022-12-21 19:30
  - A first look Rayhope 2023-01-06 06:56
- Groups, sites… Helmut 2022-12-03 13:09
- SxF ElMaestro 2022-12-04 06:34
  - SxF Helmut 2022-12-10 10:37
- New guidance on Statistical Approaches to Establishing Bioequivalence Mahmoud 2022-12-10 14:08
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13
    - Multi-group studies ad nauseam Helmut 2023-02-07 11:30
      - Multi-group studies ad nauseam Achievwin 2023-02-25 16:18
    - Webinar: Recording available Helmut 2023-04-01 10:38
  - Speed kills Helmut 2023-02-07 13:02

EMA Methodology Working Party Helmut 2022-10-01 09:53
- EMA Methodology Working Party dshah 2022-11-08 10:09

ANVISA RDC Nº 742 Helmut 2022-09-12 10:27
- ANVISA RDC Nº 749 dshah 2022-09-16 19:13

ICH M12 (DDI studies) Helmut 2022-07-29 13:53

Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology suchit_bhavsar 2022-06-29 07:37

Publication of the final ICH M10 guideline Ohlbe 2022-06-10 10:48
- Publication of the final ICH M10 guideline qualityassurance 2022-06-12 12:31
  - Chromatograms Ohlbe 2022-06-14 11:37

New FDA bioavailability guidance wienui 2022-04-15 09:44
- New FDA bioavailability guidance Relaxation 2022-04-16 13:59
  - New FDA bioavailability guidance zizou 2022-04-16 18:22
    - Excellent post! Helmut 2022-04-17 13:03

Bempedoic Acid TBM BE study in SBOA dshah 2022-03-30 17:09
- Bempedoic Acid TBM BE study in SBOA jag009 2022-03-31 08:43

Observational studies Helmut 2021-12-27 10:24
- Observational studies d_labes 2021-12-28 10:27
  - … real-world evidence … Helmut 2022-02-11 10:38

EMA BE-GL: Clarifications / Corrections? Helmut 2010-06-22 18:53
- Good news!? d_labes 2010-06-23 10:09
  - Good news!? Helmut 2010-06-23 10:11
    - Update Helmut 2011-02-05 18:48
      - Q&A published 14 March 2011 Helmut 2011-03-16 13:44
        
        Q&A published 14 March 2011 ElMaestro 2011-03-16 14:20
        Phoenix/WinNonlin 6.1.0.173 Helmut 2011-03-17 04:23
        ANOVA party prevails d_labes 2011-03-17 11:00
        
        THX! Helmut 2011-03-19 02:59
        
        Outlier d_labes 2011-03-24 11:55
        
        Outliers - yes, but how? Helmut 2011-03-24 15:09
        
        Questions and Ambiguities d_labes 2011-03-28 14:16
        Residuals and Outliers in Replicate Design Crossover Studies d_labes 2011-04-04 08:53
        
        Info requested ElMag 2011-03-24 12:45
        
        Confused as well... Helmut 2011-03-24 16:50
        
        Q&A published 14 March 2011 Priyanka_S 2011-03-21 14:28
        
        SAS code: Warning d_labes 2011-03-21 16:08
        
        Copy & paste Helmut 2011-03-21 22:38
        
        Subtleties, flaws, questions d_labes 2011-03-22 09:24
        
        Subtleties, flaws, questions Helmut 2011-03-27 20:35
        
        Not estimable in the model The user 2017-03-14 10:16
        
        Not estimable in the model ElMaestro 2017-03-14 11:02
        
        Not estimable in the model The user 2017-03-14 12:13
        
        Not estimable in the model ElMaestro 2017-03-14 12:41
        
        Not estimable in the model Helmut 2017-03-18 21:59
        
        Food not the same between groups Beholder 2021-11-10 14:35
        
        Food not the same between groups ElMaestro 2021-11-17 09:50

English translation of Japanese guidelines Ohlbe 2021-10-26 11:48

GCC guidelines v3.0 Helmut 2021-10-25 20:03

4th GBHI report Helmut 2021-09-29 18:03

FDA guideline on BE, draft August 2021 ElMaestro 2021-08-23 14:42
- FDA guideline on BE, draft August 2021 Helmut 2021-08-23 15:31
  - FDA guideline on BE, draft August 2021 Achievwin 2021-09-08 04:09
    - Bias correction unveiled Helmut 2021-09-10 20:47
- FDA guideline on BE, draft August 2021 Achievwin 2021-08-23 21:35
  - FDA guideline on BE, draft August 2021 Helmut 2021-08-23 23:46

WHO: scaling for AUC? Ohlbe 2017-06-12 13:29
- WHO: Chapeau! Helmut 2017-06-12 23:31
  - WHO: Chapeau! ElMaestro 2017-06-13 00:08
    - WHO: Chapeau! nobody 2017-06-13 09:28
    - WHO: Chapeau! Helmut 2019-06-10 11:23
      - WHO: Chapeau! ElMaestro 2019-06-11 18:51
- WHO: scaling for AUC confirmed Ohlbe 2021-07-02 10:31
  - No comparison of variabilities any more? Helmut 2021-07-02 15:11
  - WHO: scaling for AUC confirmed kratos 2021-08-03 10:38
    - EMA: scaling for AUC = utopia Helmut 2021-08-03 12:54