Bioequivalence and Bioavailability Forum

WHO Draft on BCS-based Biowaivers Helmut 2023-08-29 11:18

ICH E6(R3) draft Guideline reaches Step 2 of the ICH process SMA 2023-05-24 08:37
- Validation of sample size estimations? Helmut 2023-05-29 08:34

FDA draft guidance on transdermal systems Ohlbe 2023-04-13 08:37

ICH M13A (IR BE) Helmut 2022-12-23 09:05
- ICH M13A (IR BE) Rasha_J 2023-01-16 05:27
  - ICH M13A (IR BE) Helmut 2023-01-16 09:19
  - ICH M13A (IR BE) SMA 2023-01-17 09:30
  - ICH M13A (IR BE) dshah 2023-01-17 12:02
  - ICH M13A (IR BE) Rasha_J 2023-01-18 09:53
  - ICH M13A (IR BE) : FDA web site Ohlbe 2023-02-01 14:14
    - Knowledge is power… Helmut 2023-02-09 12:34
- ICH M13A (IR BE): EMA consultation SMA 2023-02-08 09:10
  - ICH M13A (IR BE): EMA comments received Helmut 2023-09-18 10:54

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- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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

EMA: New product-specific guidances Helmut 2022-04-08 15:17
- How would you implement it? ElMaestro 2022-04-09 11:45
  - Confuse a Cat Inc. Helmut 2022-04-09 18:40
    - Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
      - Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
        
        Confuse a Cat Inc. Helmut 2022-04-11 13:59
        
        Range Ohlbe 2022-04-11 15:48
        
        Range Helmut 2022-04-11 16:07
        
        Range Ohlbe 2022-04-11 16:20
        
        Range Helmut 2022-07-28 14:43
      - So many questions, so few answers Helmut 2022-04-11 13:03
      - Preliminary simulations Helmut 2022-04-30 14:59
        
        Preliminary simulations ElMaestro 2022-04-30 19:10
        
        Preliminary simulations Helmut 2022-05-01 15:56
        Revisions of the PSGLs final Helmut 2023-06-23 13:29
        
        Revisions of the PSGLs final dshah 2023-06-28 14:43
        
        EMA: No problems with many sampling time points… Helmut 2023-06-28 15:59
        New simulations & some desultory thoughts Helmut 2023-06-29 11:34
        
        SCNR. A heretic alternative. Helmut 2023-06-30 11:50
      - Simulated distributions Helmut 2022-05-02 13:43

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

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

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