Bioequivalence and Bioavailability Forum

EMA: Draft GL for OIPs Helmut 2024-04-19 15:40
- EMA: Draft GL for OIPs Chirag 2024-04-22 04:37
  - EMA: Draft GL for OIPs Ohlbe 2024-04-22 14:07

Draft FDA guidance on data integrity in BA and BE studies Ohlbe 2024-04-02 14:49

Handling and Retention of BA and BE Testing Samples suchit_bhavsar 2024-03-27 04:09

Handling and Retention of BA and BE Testing Samples dshah 2024-03-26 17:15

Paper by the IPRP BEWGG Ohlbe 2024-03-22 16:25

New EMA product specific guidance (PSG) SMA 2024-01-16 09:51
- New EMA product specific guidance (PSG) dshah 2024-01-17 10:12

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FDA draft guidance on transdermal systems Ohlbe 2023-04-13 08:37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- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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

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