Bioequivalence and Bioavailability Forum

Danish Agency requesting submission of CDISC data Ohlbe 2025-07-10 16:25

ICH M13B: Step 2b (draft for consultation) Helmut 2025-03-15 10:31
- ICH M13B: EMA Helmut 2025-04-09 09:10

EMA: GL on quality and equivalence of LALA cutaneous products Helmut 2024-10-03 11:41

EMA: ICH M13A coming into effect 25 January 2025 Helmut 2024-09-04 11:30

ICH M13A: Changes to Step 2 Helmut 2024-07-31 13:16
- ICH M13A: Changes to Step 2 Helmut 2024-07-31 14:19
  - AUCres mittyri 2024-08-05 21:08
    - ‘Percentage covered’ Helmut 2024-08-05 22:13
  - ICH M13A: Changes to Step 2 BEQool 2024-09-09 05:48
    - fixed or mixed effects model Helmut 2024-09-09 07:04
      - fixed or mixed effects model BEQool 2024-09-09 10:18
        
        fixed or mixed effects model Helmut 2024-09-09 11:13
        
        fixed or mixed effects model BEQool 2024-09-10 07:35
      - fixed or mixed effects model Helmut 2024-09-10 08:12
- ICH M13A: Changes to Step 2 Helmut 2024-08-05 12:53
- period within group and formulation mittyri 2024-08-05 20:42
  - period within group and formulation Helmut 2024-08-05 22:29
- ICH M13A: Step 4 → 5 Helmut 2024-08-08 11:57
  - Formal ICH Procedure Helmut 2024-08-09 09:45
- ICH M13A: Changes to Step 2 Helmut 2024-09-06 08:04

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
- Handling and Retention of BA and BE Testing Samples Achievwin 2024-04-23 16:16

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FDA draft guidance on transdermal systems Ohlbe 2023-04-13 08:37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

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