Bioequivalence and Bioavailability Forum

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

EMA: Guideline on computerised systems and electronic data in clinical trials Helmut 2021-06-30 10:41
- Validation! mittyri 2021-06-30 16:26

WHO guideline on data integrity Ohlbe 2021-04-08 11:03

FDA: ANDA during COVID-19 pandemic Helmut 2021-01-19 17:27

WHO frequent deficiencies in protocols and reports Ohlbe 2020-12-04 12:04
- WHO frequent deficiencies in protocols and reports ElMaestro 2020-12-04 14:10
  - CI inclusion ≠ TOST Helmut 2020-12-04 20:30
    - CI inclusion ≠ TOST d_labes 2020-12-05 16:19
      - CI inclusion ≠ TOST ElMaestro 2020-12-05 16:49
        
        CI inclusion ≠ TOST d_labes 2020-12-07 11:39
      - CI inclusion ≠ TOST Helmut 2020-12-06 22:09
        
        CI inclusion operationally identical to TOST d_labes 2020-12-07 11:11
        
        WHO lamenting about terminology? Helmut 2020-12-07 13:02
        
        WHO lamenting about terminology? ElMaestro 2020-12-07 14:54
        WHO lamenting about terminology? d_labes 2020-12-07 15:35
- WHO frequent deficiencies in protocols and reports Helmut 2020-12-22 19:00
  - "obtain balanced groups" vs randomisation ElMaestro 2020-12-23 08:12

Dasatinib EMA, April 2020 ElMaestro 2020-06-21 11:49
- What a relief! Helmut 2020-06-21 14:12

Any CROs open for BA/BE studies in US/Europe/India Achievwin 2020-04-25 00:24
- Any CROs open for BA/BE studies in US/Europe/India jag009 2020-04-28 17:29
  - Any CROs open for BA/BE studies in US/Europe/India BRB 2020-04-30 17:41
    - Any CROs open for BA/BE studies in US/Europe/India jag009 2020-05-02 04:38
      - Any CROs open for BA/BE studies in US/Europe/India BRB 2020-05-04 16:44
      - Any CROs open for BA/BE studies in US/Europe/India Achievwin 2020-05-07 03:23
- Any CROs open for BA/BE studies in US/Europe/India Relaxation 2020-04-28 19:26
  - Any CROs open for BA/BE studies in US/Europe/India Ohlbe 2020-04-28 19:33

Russia: Changed procedure for determining drug interchangeability Helmut 2020-02-21 13:20
- Russia: Changed procedure for determining drug interchangeability Beholder 2020-02-21 15:05

ICH M13 Helmut 2019-11-27 19:08
- ICH M13 ElMaestro 2019-11-27 21:42
  - ICH pushed by GBHI? Helmut 2019-11-28 12:37
    - ICH pushed by GBHI? Ohlbe 2019-11-28 14:06
      - “Lively” discussions Helmut 2019-11-28 14:23
        
        M9 step 4 now published Ohlbe 2019-12-04 11:26
        
        And Japan? Helmut 2019-12-04 11:42
        
        And Japan? ElMaestro 2019-12-04 14:43
        
        ? business as usual Helmut 2019-12-04 15:42

September 2019: 34 new and 19 revised product-specific FDA BE guidelines nobody 2019-09-24 10:58

BE in hepatic impairment? nobody 2019-08-30 09:29

ICH E8(R1) step 2b Helmut 2019-06-03 10:02
- ICH E8(R1) step 2b ElMaestro 2019-06-03 23:18
  - ICH E8(R1) step 2b Ohlbe 2019-06-04 04:03

FDA Web page Rosy 2019-05-03 16:28
- Redesign of the FDA’s site: A rant ☠ Helmut 2019-05-03 17:28

WHO Questions and Answers: similar biotherapeutic products Helmut 2019-04-15 00:25

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