Bioequivalence and Bioavailability Forum

BioBridges 2023 Helmut 2023-04-06 10:52 [Conferences / Workshops]
- BioBridges 2023 - lectures available! mittyri 2023-10-31 16:33

Unusual / Distinct PK profile drug VijithRoy 2023-10-25 16:55 [PK / PD]
- Unusual / Distinct PK profile drug dshah 2023-10-26 15:36

Delayed Release Formulation -AUC truncated at 72 h (AUC(0-72h)) JP2030 2023-10-18 05:58 [Regulatives / Guidelines]
- EMA: No AUC(0-72h) for all MR products Helmut 2023-10-18 07:09

open-label BE trials maintain blindness kimhuang 2023-10-14 09:19 [Study Performance]
- Blinded NCA Helmut 2023-10-14 10:40
  - Blinded NCA kimhuang 2023-10-14 11:53
    - Blinded review of PK data: History… Helmut 2023-10-15 10:26
      - Blinded review of PK data: History… kimhuang 2023-10-16 00:43
- open-label BE trials maintain blindness ElMaestro 2023-10-14 17:39
  - open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
    - open-label BE trials maintain blindness dshah 2023-10-17 09:25
      - open-label BE trials maintain blindness kimhuang 2023-10-18 00:50

Application and test region of vasoconstrictor assay Kelen 2023-10-04 16:31 [Regulatives / Guidelines]
- Application and test region of vasoconstrictor assay dshah 2023-10-17 09:34

Tmax 90% confidence interval durga09 2023-09-08 10:21 [Regulatives / Guidelines]
- Tmax 90% confidence interval Achievwin 2023-09-09 12:44
  - link to the post of BEBAC golden collection mittyri 2023-09-10 19:55
    - link to the post of BEBAC golden collection durga09 2023-10-10 10:43
      - CI for difference in Tmax mittyri 2023-10-11 12:55
      - Tmax problems Helmut 2023-10-12 06:55

Carry over and statistical adjustment in BE computations Achievwin 2023-10-02 20:34 [General Statistics]
- Carry-over → 🚮 Helmut 2023-10-02 21:06
  - Carry-over → 🚮 Achievwin 2023-10-03 12:13
    - Carry-over → 🚮 Helmut 2023-10-03 12:48
    - Carry-over dshah 2023-10-03 16:34
      - Carry-over Achievwin 2023-10-03 20:33
        
        Carry-over Helmut 2023-10-04 08:31
        
        Carry-over Achievwin 2023-10-04 16:38
        
        Carry-over dshah 2023-10-04 11:22
      - more than 20% subject carry over effect investigation mittyri 2023-10-05 20:15
      - carry over effect investigation based on what? Helmut 2023-10-06 07:08
        
        carry over effect investigation based on what? dshah 2023-10-06 13:20
- Outdated and wrong answers mittyri 2023-10-05 20:34
  - Wrong answer Helmut 2023-10-06 07:19

Test License rajasekharkakarla 2018-10-06 08:05 [Regulatives / Guidelines]
- Test License Obinoscopy 2018-10-06 12:58
- Test License wienui 2018-10-07 21:04
  - Remaining RLDs from pilot study qualityassurance 2023-09-28 12:29
    - Remaining RLDs from pilot study wienui 2023-09-28 18:12
    - Remaining RLDs from pilot study- retention sample? dshah 2023-10-03 17:27

Pilot study data submission as pivotal study qualityassurance 2023-10-02 12:06 [Off Topic]
- Pilot study data submission as pivotal study dshah 2023-10-03 16:30

5th GBHI Conference Helmut 2021-02-02 16:26 [Conferences / Workshops]
- Conference report Helmut 2023-08-20 08:23
- Presentations Achievwin 2023-09-26 14:02
  - Presentations Helmut 2023-09-26 14:11

ICH M13A (IR BE) Helmut 2022-12-23 09:05 [BE/BA News]
- 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

Applied Course in Clinical Pharmacokinetics Helmut 2023-09-14 15:28 [Conferences / Workshops]

FDA Workshop Helmut 2023-09-11 12:53 [Conferences / Workshops]

WHO Draft on BCS-based Biowaivers Helmut 2023-08-29 11:18 [BE/BA News]

homoscedasticity assumption in RSABE method WinnieH 2023-08-18 08:57 [RSABE / ABEL]
- heteroscedasticity in RSABE (and ABEL) Helmut 2023-08-18 11:23
  - heteroscedasticity in RSABE (and ABEL) WinnieH 2023-08-18 13:05
- homoscedasticity assumption in RSABE method BEQool 2023-08-18 12:30
  - Asking a pupil d_labes 2023-08-18 14:11
    - Asking a pupil BEQool 2023-08-18 17:16

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