Bioequivalence and Bioavailability Forum

ANVISA Guidelines on Participant Involvement in Clinical Trials Rajul9 2024-11-24 18:19 [Regulatives / Guidelines]
- ANVISA Guidelines on Participant Involvement in Clinical Trials drgunasakaran1 2025-01-13 13:13

Interim Safety Analysis or Re-Screening professionalr 2025-01-09 22:56 [Design Issues]
- Interim Safety Analysis or Re-Screening drgunasakaran1 2025-01-10 00:01

Population BE [PBE] jdfr 2024-12-05 16:34 [Regulatives / Guidelines]
- Population BE [PBE] ElMaestro 2024-12-17 22:50
  - Population BE [PBE] jdfr 2025-01-06 11:14
    - Population BE [PBE] ElMaestro 2025-01-06 12:52
      - Population BE [PBE] jdfr 2025-01-07 12:08
        
        Population BE [PBE] ElMaestro 2025-01-07 13:50
        
        Population BE [PBE] jdfr 2025-01-07 17:10
        
        Population BE [PBE] ElMaestro 2025-01-07 18:55
        
        Population BE [PBE] jdfr 2025-01-08 10:13
        
        Population BE [PBE] ElMaestro 2025-01-08 11:02
        
        Population BE [PBE] jdfr 2025-01-08 17:45
        Population BE [PBE] jdfr 2025-01-09 09:16
        
        Population BE [PBE] ElMaestro 2025-01-09 14:46

Do regulatory agencies accept steady-state equivalence studies? libaiyi 2024-12-04 08:34 [Design Issues]
- HVD(P)s: steady state = history Helmut 2024-12-04 09:37
  - HVD(P)s: steady state = history libaiyi 2024-12-04 09:52
    - HVD(P)s: steady state = history dshah 2024-12-05 07:22
- Do regulatory agencies accept steady-state equivalence studies? xtianbadillo 2024-12-16 20:59
  - steady-state in patients Helmut 2024-12-17 09:45
    - steady-state in patients qualityassurance 2025-01-09 10:59

Clinical strategy for generic of biosimilar qualityassurance 2025-01-09 08:41 [Regulatives / Guidelines]

Group-by-Treatment Interaction: the final word? Helmut 2024-04-19 01:26 [General Statistics]
- Group-by-Treatment Interaction: FDA Helmut 2024-09-20 13:30
  - Group-by-Treatment Interaction: Rejoinder Helmut 2024-12-17 10:26
- Group-by-Treatment Interaction: the final word? BEQool 2024-10-03 15:09
  - ANOVA of Model 1 Helmut 2024-10-03 15:33
    - ANOVA of Model 1 BEQool 2024-10-03 16:08
      - ANOVA of Model 1 Helmut 2024-10-04 10:11
        
        Between vs Within mittyri 2024-10-05 00:08
        
        Between vs Within BEQool 2024-10-06 20:06
        
        Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-06 22:00
        
        Treatment-by-Group in PROC MIXED and PROC GLM? BEQool 2024-10-07 10:27
        
        Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-07 13:11
        
        Treatment-by-Group in PROC MIXED and PROC GLM? BEQool 2024-10-14 11:01

Outlier Test using R-Software and Phoenix WinNonlin software in the BE udayk 2020-03-06 09:00 [Outliers]
- Outlier Test using R-Software and Phoenix WinNonlin software in the BE ping4santosh 2020-03-11 14:58
- Studentized & standardized residuals Helmut 2020-03-13 11:21
- Outlier Test using R-Software: Lund test ping4santosh 2020-03-14 14:52
  - Outlier Test using R-Software: Lund test udayk 2020-03-20 07:05
    - Outlier Test using R-Software: Lund test ping4santosh 2020-03-20 10:07
- bear for outlier detection analysis? yjlee168 2020-03-20 14:45
  - bear for outlier detection analysis? xtianbadillo 2024-12-16 20:44

Recovery testing Rasha 2024-12-16 10:29 [Bioanalytics]
- FDA: ICH M10 implemented in November 2022 Helmut 2024-12-16 12:38
  - FDA: ICH M10 implemented in November 2022 Rasha 2024-12-16 13:15

Questions about "sequence effect" mentioned in a FDA PSG Darborn 2024-12-10 11:04 [General Statistics]

Mixed effects model: ML or REML Mahmoud 2024-12-05 11:20 [General Statistics]

3rd Bioequivalence Conference 26 Feb 2025 in Amsterdam SMA 2024-11-28 11:33 [Conferences / Workshops]

ISR Loky do 2024-11-21 12:04 [Study Assessment]
- ISR qualityassurance 2024-11-21 13:53
  - ISR Loky do 2024-11-22 12:16
    - ISR dshah 2024-11-27 12:46
    - ISR qualityassurance 2024-11-27 14:27

First Point Cmax USFDA NK 2024-09-13 06:48 [Study Assessment]
- First Point Cmax (also ICH M13A) Helmut 2024-09-17 08:38
  - First Point Cmax (also ICH M13A) kimhuang 2024-11-27 08:49
    - FDA M13A Helmut 2024-11-27 13:50
- First Point Cmax (also ICH M13A) dshah 2024-11-27 12:50

Group-by-Treatment Interaction (another round) Helmut 2024-11-27 12:01 [Study Assessment]

Possible reasons for group effect GM 2019-07-20 07:36 [Design Issues]
- Group “effect” Helmut 2019-07-20 14:02
- Possible reasons for group effect ElMaestro 2019-07-20 19:20
  - Possible reasons for group effect GM 2019-07-23 06:23
    - “Group-by-Treatment Interaction” Helmut 2019-07-23 10:32
      - “Group-by-Treatment Interaction” BEQool 2024-10-22 12:39
        
        “Group-by-Treatment Interaction” Helmut 2024-10-22 12:47
        
        OT: A choice between mittyri 2024-10-22 16:03
        
        OT: A choice between BEQool 2024-10-23 11:02
        
        OT: A choice between Helmut 2024-10-23 11:58
        
        OT: A choice between BEQool 2024-10-23 13:17
        
        OT: A choice between Helmut 2024-10-23 13:22
        Groups: Overlapping CIs Helmut 2024-11-03 11:36
        
        Groups: Overlapping CIs BEQool 2024-11-05 09:14
        
        Groups: Overlapping CIs Helmut 2024-11-05 10:12
        
        Groups: Overlapping CIs BEQool 2024-11-06 07:44
        
        Groups: (Hardly‽) overlapping CIs Helmut 2024-11-21 13:20
        
        Groups: (Hardly‽) overlapping CIs BEQool 2024-11-22 12:32
        
        Groups: (Hardly‽) overlapping CIs Helmut 2024-11-22 12:58
        Multiplicity? Helmut 2024-11-23 13:05
        
        Groups BEQool 2024-11-26 08:15

Admin contact
23,424 posts in 4,927 threads, 1,668 registered users;
144 visitors (0 registered, 144 guests [including 10 identified bots]).
Forum time: 15:21 CEST (Europe/Vienna)

Freedom is always and exclusively
freedom for the one
who thinks differently. Rosa Luxemburg

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz