Bioequivalence and Bioavailability Forum

Requesting data for a publication 📥 ♻️ 🚀 Helmut 2023-02-23 10:46📌

Group-by-Treatment Interaction: the final word? Helmut 2024-04-19 01:26
- 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

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

Mixed effects model: ML or REML Mahmoud 2024-12-05 11:20

Question about computing 90% CI w data from 2 separate studies jag009 2024-10-14 01:44
- Question about computing 90% CI w data from 2 separate studies dshah 2024-10-14 08:38
  - Question about computing 90% CI w data from 2 separate studies jag009 2024-10-14 15:40
- Question about computing 90% CI w data from 2 separate studies BEQool 2024-10-14 11:37
  - Question about computing 90% CI w data from 2 separate studies jag009 2024-10-14 15:45
    - Question about computing 90% CI w data from 2 separate studies BEQool 2024-10-18 12:03
  - Question about computing 90% CI w data from 2 separate studies dshah 2024-10-15 06:11

Standard deviation of different designs BEQool 2024-06-27 12:25
- Standard deviation of different designs Helmut 2024-06-27 13:29
  - Standard deviation of different designs BEQool 2024-06-28 07:35
- Standard deviation of different designs ElMaestro 2024-06-29 22:08
  - Standard deviation of different designs BEQool 2024-07-01 07:25
    - Standard deviation of different designs ElMaestro 2024-07-01 07:38
      - Standard deviation of different designs BEQool 2024-07-01 08:41
        
        Standard deviation of different designs mittyri 2024-07-01 11:18
  - Standard deviation of different designs ElMaestro 2024-07-03 13:37

Subject effect justification Dafni_C 2024-01-17 10:00
- Subject effect justification Relaxation 2024-01-17 12:30

Carry over and statistical adjustment in BE computations Achievwin 2023-10-02 20:34
- 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

Calculation of PE and 90% CI Brus 2023-06-14 16:34
- No ‘R1’ and ‘R2’ in replicate designs Helmut 2023-06-14 22:26
  - No ‘R1’ and ‘R2’ in replicate designs Brus 2023-06-15 14:07
    - Rose is a rose is a rose is a rose Helmut 2023-06-15 14:49
    - No ‘R1’ and ‘R2’ in replicate designs Achievwin 2023-06-19 19:42

within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-08 13:54
- within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-08 16:35
  - within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-09 07:15
    - within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-14 09:26
      - within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-14 09:33
        
        within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-14 10:37

average bioequivalence: MLE vs. REML Mahmoud 2023-03-11 12:21
- average bioequivalence: MLE vs. REML PharmCat 2023-03-14 20:44
  - average bioequivalence: MLE vs. REML Mahmoud 2023-03-15 08:35
    - average bioequivalence: MLE vs. REML PharmCat 2023-03-16 23:51

Variance VS Coefficient of variation Imph 2023-02-27 09:09
- s² ↔ CV Helmut 2023-02-27 13:00
  - CV ≈ s for low variances mittyri 2023-02-27 20:45
    - CV ≈ s for low variances Helmut 2023-02-28 10:24
      - CV ≈ s for low variances Imph 2023-03-06 12:42

Are Statistical Analysis Plans “required” for Pivotal Studies? Sereng 2023-02-08 18:23
- SAP vs. part of the clinical protocol Helmut 2023-02-09 09:49
  - SAP vs. part of the clinical protocol Sereng 2023-02-10 23:34
    - Traceability Helmut 2023-02-11 13:22
- Are Statistical Analysis Plans “required” for Pivotal Studies? Achievwin 2023-02-15 12:07
- Are Statistical Analysis Plans “required” for Pivotal Studies? ElMaestro 2023-02-16 06:55

Pharmacokinetic and statistical analysis in bioequivalence while maintaining the blind Imph 2023-02-12 08:31
- Blinded NCA in Phoenix/WinNonlin Helmut 2023-02-12 08:45
  - Blinded NCA in Phoenix/WinNonlin Imph 2023-02-12 09:08
    - Blinded NCA in Phoenix/WinNonlin Helmut 2023-02-12 09:21
- Pharmacokinetic and statistical analysis in bioequivalence while maintaining the blind ElMaestro 2023-02-13 15:07
  - Phoenix: Locked Workflows Helmut 2023-02-13 16:08
    - Phoenix: Locked Workflows Imph 2023-02-14 13:51
      - Blind forever? Helmut 2023-02-14 14:00
        
        Blind forever? Imph 2023-02-15 11:00

How to calculate Within-subject variability in a replicated BE Brus 2022-12-25 09:21
- Models, models! Helmut 2022-12-25 12:17

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Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body. Leslie Z. Benet

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Ing. Helmut Schütz