Bioequivalence and Bioavailability Forum

Requesting data for a publication 📥 ♻️ 🚀 Helmut 2021-04-08 17:09📌
- Requesting data for another publication Helmut 2023-02-23 10:46

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- Outdated and wrong answers mittyri 2023-10-05 20:34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

Confidence intervals Bebac user 2022-12-19 13:59
- Confidence intervals PharmCat 2022-12-21 21:11

Observations in a linear model Helmut 2022-11-15 10:55
- Observations in a linear model ElMaestro 2022-11-16 08:44
  - Observations in a linear model Helmut 2022-11-16 09:49
    - Observations in a linear model ElMaestro 2022-11-16 20:50
      - And the Oscar goes to: Replicates! Helmut 2022-11-17 10:19
        
        It's all in the df's ElMaestro 2022-11-18 17:28

Parameter affecting Subject by formulation Mithu 2022-06-07 09:12

Defining time to concentration threshold Cytokrom C 2022-04-29 16:24
- Defining time to concentration threshold ElMaestro 2022-04-29 17:49
- I prefer interpolation Helmut 2022-04-29 19:03
  - I prefer interpolation Cytokrom C 2022-05-01 22:44
    - Continuous variable → mean Helmut 2022-05-02 00:05

IWRES and NPDE vs time/concentration plots interpretation jmt3 2022-04-03 08:25
- IWRES and NPDE vs time/concentration plots interpretation mittyri 2022-04-05 09:56

Adjusting weight to reflect group differences in Model balakotu 2022-03-29 11:24
- Adjusting weight to reflect group differences in Model dshah 2022-03-29 18:40
  - Adjusting weight to reflect group differences in Model Helmut 2022-03-30 11:07
    - Adjusting weight to reflect group differences in Model ElMaestro 2022-03-30 11:19

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