Bioequivalence and Bioavailability Forum

Are Statistical Analysis Plans “required” for Pivotal Studies? Sereng 2023-02-08 18:23 [General Statistics]
- 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 [General Statistics]
- 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

Tmax in Partial Replicate Design Joshua 2012-01-17 06:59 [Nonparametrics]
- Good question! Helmut 2012-01-17 11:34
  - Good question! Joshua 2012-01-20 11:54
    - Early exposure (+scaling?) Helmut 2012-01-20 12:56
- Tmax in Partial replicate design d_labes 2012-01-20 11:12
  - Tmax in Partial replicate design Joshua 2012-01-20 12:09
    - Intra-subject contrast (difference) d_labes 2012-01-20 12:55
      - Intra-subject contrast (difference) Joshua 2012-01-20 13:01
      - Wilcoxon for 2x2x4. "Not many things easier than that"? Astea 2023-02-14 18:44
  - Tmax in Partial replicate design mittyri 2017-01-03 23:24
    - ISC and Wilcoxon signed rank test d_labes 2017-01-04 10:21
      - ISC and Wilcoxon signed rank test in coin package mittyri 2017-01-04 14:17
        
        ISC and Wilcoxon signed rank test in coin package d_labes 2017-01-04 16:09

Deconvolution sample size and design issues mittyri 2023-02-09 14:40 [Power / Sample Size]
- Deconvolution sample size and design issues dshah 2023-02-09 16:20
  - Deconvolution sample size and exponential terms mittyri 2023-02-09 22:08
    - Deconvolution sample size and exponential terms dshah 2023-02-10 09:34

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

Biowaiver for site transfer in Mexico jag009 2023-01-17 14:57 [Regulatives / Guidelines]
- Biowaiver for site transfer in Mexico Ricardo 2023-02-08 01:59

Suitability System Test? niel 2023-02-05 09:27 [Bioanalytics]

Study Design- Two treatment or Four treatment NK 2023-01-23 09:38 [Design Issues]
- Study Design- Two treatment or Four treatment dshah 2023-01-23 10:43
  - Study Design- Two treatment or Four treatment NK 2023-01-24 03:37
- Study Design- Two treatment or Four treatment ElMaestro 2023-01-23 15:05
  - Study Design- Two treatment or Four treatment Relaxation 2023-01-23 16:10

IMP retention quantity requirement for Japan market Rahul Metangale 2023-01-23 11:31 [Regulatives / Guidelines]

M10 Q&A dated 16 Jan 2023 ElMaestro 2023-01-20 09:32 [Regulatives / Guidelines]

Medicines for Europe: 2nd BE Workshop Helmut 2022-12-10 09:43 [Conferences / Workshops]
- Medicines for Europe: 2nd BE Workshop ElMaestro 2022-12-10 14:48
- Medicines for Europe: 2nd BE Workshop SMA 2023-01-18 09:48

Questions on understanding the 4-way RSABE method SAS code WinnieH 2023-01-04 13:33 [RSABE / ABEL]
- Questions on understanding the 4-way RSABE method SAS code Helmut 2023-01-04 14:02
  - Questions on understanding the 4-way RSABE method SAS code WinnieH 2023-01-04 15:12

FDA's HVD SAS Code / Standard Error / CV j_kevin 2022-12-08 09:41 [Regulatives / Guidelines]
- FDA's HVD SAS Code / Standard Error / CV Helmut 2022-12-08 12:09
  - FDA's HVD SAS Code / Standard Error / CV j_kevin 2022-12-09 07:28
    - CV limbo Helmut 2022-12-09 13:36
      - CV limbo ElMaestro 2022-12-09 15:49
      - CV limbo j_kevin 2022-12-14 13:12
      - CV limbo j_kevin 2023-01-02 03:06
      - CV limbo j_kevin 2023-01-02 05:07
        
        CV limbo Helmut 2023-01-04 11:39

Chili guidelines gsrao2022 2022-12-25 16:17 [Regulatives / Guidelines]
- ANAMED Helmut 2022-12-27 09:42

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

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If there is an exception to any rule,
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