Bioequivalence and Bioavailability Forum

average bioequivalence: MLE vs. REML Mahmoud 2023-03-11 12:21 [General Statistics]
- 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

EUFEPS Open Forum: ICH M13 Draft Guideline Helmut 2023-03-05 12:50 [Conferences / Workshops]
- ICH M13 Draft Guideline: FDA webinar Ohlbe 2023-03-15 11:42

Pumas AI: new software for Pharmacokinetic Modeling Rayhope 2023-03-03 05:09 [Software]
- Pumas AI Helmut 2023-03-03 09:14
  - Pumas AI Rayhope 2023-03-10 05:23
    - Pumas AI PharmCat 2023-03-14 20:55

EU Transdermal Patch: Generic Submission HallaGulla 2023-03-08 08:58 [Design Issues]

Sample size for replicate crossover studies Imph 2023-03-06 14:29 [Power / Sample Size]
- Sample size for replicate crossover studies dshah 2023-03-06 15:40
- Sample size for replicate crossover studies Helmut 2023-03-06 16:48
  - Sample size for replicate crossover studies Imph 2023-03-07 11:30

Variance VS Coefficient of variation Imph 2023-02-27 09:09 [General Statistics]
- 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

In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-02-21 17:28 [Regulatives / Guidelines]
- In vitro binding study for sevelamer carbonate for Europe submission dshah 2023-02-22 16:40
  - In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-02-23 16:22
    - In vitro binding study for sevelamer carbonate for Europe submission dshah 2023-02-23 17:18
      - In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-02-24 15:24
        
        In vitro binding study for sevelamer carbonate for Europe submission dshah 2023-02-28 17:15
        
        In vitro binding study for sevelamer carbonate for Europe submission jansari 2023-03-01 15:34

Documentation of SS for LAI Achievwin 2023-02-06 13:40 [Design Issues]
- Documentation of SS for LAI dshah 2023-02-28 16:50

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]

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