Bioequivalence and Bioavailability Forum

Definition of Full Replicate Sereng 2023-03-13 17:08 [Design Issues]
- Definition of Full Replicate Mahmoud 2023-03-13 20:27
  - Definition of Full Replicate Sereng 2023-03-13 23:38
    - Definition of Full Replicate Mahmoud 2023-03-14 08:44
      - Definition of Full Replicate Achievwin 2023-03-27 19:08
        
        Full Replicate with 3 periods mittyri 2023-03-27 22:16
        
        Full Replicate with 3 periods Achievwin 2023-03-28 03:06
        Full Replicate with 3 periods Helmut 2023-03-28 09:03
- Definition of Full Replicate Brus 2023-03-14 10:10
- Replicate Design ≠ Higher-Order Crossover Helmut 2023-03-14 10:37
  - Thank You! Sereng 2023-03-14 20:08
  - Replicate Design ≠ Higher-Order Crossover Relaxation 2023-03-20 08:56
    - imbalance in Latin Square mittyri 2023-03-27 23:01
    - Balance for all effects Helmut 2023-04-21 10:01

Chili guidelines gsrao2022 2022-12-25 16:17 [Regulatives / Guidelines]
- ANAMED Helmut 2022-12-27 09:42
  - ANAMED Pharma_88 2023-04-19 04:57

Oxcarbazepine Tablet Fasting and Fed AB661 2023-04-15 07:47 [Regulatives / Guidelines]

FDA draft guidance on transdermal systems Ohlbe 2023-04-13 08:37 [BE/BA News]

CI.BE in PowerTOST BEQool 2023-03-31 10:05 [🇷 for BE/BA]
- Bug in PowerTOST:CI.BE Helmut 2023-03-31 11:41
  - Bug in PowerTOST:CI.BE BEQool 2023-04-03 05:38

New guidance on Statistical Approaches to Establishing Bioequivalence Relaxation 2022-12-02 15:53 [BE/BA News]
- A first look Helmut 2022-12-02 16:43
  - A first look jag009 2022-12-02 17:58
    - A first look BRB 2022-12-02 18:20
  - SAS strikes back mittyri 2022-12-02 20:38
    - SAS strikes back Helmut 2022-12-02 22:30
      - Outliers? mittyri 2022-12-02 22:52
        
        Outliers? Helmut 2022-12-02 23:11
      - SAS strikes back Achievwin 2023-02-07 07:23
  - model-based BE? mittyri 2022-12-07 16:26
    - model-based BE? Helmut 2022-12-10 10:13
      - Hooker, Moellenhoff et al. are moving MBBE forward mittyri 2023-01-11 15:32
      - model-based BE? SMA 2023-01-17 09:41
  - A first look PharmCat 2022-12-21 19:30
  - A first look Rayhope 2023-01-06 06:56
- Groups, sites… Helmut 2022-12-03 13:09
- SxF ElMaestro 2022-12-04 06:34
  - SxF Helmut 2022-12-10 10:37
- New guidance on Statistical Approaches to Establishing Bioequivalence Mahmoud 2022-12-10 14:08
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13
    - Multi-group studies ad nauseam Helmut 2023-02-07 11:30
      - Multi-group studies ad nauseam Achievwin 2023-02-25 16:18
    - Webinar: Recording available Helmut 2023-04-01 10:38
  - Speed kills Helmut 2023-02-07 13:02

where can I find Old FDA PSG Achievwin 2023-03-24 14:51 [Regulatives / Guidelines]
- where can I find Old FDA PSG Ohlbe 2023-03-25 17:03
  - where can I find Old FDA PSG Achievwin 2023-03-27 02:10

UK/EU IMP Labelling requirement for Comparator used in BE studies HallaGulla 2023-03-22 12:34 [Regulatives / Guidelines]
- UK/EU IMP Labelling requirement for Comparator used in BE studies Ohlbe 2023-03-24 13:59

Upper confidence bound and confidence interval of RSABE WinnieH 2023-03-21 10:58 [RSABE / ABEL]

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

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A statistical analysis, properly conducted, is a delicate dissection of
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