Bioequivalence and Bioavailability Forum

⚠️ Read before registering Helmut 2016-04-14 23:39 [Tips / Tricks]📌

Bioequivalence Acceptance criteria for in-vitro binding study in EMA submission Biostats 2020-01-24 08:19 [Regulatives / Guidelines]

FDA: required BE between early phase and Phase 3 formulations? fno 2020-01-22 15:38 [Regulatives / Guidelines]
- no BE between early phase and Phase 3 formulations Helmut 2020-01-22 16:15
  - no BE between early phase and Phase 3 formulations fno 2020-01-22 17:11
    - relax Helmut 2020-01-23 11:59
      - Thanks! fno 2020-01-23 14:48

Higher-order crossovers sweiner 2020-01-22 20:22 [Power / Sample Size]
- Purpose of the study? Helmut 2020-01-23 13:48

What are we doing here? nobody 2020-01-20 10:20 [Off Topic]
- What are we doing here? ElMaestro 2020-01-20 10:32
  - What are we doing here? Helmut 2020-01-20 15:52
  - What are we doing here? nobody 2020-01-20 16:23

Sample size calculations GM 2020-01-17 13:42 [Power / Sample Size]
- Sample size calculations Helmut 2020-01-18 01:31
  - Sample size calculations GM 2020-01-20 06:59

R in regulated environments Helmut 2019-08-28 14:58 [R for BE/BA]
- FDA, again Helmut 2020-01-09 16:04

Steady State Bioequivalence Study Pharma_88 2020-01-08 10:07 [Design Issues]
- Pre-dose samples Helmut 2020-01-09 12:36

3+3 Design Pharma_88 2020-01-07 08:09 [Design Issues]
- 3+3 Design Ohlbe 2020-01-07 11:25
  - 3+3 Design Pharma_88 2020-01-08 09:55
    - Subject replacement Ohlbe 2020-01-08 10:41
- Dose escalation and DMC Helmut 2020-01-07 12:18
  - Dose escalation and DMC Pharma_88 2020-01-08 09:56

The same PI for two studies in the same time wienui 2020-01-05 18:22 [Study Assessment]
- The same PI for two studies in the same time ElMaestro 2020-01-05 21:38
  - The same PI for two studies in the same time wienui 2020-01-06 04:05
    - The same PI for two studies in the same time Ohlbe 2020-01-06 12:27
      - The same PI for two studies in the same time Helmut 2020-01-06 13:34

Normal Reference Range Vs Pre-defined site normal values cakhatri 2019-12-17 11:35 [Design Issues]
- Normal Reference Range Vs Pre-defined site normal values ElMaestro 2019-12-17 23:21
- Hb level Ohlbe 2019-12-29 17:04
  - OT Helmut 2019-12-29 18:49
  - Hb level nobody 2019-12-31 10:47
  - Hb level ElMaestro 2019-12-31 15:19
    - Hb level nobody 2019-12-31 15:46
      - Hb level ElMaestro 2019-12-31 17:21
        
        Hb level nobody 2019-12-31 17:26
        Participation databases Helmut 2019-12-31 18:01
        
        Participation databases ElMaestro 2019-12-31 20:21
        
        Participation databases Helmut 2020-01-01 10:23
        
        Participation databases ElMaestro 2020-01-01 12:23
        
        Participation databases nobody 2020-01-02 10:35
        Participation databases Ohlbe 2020-01-02 12:18
        
        National databases‽ Helmut 2020-01-02 13:06
        
        Great discussion ElMaestro 2020-01-02 16:31
        
        Great discussion Ohlbe 2020-01-02 16:57
        
        Great discussion ElMaestro 2020-01-02 18:19
        
        WTF 😡 Helmut 2020-01-02 18:42
        
        Great discussion Helmut 2020-01-02 17:14
        
        National databases‽ Ohlbe 2020-01-02 16:36

Bioequivalence of racemic drugs using non-steriospecific bio scorp2011 2012-01-12 13:21 [Regulatives / Guidelines]
- BE of racemic drugs (EMA vs. FDA) Helmut 2012-01-12 19:21
  - BE of racemic drugs (EMA vs. FDA) scorp2011 2012-01-13 06:11
    - BE of racemic drugs (EMA’s practice) Helmut 2012-01-13 16:02
      - BE of racemic drugs (EMA’s practice) scorp2011 2012-01-16 13:08
        
        BE of racemic drugs (EMA’s practice) valivetiananth 2019-12-30 13:45
        
        BE of racemic drugs (EMA’s practice) Helmut 2019-12-30 14:35

Group by sequence interaction Mutasim 2019-08-07 13:16 [General Statistics]
- Group by sequence interaction, an urban myth? Helmut 2019-08-07 14:35
  - pristine, genuine, holy, magnificent, inexplicable beautiful variation ElMaestro 2019-08-08 10:06
    - I love your subject line! Helmut 2019-08-08 10:31
      - Group effect, did you miss it? Astea 2019-12-21 14:12
        
        Group effect, did you miss it? PharmCat 2019-12-22 01:37
        Group effect: the endless story Helmut 2019-12-22 10:30
        
        Group effect: the endless river Astea 2019-12-22 21:23
        
        Group effect: the endless river PharmCat 2019-12-22 22:52
        replicateBE solution with interactions mittyri 2019-12-23 14:30
        
        replicateBE solution with interactions Astea 2019-12-23 17:26
        
        datasets issues mittyri 2019-12-24 10:53
        datasets Helmut 2019-12-24 11:03
        
        datasets Astea 2019-12-24 19:18
        
        lmer / lme Helmut 2019-12-25 19:12
        
        What do you mean exactly? Beholder 2019-12-27 13:44
        
        What do you mean exactly? Astea 2019-12-29 21:59
        
        ANOVA acc. to GL Helmut 2019-12-30 12:32

Should those subjects have only one period data be included in BE analysis? ssussu 2019-12-06 10:58 [Design Issues]
- No way! But... Beholder 2019-12-06 12:36
  - No way! But... ElMaestro 2019-12-06 13:14
    - No way! But... Helmut 2019-12-06 14:47
      - No way! But... PharmCat 2019-12-06 23:46
        
        No way! But... wienui 2019-12-07 04:01
        
        EMA guideline: no way...: mittyri 2019-12-07 20:58
        
        EMA guideline: no way...: wienui 2019-12-09 05:25
        
        Slightly off topic, but related :-) ElMaestro 2019-12-08 01:31
        
        Slightly off topic, but related :-) Shuanghe 2019-12-09 12:00
        Slightly off topic, but related :-) PharmCat 2019-12-09 15:13
        
        Slightly off topic, but related :-) ElMaestro 2019-12-21 15:02
        
        Slightly off topic, but related :-) PharmCat 2019-12-22 01:12
        2.220446e-16 ≈ 0 Helmut 2019-12-22 10:37
        
        The optional tolerance argument ElMaestro 2019-12-23 14:37
        2.220446e-16 ≈ 0 PharmCat 2019-12-24 14:18
        
        Sum of residuals ~ ε Helmut 2019-12-24 14:54
        
        Sum of residuals ~ ε ElMaestro 2019-12-24 15:10
        
        Wrong terminology Helmut 2019-12-28 13:55
        
        Sum of residuals ~ ε PharmCat 2019-12-24 18:40

Run R-packages in the browser Helmut 2019-12-20 11:17 [R for BE/BA]
- Run R-packages in the browser Shuanghe 2019-12-20 12:39
  - Run R-packages in the browser Helmut 2019-12-20 13:45
  - Run R-packages in the browser ElMaestro 2019-12-20 21:49

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