Bioequivalence and Bioavailability Forum

Requesting data for a publication 📥 ♻️ 🚀 Helmut 2021-04-08 17:09 [General Statistics]📌

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

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 Jan 16 2023 ElMaestro 2023-01-20 09:32 [Regulatives / Guidelines]

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

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

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

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
  - 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

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

Reference datasets Shatha 2022-12-22 12:45 [Software]

Confidence intervals Bebac user 2022-12-19 13:59 [General Statistics]
- Confidence intervals PharmCat 2022-12-21 21:11

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