Bioequivalence and Bioavailability Forum

⚠️ Error 406 (in posting or replying) Helmut 2022-10-29 17:00 [Tips / Tricks]📌

Requesting data for a publication 📥 ♻️ 🚀 Helmut 2023-02-23 10:46 [General Statistics]📌

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

ICH M13B: Step 2b (draft for consultation) Helmut 2025-03-15 10:31 [BE/BA News]

Method Validation Loky do 2025-03-13 11:19 [Bioanalytics]
- HQC concentration Ohlbe 2025-03-14 17:13

ICH M13A complex study designs missing data and data excluded kimhuang 2025-03-04 08:12 [Regulatives / Guidelines]
- ICH M13A: Two-at-a-Time Helmut 2025-03-04 09:24
  - ICH M13A: Two-at-a-Time kimhuang 2025-03-07 00:46
    - ICH M13A: Descriptive statistics Helmut 2025-03-07 08:45
      - ICH M13A: Descriptive statistics kimhuang 2025-03-08 05:55

Bioequivalence study in Multiple countries Achievwin 2025-02-21 02:02 [Study Performance]
- Bioequivalence study in Multiple countries Achievwin 2025-03-07 19:02

BE study for Minoxidil jag009 2025-02-20 06:24 [Design Issues]
- FDA PSGs: Alternative approach Helmut 2025-02-20 10:44
- BE study for Minoxidil drgunasakaran1 2025-02-21 00:57
  - BE study for Minoxidil jag009 2025-03-01 03:20
    - BE study for Minoxidil ElMaestro 2025-03-01 20:29

2-period full replicate design for IR formulation – EMA perspective Ankit Parikh 2024-07-11 04:58 [Regulatives / Guidelines]
- 2-period full replicate design for IR formulation – EMA perspective BEQool 2025-03-01 12:33

Question about Williams Design Bebac user 2025-02-25 20:30 [Design Issues]

Significance The Outlaw Torn 2012-11-20 07:56 [Power / Sample Size]
- Significance ElMaestro 2012-11-20 08:17
  - Significance The Outlaw Torn 2012-11-20 08:55
    - Quality vs. Clinical ElMaestro 2012-11-20 09:04
- Sample size? Helmut 2012-11-20 20:10
  - Sample size? The Outlaw Torn 2012-11-21 07:52
  - Sample size? The Outlaw Torn 2012-11-22 10:55
    - Sample size, ratio, CV ↔ power Helmut 2012-11-22 13:35
      - Sample size, ratio, CV ↔ power The Outlaw Torn 2012-11-23 14:47
      - Sample size, ratio, CV ↔ power BEQool 2025-01-31 13:12
        
        TOST != treatment effect mittyri 2025-02-20 13:13
        Sample size, ratio, CV ↔ power zizou 2025-02-21 13:40
        
        Not vice versa mittyri 2025-02-22 21:08
        
        Not vice versa? zizou 2025-02-24 11:02
        
        Not vice versa? mittyri 2025-02-25 06:12
- Sample size calculation using Marzo and Balant method kumarnaidu 2013-01-31 07:48
  - Marzo / Balant formula d_labes 2013-01-31 10:05
    - Marzo / Balant formula kumarnaidu 2013-01-31 10:54
      - Marzo / Balant formula kumarnaidu 2013-02-04 05:48
        
        Marzo / Balant formula for parallel groups d_labes 2013-02-04 08:44

different ranks/levels of William design? Shuanghe 2025-02-12 00:46 [Design Issues]
- different ranks/levels of William design? BEQool 2025-02-19 11:34
- "ranking" William designs mittyri 2025-02-19 21:08
  - "ranking" William designs vezz 2025-02-20 14:23
  - "ranking" William designs Shuanghe 2025-02-23 11:47

Product Labelling Query professionalr 2025-02-18 22:01 [Regulatives / Guidelines]
- Product Labelling Query drgunasakaran1 2025-02-18 23:38

how to construct confidence interval for un-transformed metric? lizhao 2016-02-17 19:01 [Power / Sample Size]
- how to construct confidence interval for un-transformed metric? jag009 2016-02-17 20:43
- how to construct confidence interval for un-transformed metric? mittyri 2016-02-17 22:34
  - Fieller’s confidence interval Helmut 2016-02-18 13:38
    - Fieller’s confidence interval lizhao 2016-02-22 20:20
      - Fieller’s confidence interval yjlee168 2016-02-23 08:23
      - Rescue approaching – PowerTOST d_labes 2016-02-23 09:08
        
        Rescue approaching – PowerTOST Weidson 2024-11-28 23:15
        
        Why not base 🇷? Helmut 2024-12-03 13:39
        
        Why not base 🇷? Weidson 2025-02-15 20:42

Method A of EMA dshah 2025-02-10 07:27 [Software]
- ABEL: Why Excel? Helmut 2025-02-10 10:28
  - ABEL: Why Excel? dshah 2025-02-10 15:40

Admin contact
23,409 posts in 4,921 threads, 1,680 registered users;
18 visitors (0 registered, 18 guests [including 3 identified bots]).
Forum time: 10:04 CET (Europe/Vienna)

There are no routine statistical questions,
only questionable statistical routines. David R. Cox

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz