Bioequivalence and Bioavailability Forum

Power TOST question Achievwin 2024-02-20 19:49 [Power / Sample Size]
- Power TOST question d_labes 2024-02-22 09:54
  - Power TOST question Achievwin 2024-02-22 18:34
    - Total sample size vs. vector of groups sizes Helmut 2024-02-23 10:06

CV in parallel design roman_max 2024-02-09 21:08 [🇷 for BE/BA]
- PowerTOST: CV in different designs Helmut 2024-02-10 00:30
  - PowerTOST: CV in different designs roman_max 2024-02-12 21:27
  - PowerTOST: CV in different designs roman_max 2024-02-13 19:38
    - Formulas for parallel and 2×2×2 designs Helmut 2024-02-13 20:55
      - Formulas for parallel and 2×2×2 designs roman_max 2024-02-15 16:42
  - PowerTOST: CV in different designs fethiye 2024-02-23 07:11

Tmax guideline Laura Carreiras 2024-02-16 15:05 [Regulatives / Guidelines]
- The minefield… Helmut 2024-02-16 15:59

sampleN.TOST vs. sampleN.scABEL BEQool 2024-01-29 11:53 [Power / Sample Size]
- ABEL is a framework (decision scheme) Helmut 2024-01-29 13:52
  - ABEL is a framework (decision scheme) BEQool 2024-01-30 10:52
    - ABEL vs. ABE Helmut 2024-01-30 13:08
      - ABEL vs. ABE BEQool 2024-02-04 19:24
        
        Being able to read does not hurt… Helmut 2024-02-04 21:12
        
        Being able to read does not hurt… BEQool 2024-02-05 13:20
        
        Being able to read does not hurt… Helmut 2024-02-05 16:01
        
        Vet BE Guideline mittyri 2024-02-05 16:49

power post hoc Imph 2024-01-29 19:24 [🇷 for BE/BA]
- post hoc power Helmut 2024-01-29 20:09
  - post hoc power Imph 2024-01-30 09:16
    - Tightening the limits reduces power for a given sample size Helmut 2024-01-30 09:43

Steady state BE study dosing NK 2024-01-19 04:24 [Design Issues]
- Circadian rhythm? Helmut 2024-01-20 12:50
- Steady state BE study dosing dshah 2024-01-22 10:09
  - AUC in steady state Helmut 2024-01-27 22:01
    - AUC in steady state dshah 2024-01-27 22:06
      - AUC in steady state Helmut 2024-01-27 22:16

multiple dose studies Loky do 2024-01-21 16:15 [Regulatives / Guidelines]
- multiple dose studies dshah 2024-01-22 10:03
  - Css level? dshah 2024-01-26 10:03

Statistical Method and acceptance Vismayi 2024-01-23 09:29 [Design Issues]

F-CAD BEQool 2024-01-23 07:40 [Software]

Subject effect justification Dafni_C 2024-01-17 10:00 [General Statistics]
- Subject effect justification Relaxation 2024-01-17 12:30

New EMA product specific guidance (PSG) SMA 2024-01-16 09:51 [BE/BA News]
- New EMA product specific guidance (PSG) dshah 2024-01-17 10:12

6th International Workshop – GBHI 2024: dates announced SMA 2023-08-30 10:11 [Conferences / Workshops]
- GBHI 6: Lodging Helmut 2023-08-30 19:06

In-vitro Population Bioequivalence (PBE) Parameters for Particle Size Distribution (PSD) balakotu 2024-01-06 12:23 [🇷 for BE/BA]

Go/No-go Decision for Pivotal Study NK 2023-12-27 12:15 [Power / Sample Size]
- Problematic T/R-ratio… Helmut 2023-12-27 13:27
  - TSD? Helmut 2024-01-01 13:50
    - sample size for TSD is better than for 1SD? mittyri 2024-01-01 19:54

Selection of points for Elimination rate constant ryraman2661 2023-12-23 08:41 [NCA / SHAM]
- Don’t include tmax Helmut 2023-12-23 11:46
  - Don’t include tmax ryraman2661 2023-12-26 08:40
    - Fishy Helmut 2023-12-26 15:30
      - Fishy ryraman2661 2023-12-28 12:19

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