Bioequivalence and Bioavailability Forum

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

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

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

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

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

Parallel Group Adaptive Designs Alex 2023-12-22 10:08 [Two-Stage / GS Designs]
- Strong Type I Error control + CI: Not yet… Helmut 2023-12-22 12:01
  - Strong Type I Error control + CI: Not yet… Alex 2024-01-08 16:22
    - Strong Type I Error control + CI: Not yet… Helmut 2024-01-09 09:48
  - Strong Type I Error control + CI: Not yet… roman_max 2024-04-04 15:18
    - Parallel design: Only simulation-based methods so far Helmut 2024-04-04 20:16
      - Parallel design: Only simulation-based methods so far roman_max 2024-04-15 21:46
- Parallel Group Adaptive Designs Achievwin 2024-01-05 11:53
  - Simulations highly recommended Helmut 2024-01-05 12:40
    - Simulations highly recommended Achievwin 2024-01-08 16:55
      - Simulations mandatory Helmut 2024-01-09 09:31
        
        Simulations mandatory Achievwin 2024-01-09 21:11
        
        Reviews are confidential Helmut 2024-01-09 22:10
        
        Reviews are confidential Achievwin 2024-01-19 15:11
        
        Not accepted and for a reason… Helmut 2024-04-04 20:22
        
        Quod licet Iovi mittyri 2024-04-05 20:33
        
        Non licet bovi Helmut 2024-04-05 21:50
        
        Non licet bovi mittyri 2024-04-05 22:21
        
        Quod licet bove? Helmut 2024-04-06 07:21

Mizolastine study design Bebac user 2023-12-20 18:47 [Design Issues]

Unannounced inspections, FDA ElMaestro 2023-12-19 08:54 [GxP / QC / QA]

Adaptive Design for the FDA’s RSABE? Helmut 2023-12-18 11:20 [Two-Stage / GS Designs]
- Likely it does not work (potentially inflated Type I Error) Helmut 2023-12-19 11:10
  - Exploring package adaptIVPT, function rss() Helmut 2023-12-20 13:27
    - Extreme test case Helmut 2023-12-24 13:01
      - Extreme GMR Naksh 2023-12-25 04:16
        
        PE outside {0.80, 1.25} not possible Helmut 2023-12-25 10:54
        
        PE outside {0.80, 1.25} not possible Naksh 2023-12-25 11:42
        
        Forget rss() Helmut 2023-12-25 13:15
        
        Forget rss() Naksh 2023-12-26 04:49
        
        TSD useful at all? Helmut 2023-12-26 12:50

update: bootf2BCA v1.3.2 is out at SourecForge yjlee168 2023-12-18 01:39 [Software]
- bootf2BCA - Folder does not exist? - Windows only (solved) yjlee168 2023-12-20 07:01

Single-dose study in patients Brus 2023-12-09 17:45 [Design Issues]
- Single-dose study in patients Helmut 2023-12-10 09:43
- Single-dose study in patients dshah 2023-12-11 10:44

FDA/PQRI Workshop about MR Helmut 2023-12-09 09:49 [Conferences / Workshops]

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