Bioequivalence and Bioavailability Forum

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

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

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

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

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

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]

Half life longer than literature (or well known) half-life jag009 2023-12-06 04:19 [Study Assessment]
- Explain it in the report Helmut 2023-12-06 10:41
  - Explain it in the report jag009 2023-12-06 15:46
    - Don’t worry, be happy! Helmut 2023-12-06 16:30
      - Don’t worry, be happy! jag009 2023-12-07 16:36

Amlodipine/Valsartan Bebac user 2023-09-09 06:34 [Design Issues]
- Amlodipine/Valsartan Helmut 2023-09-12 06:48
  - Amlodipine/Valsartan Kumarnaidu2 2023-12-06 09:36
    - Amlodipine/Valsartan dshah 2023-12-06 16:49
      - Amlodipine/Valsartan Kumarnaidu2 2023-12-07 02:42
    - Use all data and avoid the partial replicate design for the FDA Helmut 2023-12-07 09:01

Ebastine study design Bebac user 2023-11-25 13:07 [Design Issues]
- Ebastine study design dshah 2023-11-27 09:53

ChatGPT generates fake data set to support scientific hypothesis Helmut 2023-11-24 08:10 [Off Topic]
- ChatGPT generates fake data set to support legal case Ohlbe 2023-11-24 15:57

Outlier in fully replicate BE study Loky do 2021-06-16 00:49 [Outliers]
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
  - Widening for clopidogrel BE study Loky do 2021-06-16 15:38
    - Widening for clopidogrel BE study mittyri 2021-06-16 16:04
      - Widening for clopidogrel BE study Loky do 2021-06-16 17:08
        
        Widening for clopidogrel BE study - cherry-picking? mittyri 2021-06-16 17:27
        Widening for clopidogrel BE study drgunasakaran1 2021-06-17 12:01
        Hypotheses Helmut 2021-06-19 12:32
        
        Hypotheses Loky do 2021-07-06 11:51
        
        ABEL ≠ RSABE Helmut 2021-07-06 16:17
        
        ABEL ≠ RSABE BEQool 2023-10-09 14:47
        
        power.TOST.sim and uncertainty mittyri 2023-10-11 12:42
        
        power.TOST.sim and uncertainty BEQool 2023-10-15 11:29
        
        power.TOST.sim and uncertainty mittyri 2023-10-20 21:47
        
        Distribution of PEs Helmut 2023-10-23 10:48
        
        Distribution of PEs BEQool 2023-10-23 19:55
        
        power.TOST.sim code mittyri 2023-10-31 15:40
        
        power.TOST.sim code BEQool 2023-11-02 11:22

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