Bioequivalence and Bioavailability Forum

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

Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology suchit_bhavsar 2022-06-29 07:37 [Regulatives / Guidelines]

BMI Loky do 2022-06-26 17:05 [Regulatives / Guidelines]
- BMI in the protocol Helmut 2022-06-26 17:19
  - BMI in the protocol Loky do 2022-06-29 11:11

T1E after 1st stage in Power2Stage mittyri 2022-06-24 13:43 [Two-Stage / GS Designs]
- T1E after 1st stage in TSDs Helmut 2022-06-24 14:33
  - T1E after 1st stage in TSDs mittyri 2022-06-24 21:12
    - T1E after 1st stage in TSDs Helmut 2022-06-25 14:07
      - Potvin C consequences mittyri 2022-06-25 23:29
        
        Potvin C consequences ElMaestro 2022-06-26 09:11
        
        Potvin C consequences mittyri 2022-06-27 13:45
        
        Potvin C consequences Helmut 2022-06-27 14:49
        
        from Potvin C to Inverse Normal mittyri 2022-06-27 17:13
        
        from Potvin C to Inverse Normal (history) Helmut 2022-06-27 18:54
        
        Potvin C consequences ElMaestro 2022-06-27 17:13
        
        true CV ≠ observed CV mittyri 2022-06-27 17:22
- T1E after 1st stage in Power2Stage ElMaestro 2022-06-24 18:25
  - T1E after 1st stage in Power2Stage mittyri 2022-06-24 21:05
    - T1E after 1st stage in Power2Stage ElMaestro 2022-06-24 22:55

PK time points Vaibhav 2022-06-23 21:31 [Design Issues]
- PK time points dshah 2022-06-24 11:29

Unequal variances in parallel design Imph 2022-06-20 16:16 [Regulatives / Guidelines]
- Welch’s t-test Helmut 2022-06-20 16:47
  - Welch’s t-test Imph 2022-06-23 13:02
    - Welch’s t-test Helmut 2022-06-23 14:19
      - Welch’s t-test Imph 2022-06-26 10:06
        
        Read the paper, use the code(s)! Helmut 2022-06-26 12:12

Regulatory acceptance pre-mature discontinuation of study Vaibhav 2022-06-20 15:07 [Study Performance]
- Regulatory acceptance pre-mature discontinuation of study Helmut 2022-06-20 16:13
  - Regulatory acceptance pre-mature discontinuation of study Vaibhav 2022-06-21 14:26
    - Regulatory acceptance pre-mature discontinuation of study Helmut 2022-06-21 15:12
      - Regulatory acceptance pre-mature discontinuation of study dshah 2022-06-23 12:52
        
        Regulatory acceptance pre-mature discontinuation of study Vaibhav 2022-06-23 20:41

Retraction Helmut 2022-06-16 14:43 [Off Topic]
- Retraction ElMaestro 2022-06-16 17:52
  - Retraction Helmut 2022-06-16 18:05

scale average bioequivalence for parallel design Mahmoud 2022-06-15 12:33 [RSABE / ABEL]
- Parallel design: Maybe (‼) in exceptional cases Helmut 2022-06-15 14:08
  - Parallel design: Maybe (‼) in exceptional cases Mahmoud 2022-06-15 23:26

BE study results Evaluation Vaibhav 2022-06-14 20:57 [Study Assessment]
- Sample size based on ‘overpowered’ study Helmut 2022-06-14 22:14
  - Sample size based on ‘overpowered’ study Vaibhav 2022-06-15 21:00
    - Sample size based on ‘overpowered’ study dshah 2022-06-16 10:43

‘Two-at-a-Time’ approach with >3 treatments Helmut 2022-06-12 11:37 [Design Issues]
- ‘Two-at-a-Time’ approach with >3 treatments Shuanghe 2022-06-12 19:02
  - ‘Two-at-a-Time’ approach with >3 treatments Helmut 2022-06-12 20:10

bear package 2.90 in R: data export mercury606 2022-06-10 13:25 [🇷 for BE/BA]

Publication of the final ICH M10 guideline Ohlbe 2022-06-10 10:48 [BE/BA News]
- Publication of the final ICH M10 guideline qualityassurance 2022-06-12 12:31
  - Chromatograms Ohlbe 2022-06-14 11:37

Center term in Bioequivalence Study balakotu 2022-06-08 08:03 [Study Assessment]
- Few subjects and many centers… Helmut 2022-06-08 11:56
- Center term in Bioequivalence Study ElMaestro 2022-06-08 13:14

Non-parametric statistical analysis methodology of tmax Imph 2022-06-07 16:56 [Nonparametrics]
- Acceptance limits for tmax Helmut 2022-06-07 17:32
  - Acceptance limits for tmax Imph 2022-06-13 10:30

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