Bioequivalence and Bioavailability Forum

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

Two Stage Desing: ANOVA earlybird 2009-10-16 11:25 [Two-Stage / GS Designs]
- Potvin et al: effects in stage 2 Helmut 2009-10-16 13:32
  - Potvin et al: effects in stage 2 d_stat 2021-07-19 16:26
    - Forget simulation-based TSDs for 2×2×2 in Europe Helmut 2021-07-19 17:22
      - TSD statistical model - with multiple sites d_stat 2021-07-20 13:58
        
        TSD statistical model - with multiple sites Helmut 2021-07-20 21:52

HVD Pilot: 3 candidates, 1 reference Shah 2021-07-16 13:40 [Design Issues]
- HVD Pilot: 3 candidates, 1 reference ElMaestro 2021-07-16 13:51
  - HVD Pilot: 3 candidates, 1 reference lukamar 2021-07-20 08:54
    - HVD Pilot: 3 candidates, 1 reference ElMaestro 2021-07-20 09:31

randomizeBE - randomness control d_labes 2012-07-10 13:02 [R for BE/BA]
- randomizeBE - randomness control Helmut 2012-07-10 14:20
  - runs test - critical values d_labes 2012-07-10 16:58
  - randomizeBE - randomness control d_labes 2012-07-12 10:34
    - randomness control Helmut 2021-07-15 16:07
      - randomness control Ohlbe 2021-07-15 17:59
        
        randomness control Helmut 2021-07-15 18:32
      - randomness control d_labes 2021-07-18 11:15

statistical approaches for dose-finding PK studies Sridhar.E 2021-07-13 11:04 [Regulatives / Guidelines]
- statistical approaches for dose-finding PK studies msmnainar 2021-07-17 19:04

BE for a drug dosed on body weight Achievwin 2021-07-06 14:37 [Study Performance]
- BE for a drug dosed on body weight dshah 2021-07-17 11:46

Bracketing approach for multiple strenght product EMA jag009 2021-07-06 19:19 [Regulatives / Guidelines]
- Bracketing approach for multiple strenght product EMA dshah 2021-07-17 11:44

Results Analysis unique_one 2014-07-08 08:58 [Study Assessment]
- Results Analysis ElMaestro 2014-07-08 10:08
  - Results Analysis unique_one 2014-07-08 10:42
    - Don’t hurry; explore consequences Helmut 2014-07-08 12:00
      - Don’t hurry; explore consequences unique_one 2014-07-08 14:01
        
        The smaller a study, the more uncertain its results Helmut 2014-07-08 17:39
        
        The smaller a study, the more uncertain its results unique_one 2014-07-09 06:59
        
        The smaller a study, the more uncertain its results unique_one 2014-07-10 07:09
    - 156 ? d_labes 2014-07-08 12:03
      - 156 ? unique_one 2014-07-08 14:03
    - Results Analysis Shuanghe 2014-07-08 12:57
      - Results Analysis unique_one 2014-07-08 14:08
        
        Results Analysis Samaya B 2014-07-09 07:58
        
        bootstrap Shuanghe 2014-07-09 18:26
        
        bootstrap Weidson 2021-07-03 01:36
        
        Bootstrapping BE: An attempt in 🇷 Helmut 2021-07-08 13:50
        
        Bootstrapping BE: An attempt in 🇷 ElMaestro 2021-07-09 14:15
        
        Bootstrapping BE: Desultory thoughts Helmut 2021-07-09 14:50
        
        Bootstrapping BE: Desultory thoughts ElMaestro 2021-07-09 16:29
        
        Bootstrapping BE: Desultory thoughts Helmut 2021-07-09 21:04

Ethnicity of Indian population Vishal S 2021-06-22 07:25 [Regulatives / Guidelines]
- Ethnicity of Indian population drgunasakaran1 2021-06-24 06:06
  - Ethnicity of Indian population VijithRoy 2021-06-30 06:43
- Ethnicity of Indian population Achievwin 2021-07-06 16:21

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

CDCA / Chenodeoxycholic acid / Chenodiol CV% Mohamed Yehia 2021-07-05 11:11 [Power / Sample Size]

End study requirements for Brazil submission khageswara Rao 2021-07-01 08:43 [Regulatives / Guidelines]
- End study requirements for Brazil submission drgunasakaran1 2021-07-05 10:15

Intrauterine Device – Levonorgestrel 52 mg marianna.macera 2021-06-30 15:04 [Design Issues]
- Intrauterine Device – Levonorgestrel 52 mg Relaxation 2021-06-30 17:22
  - Intrauterine Device – Levonorgestrel 52 mg marianna.macera 2021-07-02 16:55
    - Intrauterine Device – Levonorgestrel 52 mg Helmut 2021-07-02 17:18

WHO: scaling for AUC? Ohlbe 2017-06-12 13:29 [BE/BA News]
- WHO: Chapeau! Helmut 2017-06-12 23:31
  - WHO: Chapeau! ElMaestro 2017-06-13 00:08
    - WHO: Chapeau! nobody 2017-06-13 09:28
    - WHO: Chapeau! Helmut 2019-06-10 11:23
      - WHO: Chapeau! ElMaestro 2019-06-11 18:51
- WHO: scaling for AUC confirmed Ohlbe 2021-07-02 10:31
  - No comparison of variabilities any more 😀 Helmut 2021-07-02 15:11

Calculation of % Liver FPE pharm07 2021-06-30 05:33 [PK / PD]
- PBPK Helmut 2021-06-30 10:27
  - PBPK pharm07 2021-07-01 16:59
    - PBPK Helmut 2021-07-01 17:09

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