Bioequivalence and Bioavailability Forum

Regarding used normal Two-way crossover program was used for un-scaled average Sivakrishna 2020-06-01 11:47
- (2×2×2?) ANOVA instead of mixed model Helmut 2020-06-01 15:08

Outlier in BE study Amira Gouda 2020-04-28 15:36
- Outlier in BE study mittyri 2020-04-29 11:50
- Outlier in BE study Ohlbe 2020-04-29 15:19
  - Outlier in BE study Amira Gouda 2020-04-29 16:35
    - Missing samples Ohlbe 2020-04-29 17:02
      - Missing samples Amira Gouda 2020-04-29 17:08
        
        Missing samples ElMaestro 2020-04-29 17:21
        
        Missing samples Amira Gouda 2020-05-01 23:50
        
        Options Helmut 2020-05-02 11:35
        
        Options Amira Gouda 2020-05-03 21:15

Meets primary objective but not secondary objective Brus 2020-03-27 17:22
- Meets primary objective but not secondary objective kratos 2020-03-31 03:17
- Meets primary objective but not secondary objective Achievwin 2020-03-31 21:09
  - Meets primary objective but not secondary objective kratos 2020-04-01 02:00
    - Meets primary objective but not secondary objective Achievwin 2020-04-06 19:41

The same PI for two studies in the same time wienui 2020-01-05 18:22
- The same PI for two studies in the same time ElMaestro 2020-01-05 21:38
  - The same PI for two studies in the same time wienui 2020-01-06 04:05
    - The same PI for two studies in the same time Ohlbe 2020-01-06 12:27
      - The same PI for two studies in the same time Helmut 2020-01-06 13:34
- The same PI for two studies in the same time jag009 2020-01-28 20:16

BEQ inquiry from health authority Aymanmy 2019-12-18 08:51
- BEQ inquiry from health authority Dr_Dan 2019-12-18 14:46
- Method not sensitive enough Helmut 2019-12-18 15:16
  - Revalidation? mittyri 2019-12-18 16:52
    - Revalidation? Helmut 2019-12-18 17:40
  - Method not sensitive enough Aymanmy 2019-12-18 17:58
    - Method not sensitive enough Helmut 2019-12-18 18:54
      - Method not sensitive enough Aymanmy 2019-12-19 08:21

Impact of Parenteral hydration in a BE study Cec75 2019-11-15 16:39
- Violation of GCP‽ Helmut 2019-11-15 17:48
- Impact of Parenteral hydration in a BE study ElMaestro 2019-11-15 21:51
  - Impact of Parenteral hydration in a BE study Cec75 2019-11-19 16:03

NTI drug Bioequivalence study Statistical approach Sukalpa Biswas 2019-08-06 09:15
- Cherry-picking? Helmut 2019-08-07 11:09
  - digging out the possible reasons of the failure Sukalpa Biswas 2019-08-09 06:11
    - Fed state: T higher variable than R Helmut 2019-08-09 12:36

Call me stupid if you think so... jag009 2019-07-27 04:43
- Call me stupid if you think so... ElMaestro 2019-07-27 09:26
  - Call me stupid if you think so... jag009 2019-07-28 20:04
    - Call me stupid if you think so... nobody 2019-07-28 21:58

Good News, Bad News Datacollector 2019-07-27 12:09
- Good News only Helmut 2019-07-27 13:15
  - Good News only, but not according to some Datacollector 2019-07-27 13:34
    - ’Some’ should read the GL (and again, and again) Helmut 2019-07-27 13:48
    - Good News only, but not according to some ElMaestro 2019-07-27 13:50
      - My stuff Helmut 2019-07-27 16:55
        
        My stuff ElMaestro 2019-07-27 17:38
        
        My stuff Datacollector 2019-07-27 19:13
        
        ≡ Helmut 2019-07-27 23:53
        
        Sequence effect Vs Subject effect? mittyri 2019-07-28 15:19
        
        Sequence effect Vs Subject effect? Helmut 2019-07-28 15:59
        
        Sequence effect Vs Subject effect? mittyri 2019-07-28 16:20
        
        Oops! Helmut 2019-07-28 16:36

In-vitro microbial kill rate study kumarnaidu 2019-04-26 10:31
- In-vitro microbial kill rate study ElMaestro 2019-04-26 11:07

SAS code for the mixed effects model with sequence mistakenly assigned libaiyi 2019-04-19 09:32
- Failure in randomization Helmut 2019-04-19 12:07
  - Real sensitivity mittyri 2019-04-19 16:19
- What is your root cause? ElMaestro 2019-04-19 15:14

Clinical end point acceptance limit PKS 2019-04-05 08:45
- Clinical end point acceptance limit ElMaestro 2019-04-05 08:51
  - Clinical end point acceptance limit nobody 2019-04-05 09:04
  - Clinical end point acceptance limit PKS 2019-04-05 09:17
    - –0.2025 < –0.2, right? Helmut 2019-04-05 10:53

Carry-over in pre-dose samples for steady state BE hirenpharm 2019-03-29 20:56
- Carry-over in pre-dose samples for steady state BE Nirali 2019-03-30 07:20
- 5% Cmax-rule only in SD Helmut 2019-03-31 14:52
  - 5% Cmax-rule only in SD Nirali 2019-04-03 02:48
- Carry-over in pre-dose samples for steady state BE jag009 2019-04-02 17:46

BE assessment regarding first time point Cmax Mann 2018-12-09 10:14
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
  - BE assessment regarding first time point Cmax Mann 2018-12-10 00:28
    - BE assessment regarding first time point Cmax Ohlbe 2018-12-11 00:05
    - FDA and outliers mittyri 2018-12-11 16:38
    - BE assessment regarding first time point Cmax Erkin 2018-12-28 08:29
      - BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
        
        BE assessment regarding first time point Cmax Erkin 2018-12-28 20:57
        
        regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
        
        Good question, next question Helmut 2019-03-03 19:42
        
        first point Cmax: trouble waiting to happen? Astea 2019-03-03 21:42

Thalidomide Rosy 2019-02-19 23:09
- Thalidomide jag009 2019-02-26 16:07

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