Bioequivalence and Bioavailability Forum

Significant difference in Cmax of Reference drug product Mehul Patel 2021-08-17 10:00
- Significant difference in Cmax of Reference drug product Helmut 2021-08-17 11:57
  - Significant difference in Cmax of Reference drug product Mehul Patel 2021-08-17 12:02
    - Different products → different BA Helmut 2021-08-17 15:36
    - Significant difference in Cmax of Reference drug product dshah 2021-08-21 10:48
      - Reasons? Helmut 2021-08-21 21:43
        
        Reasons? dshah 2021-08-24 12:06

Confidence interval between two study for same test and reference lot RahulG628 2021-08-04 17:40
- Different PE in repeated study Helmut 2021-08-04 21:03
- Confidence interval between two study for same test and reference lot ElMaestro 2021-08-04 21:41

Fully Replicate Study NK 2021-04-26 09:46
- Outliers in study intended for RSABE Helmut 2021-04-26 12:24
  - Outliers in study intended for RSABE Ohlbe 2021-04-26 18:30
    - failed study? mittyri 2021-04-26 19:01
      - Failed study Helmut 2021-04-27 00:33
    - Failed study Helmut 2021-04-27 00:28

Bioequivalence study of Glimepride Tablet Ibrahim Komeil 2021-02-15 10:07
- Reformulate… Helmut 2021-02-15 10:59
  - Reformulate… Ibrahim Komeil 2021-02-15 23:48

Deficiencies ?? Helmut 2021-01-26 10:47
- Deficiencies ?? ElMaestro 2021-01-26 12:26
  - Deficiencies ?? Helmut 2021-01-26 18:52
    - Deficiencies ?? ElMaestro 2021-01-26 22:34
- Deficiencies or not zizou 2021-01-31 01:07
  - Deficiencies or not Helmut 2021-01-31 15:46

Data manipulation / fraud in BE ElMaestro 2020-10-21 09:56

Subject non compliance Loky do 2020-07-15 12:57
- Subject non compliance (or product failure?) Helmut 2020-07-16 14:30
  - Subject non compliance (or product failure?) Loky do 2020-07-16 22:29
    - Bad science (statistics is taboo) Helmut 2020-07-17 01:01
      - unexpected behavior for test product Loky do 2020-07-22 11:29
        
        Subject-by-Formulation interaction? Helmut 2020-07-22 12:03
        
        Subject-by-Formulation interaction? Loky do 2020-07-26 11:30

Missing concentration shahajan baig 2020-07-06 01:15
- Missing concentration Sukalpa Biswas 2020-07-13 13:51

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

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