Bioequivalence and Bioavailability Forum

Amlodipine/Valsartan Bebac user 2023-09-09 06:34
- 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
- Ebastine study design dshah 2023-11-27 09:53

Adhesion Score Analysis durga09 2023-07-17 11:15

Stabilization period Vismayi 2023-06-26 19:55
- Stabilization period dshah 2023-06-27 08:46
- Stabilization period Achievwin 2023-06-30 15:13

SD crossover study with no washout any examples Achievwin 2023-06-19 16:37
- SD crossover study with no washout any examples wienui 2023-06-20 06:00
  - SD crossover study with no washout any examples Achievwin 2023-06-20 14:48

Switchability with replicate design studies Achievwin 2022-05-20 04:44
- Switchability = IBE Helmut 2022-05-20 09:17
  - Switchability = IBE Achievwin 2022-05-20 14:19
    - S × F interaction Helmut 2022-05-20 15:33
      - S × F interaction Achievwin 2022-05-20 23:32
      - S × F interaction Brus 2023-06-06 11:02
        
        S × F interaction Helmut 2023-06-07 10:34
        
        S × F interaction Achievwin 2023-06-08 10:21

Washout based on mean ± SD of t½ Imph 2022-09-25 13:52
- Washout based on mean ± SD of t½ Helmut 2022-09-25 16:08
  - Washout based on mean ± SD of t½ Imph 2022-09-26 15:24
    - Washout based on mean ± SD of t½ Shuanghe 2022-09-26 17:34
    - Washout based on mean ± SD of t½ Helmut 2022-09-26 17:35
    - If you have data… Helmut 2022-09-27 11:52
      - If you have data… Imph 2022-10-25 09:21
  - Washout based on mean ± SD of t½ Imph 2023-05-26 23:31
    - Washout based on mean ± SD of t½ Helmut 2023-05-27 06:52
      - Washout based on mean ± SD of t½ Imph 2023-05-27 08:36

Inclusion criteria in BE studies Loky do 2020-05-22 18:16
- BE: ♀♂ Helmut 2020-05-23 17:12
- Inclusion criteria in BE studies jag009 2020-05-25 07:43
  - Stratify for sex? Helmut 2020-05-25 12:48
    - Stratify for sex? jag009 2020-05-25 21:10
- Inclusion criteria in BE studies ElMaestro 2020-05-25 14:39
  - Inclusion criteria in BE studies Loky do 2020-06-10 13:19
  - Inclusion criteria in BE studies BEQool 2023-05-05 10:42
    - Sex-by-treatment interaction Helmut 2023-05-05 12:44
      - Sex-by-treatment interaction BEQool 2023-05-11 09:12

Definition of Full Replicate Sereng 2023-03-13 17:08
- Definition of Full Replicate Mahmoud 2023-03-13 20:27
  - Definition of Full Replicate Sereng 2023-03-13 23:38
    - Definition of Full Replicate Mahmoud 2023-03-14 08:44
      - Definition of Full Replicate Achievwin 2023-03-27 19:08
        
        Full Replicate with 3 periods mittyri 2023-03-27 22:16
        
        Full Replicate with 3 periods Achievwin 2023-03-28 03:06
        Full Replicate with 3 periods Helmut 2023-03-28 09:03
- Definition of Full Replicate Brus 2023-03-14 10:10
- Replicate Design ≠ Higher-Order Crossover Helmut 2023-03-14 10:37
  - Thank You! Sereng 2023-03-14 20:08
  - Replicate Design ≠ Higher-Order Crossover Relaxation 2023-03-20 08:56
    - imbalance in Latin Square mittyri 2023-03-27 23:01
    - Balance for all effects Helmut 2023-04-21 10:01

EU Transdermal Patch: Generic Submission HallaGulla 2023-03-08 08:58

Documentation of SS for LAI Achievwin 2023-02-06 13:40
- Documentation of SS for LAI dshah 2023-02-28 16:50

Study Design: Two treatment or Four treatment NK 2023-01-23 09:38
- Study Design: Two treatment or Four treatment dshah 2023-01-23 10:43
  - Study Design: Two treatment or Four treatment NK 2023-01-24 03:37
- Study Design: Two treatment or Four treatment ElMaestro 2023-01-23 15:05
  - Study Design: Two treatment or Four treatment Relaxation 2023-01-23 16:10

Initial dose and design issues abridged submission daily ER vs BID IR alejandro_jo1990 2022-09-15 15:35

Bioequivalence of mirabegron 50 mg extended release Tablet Ibrahim Komeil 2021-02-20 11:36
- Replicate designs based on information of 2×2×2 design Helmut 2021-02-20 14:50
  - Replicate designs based on information of 2×2×2 design Ibrahim Komeil 2021-02-20 18:34
    - Assumption of authority? Helmut 2021-02-20 20:50
- Bioequivalence of mirabegron 50 mg extended release Tablet jishnu 2022-08-04 09:09
- Bioequivalence of mirabegron 50 mg extended release Tablet qualityassurance 2022-08-04 15:47

Could we design the RCT as a non-inferiority trial at this situation? dennis001 2022-07-24 17:39
- Non-Superiority Helmut 2022-07-25 16:37
  - Non-Superiority dennis001 2022-07-26 02:32
    - Non-Superiority Helmut 2022-07-26 15:04
      - Non-Superiority dennis001 2022-07-27 05:18
        
        Placebo effect Helmut 2022-07-27 12:17
- Could we design the RCT as a non-inferiority trial at this situation? ElMaestro 2022-07-26 12:44
  - Could we design the RCT as a non-inferiority trial at this situation? dennis001 2022-07-27 05:21

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