Bioequivalence and Bioavailability Forum

EMA: New product-specific guidances Helmut 2022-04-08 15:17 [BE/BA News]
- How would you implement it? ElMaestro 2022-04-09 11:45
  - Confuse a Cat Inc. Helmut 2022-04-09 18:40
    - Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
      - Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
        
        Confuse a Cat Inc. Helmut 2022-04-11 13:59
        
        Range Ohlbe 2022-04-11 15:48
        
        Range Helmut 2022-04-11 16:07
        
        Range Ohlbe 2022-04-11 16:20
        
        Range Helmut 2022-07-28 14:43
      - So many questions, so few answers Helmut 2022-04-11 13:03
      - Preliminary simulations Helmut 2022-04-30 14:59
        
        Preliminary simulations ElMaestro 2022-04-30 19:10
        
        Preliminary simulations Helmut 2022-05-01 15:56
        Revisions of the PSGLs final Helmut 2023-06-23 13:29
        
        Revisions of the PSGLs final dshah 2023-06-28 14:43
        
        EMA: No problems with many sampling time points… Helmut 2023-06-28 15:59
        New simulations & some desultory thoughts Helmut 2023-06-29 11:34
        
        SCNR. A heretic alternative. Helmut 2023-06-30 11:50
      - Simulated distributions Helmut 2022-05-02 13:43

concentration-time profile with two peaks or more Imph 2023-06-27 13:06 [NCA / SHAM]
- concentration-time profile with two peaks or more dshah 2023-06-27 13:13
  - concentration-time profile with two peaks or more Imph 2023-06-27 13:26
    - What does ‘max’ in Cmax mean? Helmut 2023-06-27 13:44
      - What does ‘max’ in Cmax mean? Imph 2023-06-27 15:18
        
        Which software? Helmut 2023-06-27 15:24
        
        Which software? Imph 2023-06-27 16:56
        
        tmax ≠ Cmax 🙂 Helmut 2023-06-27 17:03
        
        tmax ≠ Cmax 🙂 Imph 2023-06-27 17:33
        
        tmax ≠ Cmax 🙂 BEQool 2023-06-27 18:25

Validation of PhEq_bootstrap Helmut 2018-07-12 17:47 [Software]
- Validation of PhEq_bootstrap ElMaestro 2018-07-12 22:21
  - Validation of PhEq_bootstrap Helmut 2018-07-13 01:29
    - Validation of PhEq_bootstrap ElMaestro 2018-07-13 10:14
      - Validation of PhEq_bootstrap Helmut 2018-07-13 12:54
        
        Validation of PhEq_bootstrap ElMaestro 2018-07-13 14:28
- Validation of PhEq_bootstrap Shuanghe 2018-07-17 15:54
- PhEq_bootstrap in R d_labes 2018-08-15 09:45
  - bootf2BCA v1.1 Helmut 2019-10-05 00:59
    - bootf2BCA v1.2: seed Helmut 2020-09-25 19:37
      - bootf2BCA v1.2: seed PTM139 2021-04-16 07:53
        
        Which packages, working directory? Helmut 2021-04-16 10:50
        
        Which packages, working directory? PTM139 2021-04-27 13:02
      - bootf2BCA v1.2: seed Rayhope 2022-03-28 14:35
        
        bootf2BCA v1.3 Helmut 2022-03-28 14:48
        
        bootf2BCA v1.3 Rayhope 2022-03-30 06:34
    - bootf2BCA v1.1 Flam 2023-06-21 03:41
      - bootf2BCA v1.3.1 (current since 2022-06-25) Helmut 2023-06-23 13:47
        
        bootf2BCA v1.3.1 (current since 2022-06-25) Flam 2023-06-26 23:16
        
        Install required packages first Helmut 2023-06-27 11:47
- Validation of PhEq_bootstrap Rayhope 2021-07-29 08:49
  - Validation of PhEq_bootstrap Helmut 2021-08-02 18:12

Outlier NK 2023-06-27 03:57 [Study Assessment]
- Outlier dshah 2023-06-27 08:42
- Visual inspection of the fit! Helmut 2023-06-27 09:56

bear installation problem Imph 2023-06-20 12:25 [🇷 for BE/BA]
- bear 2.9.1 on 🇷 4.3.1 Helmut 2023-06-20 14:14
  - bear 2.9.1 on 🇷 4.3.1 Imph 2023-06-22 09:02

SD crossover study with no washout any examples Achievwin 2023-06-19 16:37 [Design Issues]
- 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

Calculation of PE and 90% CI Brus 2023-06-14 16:34 [General Statistics]
- No ‘R1’ and ‘R2’ in replicate designs Helmut 2023-06-14 22:26
  - No ‘R1’ and ‘R2’ in replicate designs Brus 2023-06-15 14:07
    - Rose is a rose is a rose is a rose Helmut 2023-06-15 14:49
    - No ‘R1’ and ‘R2’ in replicate designs Achievwin 2023-06-19 19:42

Isotretinoin Capsules 40 mg fed studies Venkata Chaitanya Reddi 2023-06-14 10:19 [Study Assessment]
- Isotretinoin Capsules 40 mg fed studies dshah 2023-06-15 08:29
  - Isotretinoin Capsules 40 mg fed studies Venkata Chaitanya Reddi 2023-06-16 04:21
    - Isotretinoin Capsules 40 mg fed studies dshah 2023-06-16 08:27
      - Isotretinoin Capsules 40 mg fed studies Venkata Chaitanya Reddi 2023-06-16 08:48

Including duplicates of Low, medium and High QCs during analytical method validation Ayman Rabayah 2023-06-15 07:14 [Regulatives / Guidelines]
- Including duplicates of Low, medium and High QCs during analytical method validation dshah 2023-06-15 08:36

Method for replicate design d_labes 2008-01-23 16:00 [Nonparametrics]
- Method for replicate design Helmut 2008-01-23 16:50
  - Method for replicate design d_labes 2008-01-24 08:36
    - Method for replicate design Helmut 2008-01-24 12:13
  - Method for replicate design kimhuang 2023-06-14 10:43

within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-08 13:54 [General Statistics]
- within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-08 16:35
  - within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-09 07:15
    - within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-14 09:26
      - within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-14 09:33
        
        within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-14 10:37

Linagliptin/Metformin Hydrochloride film-coated tablets Venkata Chaitanya Reddi 2023-06-09 07:18 [Study Assessment]
- Linagliptin/Metformin Hydrochloride film-coated tablets dshah 2023-06-09 11:51
  - Linagliptin/Metformin Hydrochloride film-coated tablets Venkata Chaitanya Reddi 2023-06-09 12:01

Switchability with replicate design studies Achievwin 2022-05-20 04:44 [Design Issues]
- 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

Reference-Scaled Average Bioequivalence Brus 2023-06-06 12:18 [RSABE / ABEL]
- FDA: TRT|RTR instead of TRR|RTR|RRT? Helmut 2023-06-07 10:22

Sample size estimation for parallel design with more than 2 treatments BEQool 2023-05-24 21:05 [Power / Sample Size]
- Sample size estimation for parallel design with more than 2 treatments dshah 2023-05-25 09:42
- >2 treatments, multiplicity or not Helmut 2023-05-27 08:26
  - >2 treatments, multiplicity or not BEQool 2023-05-29 10:41

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