Bioequivalence and Bioavailability Forum

Steady State Bioequivalence Study Pharma_88 2020-01-08 10:07
- Pre-dose samples Helmut 2020-01-09 12:36

3+3 Design Pharma_88 2020-01-07 08:09
- 3+3 Design Ohlbe 2020-01-07 11:25
  - 3+3 Design Pharma_88 2020-01-08 09:55
    - Subject replacement Ohlbe 2020-01-08 10:41
- Dose escalation and DMC Helmut 2020-01-07 12:18
  - Dose escalation and DMC Pharma_88 2020-01-08 09:56

Normal Reference Range Vs Pre-defined site normal values cakhatri 2019-12-17 11:35
- Normal Reference Range Vs Pre-defined site normal values ElMaestro 2019-12-17 23:21
- Hb level Ohlbe 2019-12-29 17:04
  - OT Helmut 2019-12-29 18:49
  - Hb level nobody 2019-12-31 10:47
  - Hb level ElMaestro 2019-12-31 15:19
    - Hb level nobody 2019-12-31 15:46
      - Hb level ElMaestro 2019-12-31 17:21
        
        Hb level nobody 2019-12-31 17:26
        Participation databases Helmut 2019-12-31 18:01
        
        Participation databases ElMaestro 2019-12-31 20:21
        
        Participation databases Helmut 2020-01-01 10:23
        
        Participation databases ElMaestro 2020-01-01 12:23
        
        Participation databases nobody 2020-01-02 10:35
        Participation databases Ohlbe 2020-01-02 12:18
        
        National databases‽ Helmut 2020-01-02 13:06
        
        Great discussion ElMaestro 2020-01-02 16:31
        
        Great discussion Ohlbe 2020-01-02 16:57
        
        Great discussion ElMaestro 2020-01-02 18:19
        
        WTF 😡 Helmut 2020-01-02 18:42
        
        Great discussion Helmut 2020-01-02 17:14
        
        National databases‽ Ohlbe 2020-01-02 16:36

Should those subjects have only one period data be included in BE analysis? ssussu 2019-12-06 10:58
- No way! But... Beholder 2019-12-06 12:36
  - No way! But... ElMaestro 2019-12-06 13:14
    - No way! But... Helmut 2019-12-06 14:47
      - No way! But... PharmCat 2019-12-06 23:46
        
        No way! But... wienui 2019-12-07 04:01
        
        EMA guideline: no way...: mittyri 2019-12-07 20:58
        
        EMA guideline: no way...: wienui 2019-12-09 05:25
        
        Slightly off topic, but related :-) ElMaestro 2019-12-08 01:31
        
        Slightly off topic, but related :-) Shuanghe 2019-12-09 12:00
        Slightly off topic, but related :-) PharmCat 2019-12-09 15:13
        
        Slightly off topic, but related :-) ElMaestro 2019-12-21 15:02
        
        Slightly off topic, but related :-) PharmCat 2019-12-22 01:12
        2.220446e-16 ≈ 0 Helmut 2019-12-22 10:37
        
        The optional tolerance argument ElMaestro 2019-12-23 14:37
        2.220446e-16 ≈ 0 PharmCat 2019-12-24 14:18
        
        Sum of residuals ~ ε Helmut 2019-12-24 14:54
        
        Sum of residuals ~ ε ElMaestro 2019-12-24 15:10
        
        Wrong terminology Helmut 2019-12-28 13:55
        
        Sum of residuals ~ ε PharmCat 2019-12-24 18:40

BE study design issue jag009 2019-12-13 23:26
- 1×2 ≠ 2×1 Helmut 2019-12-14 00:42
  - 1×2 ≠ 2×1 jag009 2019-12-15 19:39
    - 1×2 ≠ 2×1 ElMaestro 2019-12-15 22:02
      - x ◦ y = y ◦ x? Helmut 2019-12-16 11:00
- BE study design issue Dr_Dan 2019-12-18 15:04
  - ER vs. IR Helmut 2019-12-18 15:33
    - ER vs. IR Dr_Dan 2019-12-19 09:01

Reference drugs for triple combination test drug in Russia Beholder 2019-11-13 12:47
- Reference drugs for triple combination test drug in Russia PharmCat 2019-11-13 21:25
  - Reference drugs for triple combination test drug in Russia Yura 2019-11-14 09:24
    - Reference drugs for triple combination test drug in Russia Beholder 2019-11-14 10:55
  - Reference drugs for triple combination test drug in Russia Beholder 2019-11-14 10:51
    - Reference drugs for triple combination test drug in Russia Mikalai 2019-11-15 13:36
      - OT: Speak with the regulator Helmut 2019-11-15 13:45
    - Reference drugs for triple combination test drug in Russia PharmCat 2019-11-15 20:07
      - Reference drugs for triple combination test drug in Russia mittyri 2019-11-15 23:29
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-16 17:22
      - Reference drugs for triple combination test drug in Russia Beholder 2019-11-18 10:13
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-18 22:47
        
        WHO FDC Scenario 2 mittyri 2019-11-19 09:25
        
        WHO FDC Scenario 2 PharmCat 2019-11-19 23:42
        
        EEU FDC Scenario 5.3.2 mittyri 2019-11-20 11:32
        
        EEU FDC Scenario 5.3.2 PharmCat 2019-11-20 15:39
        
        EMA example mittyri 2019-11-21 12:38
        
        Reference drugs for triple combination test drug in Russia Beholder 2019-11-19 14:39
        
        Reference drugs for triple combination test drug in Russia Yura 2019-11-19 21:51
        
        Reference drugs for triple combination test drug in Russia PharmCat 2019-11-21 14:02

Bicalutamide having Long Half Life udayk 2019-10-04 12:06
- Bicalutamide: Crossover not realistic Helmut 2019-10-07 14:59
  - Bicalutamide: Crossover not realistic udayk 2019-10-10 09:10

Two 2x2 and one 6x3 crossover design qzhou 2019-09-24 04:20
- Two 2x2 and one 6x3 crossover design Helmut 2019-09-24 10:57

Equivalency Studies for Injectables ilee9009 2019-09-20 10:24

suggest suitable Sequence for Reference replicate and Two Different Test? SP 2019-07-29 14:31
- Not sure whether it makes sense Helmut 2019-07-29 17:25
  - Not sure whether it makes sense abhimanyu 2019-08-03 13:54
    - Not sure whether it makes sense d_labes 2019-08-03 19:35
      - Not sure whether it makes sense abhimanyu 2019-08-05 09:27

Possible reasons for group effect GM 2019-07-20 07:36
- Group “effect” Helmut 2019-07-20 14:02
- Possible reasons for group effect ElMaestro 2019-07-20 19:20
  - Possible reasons for group effect GM 2019-07-23 06:23
    - “Group-by-Treatment Interaction” Helmut 2019-07-23 10:32

Steady State achievement rajasekharkakarla 2019-07-03 10:02

Bio Batch Size fedesalas 2018-09-12 17:46
- Bio Batch Size Ohlbe 2018-09-13 00:19
- Bio Batch Size Imadov 2019-05-11 11:43
  - Bio Batch Size wienui 2019-05-11 15:27

Three-way crossover BABE Studies acfalcao 2007-09-16 22:34
- Three-way crossover example data set Helmut 2007-09-17 20:47
  - Three-way crossover example data set acfalcao 2007-09-17 23:02
    - Three-way crossover example data set Helmut 2007-09-18 12:47
      - Three-way crossover (WinNonlin) Nirali 2007-09-21 06:49
        
        Three-way crossover (WinNonlin) Helmut 2007-09-21 13:04
        
        Three-way crossover (WinNonlin) Nirali 2007-09-25 08:05
        
        Three-way crossover (WinNonlin) Helmut 2007-09-25 13:15
      - Three-way crossover example data set Irene_I 2018-06-07 11:09
        
        Three-way crossover example data set Helmut 2018-06-07 13:04
        
        Three-way crossover example data set Irene_I 2018-06-08 11:09
        Three-way crossover example data set Irene_I 2018-06-12 09:21
        
        Leave-One-Out (IBD) Helmut 2018-06-12 12:42
        
        Leave-One-Out (IBD) Irene_I 2018-06-13 05:02
        
        Impact of pooled variance (bias, CI) Helmut 2018-06-13 15:02
        
        carry (over?) d_labes 2018-06-13 15:31
  - Pseudo-periods ElAlumno 2019-03-14 23:40
    - Pseudo-periods Helmut 2019-03-15 00:47
      - Two‐at‐a‐Time analysis in R ElAlumno 2019-03-22 21:59
        
        fixed & mixed (dammit!) and a request to SASians Helmut 2019-03-23 01:03
        
        Pooled vs IBD T-R in SAS from non-SASian mittyri 2019-03-23 23:13
        
        Pooled vs IBD T-R in SAS from non-SASian Helmut 2019-03-23 23:36
        
        mixed in R mittyri 2019-03-23 23:50
        
        mixed in R (EMA B ≠ FDA) Helmut 2019-03-24 01:23

Can we have two primary objectives? Achievwin 2019-01-24 17:50
- Can we have two primary objectives? ElMaestro 2019-01-25 09:55