Bioequivalence and Bioavailability Forum

Torasemide BE Study EU pmohite 2020-06-22 11:25

Two-stage BE study Achievwin 2020-06-17 15:12
- Two-stage BE study jag009 2020-06-18 07:06

How to analyze bioavailable of single arm data comparing a historical control libaiyi 2020-06-09 07:48
- Dazed and confused Helmut 2020-06-09 16:57
- Bridging study? d_labes 2020-06-11 18:27

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

Randomization for Replicate design studies mmw 2020-04-18 13:43
- Randomization for Replicate design studies Helmut 2020-04-20 12:18
  - Randomization for Replicate design studies mmw 2020-04-28 09:27

long acting Injection pankajsojitra 2020-04-19 11:15
- long acting Injection jag009 2020-04-21 21:06
  - long acting Injection pankajsojitra 2020-04-23 14:40

Steady State Bioequivalence Study Pharma_88 2020-01-08 10:07
- Pre-dose samples Helmut 2020-01-09 12:36
  - Study design multiple dose stuy - circadian PK Summertime 2020-03-26 17:29

NTI drugs and Full Replicate Pharma_88 2020-03-10 06:39
- FDA: 2×2×4 design; RSABE + ABE + σwT/σwR Helmut 2020-03-10 13:54
  - FDA: 2×2×4 design; RSABE + ABE + σwT/σwR Pharma_88 2020-03-13 09:14
    - FDA: NTID and “HVNTID” Helmut 2020-03-13 10:35

Fast & fed studies Amira Gouda 2020-03-01 20:28
- Fast & fed studies alghazam 2020-03-03 10:24
- Fast & fed studies Ohlbe 2020-03-03 11:58
  - Fast & fed in one study (alternative) Helmut 2020-03-04 14:15
    - Fast & fed in one study (alternative) Shuanghe 2020-03-04 16:13
      - Fast & fed in one study (alternative) jag009 2020-03-04 19:25
      - Fast & fed in one study (alternative) Helmut 2020-03-05 11:50
        
        Fast & fed in one study (alternative) Shuanghe 2020-03-05 16:02
        
        Fast & fed in one study (alternative) Marcelo Davanco 2020-03-06 13:35

Study which captures SD and SS PK Profiles jag009 2020-02-03 20:15
- A vs B mittyri 2020-02-03 21:05
  - A vs B jag009 2020-02-03 21:29
- ANDA or NDA? Helmut 2020-02-04 00:57
  - Modelling mittyri 2020-02-04 09:02
    - Modelling Helmut 2020-02-04 12:17
      - Modelling: SD+SS mittyri 2020-02-04 12:38

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