Bioequivalence and Bioavailability Forum

Regulatory Query for study repeat sam 2013-07-27 07:50
- Repeats ElMaestro 2013-07-27 11:01
  - Repeats sam 2013-07-27 11:18
    - Repeats ElMaestro 2013-07-27 11:31
      - Repeats sam 2013-07-27 11:57
        
        Repeats ElMaestro 2013-07-27 12:27
        
        Repeats sam 2013-07-27 12:45
        
        Bad science Helmut 2013-07-27 14:15
        
        Bad science sam 2013-07-28 09:05
        
        Posting style & incomplete information Helmut 2013-07-28 12:32
        
        Posting style & incomplete information sam 2013-07-29 06:46
        
        RTFM! Helmut 2013-07-29 07:53
        
        RTFM! sam 2013-07-29 08:40
        
        copy & paste error or what? Helmut 2013-07-29 11:14
        
        copy & paste error or what? sam 2013-07-29 12:46
        
        Calm down! jag009 2013-07-29 16:06
        
        Slightly off-topic: The wonders of pilot trials ElMaestro 2013-07-29 09:19
        
        Futility rule? Helmut 2013-07-29 12:16
        
        Futility rule? ElMaestro 2013-07-29 12:46
        
        Slightly off-topic: The wonders of pilot trials sam 2013-07-29 12:41
        
        PE of AUC? Helmut 2013-07-29 12:45
        
        PE of AUC? sam 2013-07-29 12:56
        
        EOD Helmut 2013-07-29 13:18
        
        Posting style & incomplete information jag009 2013-07-29 16:32
        
        Posting style & incomplete information sam 2013-07-30 06:08
        
        Bad science ElMaestro 2013-07-28 12:43
      - Repeats jag009 2013-07-27 22:17
        
        Repeats ElMaestro 2013-07-27 23:11
- Regulatory Query for study repeat jag009 2013-07-27 22:29
  - Regulatory Query for study repeat sam 2013-07-29 12:36
    - Regulatory Query for study repeat luvblooms 2013-07-30 08:28
      - More questions.. jag009 2013-07-30 16:53

Add more subjects after a failed BE study of a HVD wxp 2013-05-27 10:34
- bad luck Dr_Dan 2013-05-27 12:28
  - bad luck wxp 2013-05-27 14:19
- Beware of Add-on Studies! Helmut 2013-05-27 13:51
  - Beware of Add-on Studies! Shuanghe 2013-05-27 15:59
    - Oh wow! Helmut 2013-05-27 16:21
      - The same criterion of Cmax in China now wxp 2013-05-28 06:10
        
        SFDA ⇒ CFDA Helmut 2013-05-28 13:02
        
        Helmut, updated Chinese BE guideline here Shuanghe 2013-06-14 11:05
        
        BE in Chinese Pharmacopoeia Helmut 2013-06-14 14:22
        
        BE in Chinese Pharmacopoeia Shuanghe 2013-06-14 14:56
        
        BE in Chinese Pharmacopoeia Helmut 2013-06-14 16:11
  - Add more subjects after a failed BE study of a HVD wxp 2013-05-28 05:13
    - Still many subjects… Helmut 2013-05-28 12:56

Interesting Data from HVD study jag009 2013-05-16 22:15
- Detlew? Helmut 2013-05-17 02:03
  - What is the question? d_labes 2013-05-20 17:28
    - Answer: forget the partial replicate! Helmut 2013-05-20 18:17
    - What is the question? jag009 2013-06-04 16:04

Question about subject with very few timepoints jag009 2013-04-25 17:45
- Reliable profile Helmut 2013-04-25 18:16
  - Reliable profile jag009 2013-04-25 20:19
    - Reliable profile ElMaestro 2013-04-25 22:40
      - CVintra result of outlier Dr_Dan 2013-04-26 08:58

First point Cmax Smitha 2012-12-04 09:36
- First point Cmax Dr_Dan 2012-12-04 10:35
  - First point Cmax Smitha 2012-12-08 06:24
    - Search, search ... d_labes 2012-12-09 19:16

Deviation in predose fasting duration of 10 hours scorp2011 2012-10-30 10:14
- Deviation in predose fasting duration of 10 hours drgunasakaran1 2012-11-01 10:11

Failure of BE in fasting studies ABE1580 2012-10-09 15:42
- Failure of BE in fasting studies drgunasakaran1 2012-10-09 20:07
  - Failure of BE in fasting studies cakhatri 2012-10-10 07:34
    - Failure of BE in fasting studies Dr_Dan 2012-10-10 13:09
    - Different designs: why not? Helmut 2012-10-10 13:48
      - Different designs: why not? cakhatri 2012-10-12 10:42
    - Failure of BE in fasting studies drgunasakaran1 2012-10-10 19:14
      - Failure of BE in fasting studies ABE1580 2012-10-11 06:10
  - Failure of BE in fasting studies drsinghs 2012-10-11 09:28
    - Failure of BE in fasting studies Dr_Dan 2012-10-11 11:43
      - 1–β not necessarily = Δ Helmut 2012-10-11 13:05
      - Sample size d_labes 2012-10-11 13:10
        
        +partial replicate Helmut 2012-10-11 17:53

high concentration in the elimination phase-Metaxalone cakhatri 2012-09-07 05:58
- high concentration in the elimination phase-Metaxalone jag009 2012-09-07 23:20
  - high concentration in the elimination phase-Metaxalone cakhatri 2012-09-08 06:08
    - Enterohepatic recirculation Helmut 2012-09-08 12:29
      - Enterohepatic recirculation cakhatri 2012-09-11 06:26
        
        Enterohepatic recirculation jag009 2012-09-13 19:56
    - high concentration in the elimination phase-Metaxalone jag009 2012-09-10 22:30
      - high concentration in the elimination phase-Metaxalone cakhatri 2012-09-11 06:29
        
        high concentration in the elimination phase-Metaxalone Chiku 2012-09-14 06:30

First point Cmax auditor 2012-02-10 06:50
- First point Cmax drgunasakaran1 2012-02-10 07:00
  - First point Cmax rana 2012-08-18 06:48
    - First point Cmax drgunasakaran1 2012-08-21 07:01
- First point Cmax lukamar 2012-09-10 13:54

To calculate AUC0-inf in Scaled average bioequivalence aquapurple 2012-08-24 11:50
- Completely lost sequence in partial replicate Helmut 2012-08-24 20:07

Statistical Out come auditor 2012-02-01 12:58
- Statistical Out come ElMaestro 2012-02-02 12:05
- Statistical Out come Ohlbe 2012-02-02 19:13

Predose concentration more than 5 % of Cmax kamblpa1 2011-12-27 05:19
- Exclusion of subjects (predose >5 % of Cmax) Helmut 2011-12-27 18:35

pre-dose concentrations above LLOQ Paola 2011-12-21 12:58
- pre-dose concentrations above LLOQ ElMaestro 2011-12-21 14:34
  - pre-dose concentrations above LLOQ Paola 2011-12-22 16:58
    - pre-dose concentrations above LLOQ Ohlbe 2011-12-22 22:06
- pre-dose concentrations above LLOQ Helmut 2011-12-21 15:30
  - pre-dose concentrations above LLOQ Paola 2011-12-22 17:16

Pre Treatment drug levels JOI 2011-11-16 11:57
- Pre Treatment drug levels Helmut 2011-11-16 13:59
  - Pre Treatment drug levels JOI 2011-11-16 17:11
    - Protocol Deviation Helmut 2011-11-16 18:11

Redosing study… H.Patel 2011-06-15 16:28
- Redosing study… swapnil.kuche 2011-06-16 08:35
  - Redosing study… Dr_Dan 2011-06-16 12:37
    - Redosing study… Helmut 2011-06-16 12:52
    - Redosing study… GSTATS 2011-06-16 16:12
    - Redosing study… luvblooms 2011-06-17 06:34
      - Redosing study… ElMaestro 2011-06-17 09:16
        
        Redosing study… luvblooms 2011-06-17 12:50
        
        Redosing study… ElMaestro 2011-06-17 13:09
        
        Redosing study… luvblooms 2011-06-18 11:47
        
        Redosing study… GSTATS 2011-06-17 16:57
        
        Redosing study… luvblooms 2011-06-18 11:53