Bioequivalence and Bioavailability Forum

BE assessment regarding first time point Cmax - Mann, 2018-12-09 10:14
- BE assessment regarding first time point Cmax - Ohlbe, 2018-12-09 23:46
  - BE assessment regarding first time point Cmax - Mann, 2018-12-10 00:28
    - BE assessment regarding first time point Cmax - Ohlbe, 2018-12-11 00:05
    - FDA and outliers - mittyri, 2018-12-11 16:38

subject withdrawn after bioanalysis - anbu, 2018-09-12 10:17
- Cherry-picking? - Helmut, 2018-09-12 12:34
  - Cherry-picking? - anbu, 2018-09-12 13:17

Cmax is out of the range - Mikalai, 2018-08-01 12:05
- Bad luck - Helmut, 2018-08-01 13:37
  - Bad luck - Mikalai, 2018-08-01 13:50
    - Cherry-picking - Helmut, 2018-08-01 15:01
- Cmax is out of the range - jag009, 2018-08-02 17:56

Definition of Enrolled subject - jag009, 2018-07-11 21:27
- Definition of Enrolled subject - Ohlbe, 2018-07-12 00:07
  - Definition of Enrolled subject - jag009, 2018-07-17 06:36

BE/BA centers - JLpiccard, 2018-07-13 20:35
- BE/BA centers - Helmut, 2018-07-13 22:42
  - BE/BA centers - JLpiccard, 2018-07-16 18:16
    - BE/BA centers - Helmut, 2018-07-16 18:51
- BE/BA centers - ElMaestro, 2018-07-13 22:42
  - BE/BA centers - JLpiccard, 2018-07-16 18:17

Marginally failed study for Europe - balakotu, 2018-04-24 07:30
- Marginally failed study for Europe - Yura, 2018-04-24 12:31
- Upper 90% CL 0.17% > U - Helmut, 2018-04-29 23:46

Outlier in BE - ramgopi, 2018-03-14 11:29
- Low AUC after reference product - Helmut, 2018-03-14 16:38
  - Low AUC after reference product - mittyri, 2018-03-15 10:56
- Outlier in BE - ramgopi, 2018-03-18 07:44
  - Outlier in BE - ElMaestro, 2018-03-18 14:43
    - Outlier in BE - ramgopi, 2018-03-19 10:55

When the the infusion speed deviate from the protocol specified - ssussu, 2018-02-06 10:48
- Different PK profile - Helmut, 2018-02-06 13:28
  - Different PK profile - ssussu, 2018-02-07 02:50
    - Different PK profile - Helmut, 2018-02-07 11:04
      - Different PK profile - ssussu, 2018-02-07 11:42
        
        Suitable equipment? - Helmut, 2018-02-07 14:13
        
        Suitable equipment? - ssussu, 2018-02-08 04:07
        
        AUC=f·D/CL - Helmut, 2018-02-08 10:28
        
        AUC=f·D/CL - ssussu, 2018-02-08 11:21
        
        AUC=f·D/CL - Helmut, 2018-02-08 21:55
        
        AUC=f·D/CL - ssussu, 2018-02-09 00:31
- When the the infusion speed deviate from the protocol specified - ElMaestro, 2018-02-07 13:20
  - When the the infusion speed deviate from the protocol specified - ssussu, 2018-02-08 04:23

CV values in BE studies: intra, or inter, or total? - Elena777, 2018-01-20 12:31
- CV values in BE studies: intra, or inter, or total? - jag009, 2018-01-20 19:18
  - CV values in BE studies: intra, or inter, or total? - Elena777, 2018-01-20 21:10
    - CV values in BE studies: intra, or inter, or total? - jag009, 2018-01-21 03:17
      - CV values in BE studies: intra, or inter, or total? - Elena777, 2018-01-21 08:21
- CV values in BE studies: intra, or inter, or total? - Helmut, 2018-01-21 17:33
- CV values in BE studies: intra, or inter, or total? - ElMaestro, 2018-01-21 18:17
  - CV values in BE studies: intra, or inter, or total? - Elena777, 2018-01-27 09:57
    - CV values in BE studies: intra, or inter, or total? - Louis52, 2018-02-07 20:22
      - CV values in BE studies: intra, or inter, or total? - Helmut, 2018-02-07 20:31

Ever handled the "wrong treatment" in a PK? - Relaxation, 2018-01-26 18:31

risk management - Norah, 2018-01-22 13:53

ULOQ - Anand, 2017-10-30 06:38
- ULOQ - Helmut, 2017-10-30 10:30
- ULOQ - Ohlbe, 2017-10-30 10:35
  - ULOQ - Helmut, 2017-10-30 10:59
    - ULOQ - Ohlbe, 2017-10-30 15:10
      - Not excluding invalid data? - Helmut, 2017-10-30 17:34
        
        Excluding invalid data - Ohlbe, 2017-10-30 18:03
- ULOQ - ElMaestro, 2017-10-30 13:18
  - Serial dilutions? Don’t! - Helmut, 2017-10-30 17:53

AUC infinity - mokhtar saleh, 2017-10-24 16:58
- AUC infinity: primary for the FDA - Helmut, 2017-10-24 17:14
  - AUC infinity: primary for the FDA - mokhtar saleh, 2017-10-24 18:29
    - AUC infinity: primary for the FDA - jag009, 2017-10-27 05:42

Atorvastatin intra-subject Variability - Amira, 2017-09-26 12:26
- Atorvastatin intra-subject Variability - ElMaestro, 2017-09-26 12:51
  - Atorvastatin intra-subject Variability - nobody, 2017-09-27 10:11
    - Atorvastatin intra-subject Variability - Helmut, 2017-09-27 11:05

EU ombudsman looking into EMA presubmission meetings - ElMaestro, 2017-07-19 20:24
- EU ombudsman looking into EMA presubmission meetings - Helmut, 2017-07-20 01:54
  - EU ombudsman looking into EMA presubmission meetings - ElMaestro, 2017-07-20 10:09
- EU ombudsman looking into EMA presubmission meetings - Ohlbe, 2017-07-20 10:12

Pivotal and pilot BE Study - K Vishal, 2017-07-07 11:17
- Pivotal and pilot BE Study - ElMaestro, 2017-07-07 12:05
- Pivotal and pilot BE Study - Ohlbe, 2017-07-07 18:29
  - Pivotal and pilot BE Study - K Vishal, 2017-07-08 09:23
    - Pivotal and pilot BE Study - Helmut, 2017-07-08 14:23
    - Retained samples? - ElMaestro, 2017-07-08 17:01

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