Bioequivalence and Bioavailability Forum

Retention of clinical biosamples / blank matrices vivekb2 2017-02-20 11:12
- Retention of clinical biosamples / blank matrices Ohlbe 2017-02-20 11:51
  - Retention of clinical biosamples / blank matrices jag009 2019-04-23 17:22
    - Retention of clinical biosamples / blank matrices ElMaestro 2019-04-23 18:15
    - Retention of clinical biosamples / blank matrices Ohlbe 2019-04-24 11:54
    - Retention of clinical biosamples / blank matrices Helmut 2019-04-24 12:22

Ethics comittee wisdom 2019-04-23 10:43

Clinical Endpoint Bioequivalence study sury 2019-04-08 13:29
- Clinical Endpoint Bioequivalence study Ohlbe 2019-04-08 15:18
  - Clinical Endpoint Bioequivalence study sury 2019-04-09 06:19
- Scores Helmut 2019-04-08 15:38

FDA Form 1572 rajasekharkakarla 2019-03-27 07:48
- FDA Form 1572 Helmut 2019-03-27 09:56

Draft ICH M10 published Ohlbe 2019-03-03 23:18
- Consultation period? Helmut 2019-03-04 01:08
  - EU/EEA Ohlbe 2019-03-14 23:16
- ICH M10 draft wienui 2019-03-13 18:06
  - Multiple methods within a single trial Ohlbe 2019-03-13 18:21
    - Multiple methods within a single trial wienui 2019-03-13 18:44
      - Multiple methods within a single trial Ohlbe 2019-03-13 19:10
        
        Multiple methods within a single trial wienui 2019-03-13 19:35
        
        Multiple methods within a single trial Ohlbe 2019-03-13 23:01
  - one study, one method Helmut 2019-03-13 18:23

WHO draft guidance on good chromatography practices Ohlbe 2019-03-12 11:45

History lessons - FDA BE 90% CI jag009 2019-02-25 22:03
- History lessons - FDA BE 90% CI nobody 2019-02-25 22:39
  - History lessons - FDA BE 90% CI Helmut 2019-02-26 00:44
    - History lessons - FDA BE 90% CI jag009 2019-02-26 15:19
      - History lessons - FDA BE 90% CI nobody 2019-02-26 16:07
      - Strange result Helmut 2019-02-28 12:03
        
        Strange result nobody 2019-03-01 08:50
        
        Pandora's box? jag009 2019-03-01 17:40
        
        Confusing Helmut 2019-03-02 15:37
        
        Strange result jag009 2019-03-01 17:44
        
        Transformation, acceptance range Helmut 2019-03-02 15:09
        
        Transformation, acceptance range nobody 2019-03-02 16:42

inter-batch variability? Dr_Dan 2010-08-04 10:29
- inter-batch variability? Pavidus 2010-08-04 11:57
- inter-batch variability? d_labes 2010-08-04 13:58
- inter-batch variability? ElMaestro 2010-08-04 17:09
  - Between study variability common for HVDs Helmut 2010-08-04 19:45
    - Between study variability common for HVDs ElMaestro 2010-08-04 21:01
      - Representative batches? Helmut 2010-08-04 23:42
        
        Representative batches? ElMaestro 2010-08-05 08:40
        
        Representative batches? Helmut 2010-08-05 12:30
        
        Representative batches? Dr_Dan 2010-08-05 08:58
        
        Representative batches? Helmut 2010-08-05 12:45
        
        Confidence intervals vs. point estimators Dr_Dan 2010-08-06 09:55
        
        Confidence intervals vs. point estimators ElMaestro 2010-08-06 12:34
        
        Confidence intervals vs. point estimates Helmut 2010-08-06 13:20
        Confidence intervals vs. point estimators Dr_Dan 2010-08-06 14:44
        
        Confidence intervals vs. point estimators ElMaestro 2010-08-06 15:01
        
        meta analysis? martin 2010-08-06 17:25
        
        meta analysis? ElMaestro 2010-08-06 17:57
        
        meta analysis? Helmut 2010-08-06 18:31
        
        meta analysis? Ohlbe 2010-08-06 23:21
        
        No chance against RMS? Dr_Dan 2010-08-10 12:27
        
        No chance against RMS? ElMaestro 2010-08-10 16:26
  - Batch-to-Batch Pharmacokinetic Variability kumarnaidu 2016-07-20 07:16
    - tlast (Common) Helmut 2016-07-20 10:48
      - tlast (Common) nobody 2019-02-21 15:20
        
        tlast (Common) ElMaestro 2019-02-21 16:32
        
        tlast (Common) nobody 2019-02-21 17:02
        
        tlast (Common) ElMaestro 2019-02-21 18:02
        
        tlast (Common) nobody 2019-02-21 18:17

Health Canada Study reports anky1212 2019-02-21 05:05

Trinidad and Tobago Bio-equivalence guidelines varun9461 2019-02-18 11:56

Dabigatran EMA - product-specific guide nobody 2019-02-13 18:58
- Dabigatran EMA - product-specific guide ElMaestro 2019-02-13 22:59
  - OT: A major loss Helmut 2019-02-14 00:24
    - OT: A major loss nobody 2019-02-14 09:31
      - OT: A major loss Helmut 2019-02-14 11:37
        
        OT: A major loss nobody 2019-02-14 13:40
- Dabigatran EMA - product-specific guide Helmut 2019-02-14 12:12
  - Dabigatran EMA - product-specific guide nobody 2019-02-14 13:34
    - Dabigatran EMA - product-specific guide Helmut 2019-02-14 13:52
      - Dabigatran EMA - product-specific guide nobody 2019-02-14 15:01

in-vitro population bioequivalence kumarnaidu 2019-02-06 06:50
- in-vitro population bioequivalence ElMaestro 2019-02-06 08:55

In-vitro Population Bioequivalence kumarnaidu 2019-02-05 15:32

"Annex III: To procedure for (...)": I am so confused :-) ElMaestro 2019-01-17 17:18
- "Annex III: To procedure for (...)": I am so confused :-) nobody 2019-01-17 17:41
- Bonus questions ElMaestro 2019-01-17 18:25
  - Bonus questions nobody 2019-01-17 19:00
  - Bonus questions Ohlbe 2019-01-18 21:26
- "Annex III: To procedure for (...)": I am so confused :-) Ohlbe 2019-01-18 21:05

EMA guideline - Trial Master File suchit_bhavsar 2018-12-19 06:09