Bioequivalence and Bioavailability Forum

Bioequivalence Acceptance criteria for in-vitro binding study in EMA submission Biostats 2020-01-24 08:19

Bioequivalence of racemic drugs using non-steriospecific bio scorp2011 2012-01-12 13:21
- BE of racemic drugs (EMA vs. FDA) Helmut 2012-01-12 19:21
  - BE of racemic drugs (EMA vs. FDA) scorp2011 2012-01-13 06:11
    - BE of racemic drugs (EMA’s practice) Helmut 2012-01-13 16:02
      - BE of racemic drugs (EMA’s practice) scorp2011 2012-01-16 13:08
        
        BE of racemic drugs (EMA’s practice) valivetiananth 2019-12-30 13:45
        
        BE of racemic drugs (EMA’s practice) Helmut 2019-12-30 14:35

Significance of Ctau,ss in steady state study Biostats 2019-12-20 07:51
- Relevance of Cτ,ss Helmut 2019-12-20 12:46

biowaiver requirement for APAC (Asia Pacific) jag009 2019-12-18 04:45

Informed Consent Document Review suchit_bhavsar 2019-12-11 11:22
- Informed Consent Document Review Ohlbe 2019-12-11 16:58
- Informed Consent Document Review WhiteCoatWriter 2019-12-11 19:36

Clarification from Russian expert organization regarding telmisartan BE studies Beholder 2019-11-08 07:51
- Clarification from Russian expert organization… Helmut 2019-11-08 15:35
  - Questions mittyri 2019-11-08 22:00
    - Guesses & answers Helmut 2019-11-09 11:36
      - intergender differences and consequences mittyri 2019-12-04 08:53
        
        intergender differences and no consequences Helmut 2019-12-04 11:23
    - Questions Yura 2019-12-04 12:16
      - Questions Yura 2019-12-04 14:14
      - Careful PharmCat 2019-12-10 18:53
- Confusion from Russian expert organization Helmut 2019-12-03 12:19
- Clarification from Russian expert organization regarding telmisartan BE studies Mikalai 2019-12-09 18:27

NDA study for Mexico jag009 2019-12-06 16:19
- Cmax ER = Cmax IR ? Helmut 2019-12-06 16:41
  - Cmax ER = Cmax IR - the only option mittyri 2019-12-06 17:08
    - Cmax ER = Cmax IR - the only option Helmut 2019-12-06 17:36
  - Cmax ER = Cmax IR ? jag009 2019-12-06 17:38
    - Cmax ER = Cmax IR ? Helmut 2019-12-06 17:45
      - Cmax ER = Cmax IR ? jag009 2019-12-06 21:21
        
        Cmax ER = Cmax IR ? Yura 2019-12-06 22:40
        
        Cmax ER = Cmax IR ? jag009 2019-12-09 18:15

Generic submission in India jag009 2019-11-11 21:43
- Dead silence in India Helmut 2019-11-21 14:01
- Generic submission in India Ajit Thorat 2019-12-09 13:29

Active metabolites: to measure or not to measure Elena777 2019-12-05 20:34
- Active metabolites: to measure or not to measure ElMaestro 2019-12-05 23:22
  - Parent only. Chiral assay? Helmut 2019-12-06 00:26

EMA Q&A vs EMA Product Specific guideline Averroes 2017-10-04 12:01
- Crushed Rivaroxaban? Averroes 2018-01-09 12:00
  - Crushed Rivaroxaban? lukamar 2018-08-20 12:24
    - specific BE study with administration of crushed/disintegrated tablet wienui 2019-12-03 18:20

necessity of retention samples for pilot BE study Shuanghe 2019-11-25 13:05
- necessity of retention samples for pilot BE study Ohlbe 2019-11-25 15:16
  - necessity of retention samples for pilot BE study Shuanghe 2019-11-25 18:00
- necessity of retention samples for pilot BE study ElMaestro 2019-11-25 17:38
  - necessity of retention samples for pilot BE study Shuanghe 2019-11-25 18:42
  - necessity of retention samples for pilot BE study nobody 2019-11-26 10:11

Furosemide oral tablet Ibrahim Komeil 2019-11-18 09:03

IS response variations Ohlbe 2019-09-04 19:03
- IS response variations nobody 2019-09-06 16:21
- More on IS response variations Ohlbe 2019-11-12 11:32
  - More on IS response variations ElMaestro 2019-11-12 12:27
    - More on IS response variations Helmut 2019-11-12 13:24
      - More on IS response variations ElMaestro 2019-11-12 13:38
        
        More on IS response variations Helmut 2019-11-12 13:41
      - More on IS response variations Ohlbe 2019-11-12 13:56
        
        More on IS response variations ElMaestro 2019-11-12 16:25
        
        More on IS response variations Ohlbe 2019-11-12 18:14
        
        More on IS response variations ElMaestro 2019-11-12 18:39
        
        Not more on IS response variations Ohlbe 2019-11-13 00:06
        
        Not more on IS response variations nobody 2019-11-13 10:06
        
        the run passes = there is no problem? ElMaestro 2019-11-13 17:35
        
        the run passes = there is no problem? nobody 2019-11-13 19:17

Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Nidhiya J S 2019-11-05 06:14
- Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet jag009 2019-11-07 19:52
  - Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Nidhiya J S 2019-11-11 10:51
- Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet wienui 2019-11-08 07:14
  - Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Nidhiya J S 2019-11-11 10:51

standby and retention samples zeynep 2019-10-24 12:22
- standby and retention samples Ohlbe 2019-10-24 13:34
  - standby and retention samples zeynep 2019-10-24 14:21
    - Reserve samples? Helmut 2019-10-24 14:32
      - Spare subjects? ElMaestro 2019-10-24 14:38
        
        Spare subjects? Ohlbe 2019-10-24 17:59
        Spare subjects? jag009 2019-10-24 19:39
    - standby and retention samples Ajit Thorat 2019-10-30 11:31

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