Bioequivalence and Bioavailability Forum

FDA Submission: Failed and pilot studies jag009 2013-10-01 15:14
- FDA Submission: Failed and pilot studies Ohlbe 2013-10-01 15:41
  - FDA Submission: Failed and pilot studies jag009 2013-10-01 16:33

Conflict of Interest sparsh 2013-09-24 12:50
- Conflict of Interest Dr_Dan 2013-09-24 14:49
  - Conflict of Interest sparsh 2013-09-25 05:31

Canada BE limits Naveen Kumar 2013-09-23 14:35
- Canada BE limits Helmut 2013-09-23 15:08

BE study for Tablet vs Sachet sparsh 2013-09-21 11:24
- BE study for Tablet vs Sachet Dr_Dan 2013-09-22 16:53

clinical trials/ BE studies for locally acting drugs jagankm 2012-01-25 11:26
- clinical trials/ BE studies for locally acting drugs drgunasakaran1 2012-01-31 18:42
  - clinical trials/ BE studies for locally acting drugs Ohlbe 2012-01-31 19:01
    - clinical trials/ BE studies for locally acting drugs jagankm 2012-02-06 12:00
      - clinical trials/ BE studies for locally acting drugs Tina 2013-09-16 18:10
  - clinical trials/ BE studies for locally acting drugs Tina 2013-09-19 09:45

biobatch size and scale up Elena 2013-09-17 10:06
- Type II Variation Helmut 2013-09-17 16:36
  - Type II Variation Elena 2013-09-18 08:42
    - Type II Variation Dr_Dan 2013-09-18 10:01
      - Type II Variation Ohlbe 2013-09-18 12:41
      - Type II Variation Elena 2013-09-18 12:55

Blank Plasma sparsh 2013-09-18 10:19

Draft EMA MR formulations GL published! Ohlbe 2013-03-15 12:10
- Housekeeping suggestions Helmut 2013-03-15 13:28
- Scaling for pAUCs Helmut 2013-03-15 14:19
- Draft EMA MR formulations GL published! ioanam 2013-03-30 17:54
  - Topicals → 1995 NfG Helmut 2013-03-30 22:51
  - Topicals, generic ElMaestro 2013-03-31 19:26
    - Topicals, generic ioanam 2013-04-01 07:51
      - Topicals, generic The Outlaw Torn 2013-04-01 08:03
- Clarity on waiving multiple dose study Tina 2013-05-15 14:19
  - Hey, it is just a draft! Helmut 2013-05-17 18:49
    - Critical review of García-Arieta et al. (2012) Helmut 2013-06-29 19:44
- SD vs. MD, partial AUCs Helmut 2013-06-21 19:24
  - SD vs. MD, partial AUCs Shuanghe 2013-06-25 17:22
    - SD vs. MD, partial AUCs Helmut 2013-06-25 19:15
      - SD vs. MD, partial AUCs Shuanghe 2013-06-27 11:07
        
        pAUCs, alternative metrics, alcohol Helmut 2013-06-27 14:38
- tmax (DR & multiphasic) Helmut 2013-06-22 01:15
- Presentations of the EUFEPS meeting Helmut 2013-07-15 15:50
- ⧫ Deadline approaching ⧫ Helmut 2013-08-16 16:41
  - Download comment form Helmut 2013-08-26 11:28
- Food effect Compliance 2013-08-26 12:04
  - Food effect Dr_Dan 2013-08-26 16:48
- Variability (MR vs. IR) Helmut 2013-09-12 15:23

Development Safety Update Report requirement Tina 2013-09-12 14:20

Sample size vasup 2013-07-29 08:37
- Sample size ElMaestro 2013-07-29 10:00
- Sample size jag009 2013-07-29 15:57
- Overpowering Helmut 2013-07-30 15:51
  - Overpowering ElMaestro 2013-07-30 16:37
    - Overpowering jag009 2013-07-30 16:45
      - Overpowering ElMaestro 2013-07-30 16:51
        
        Overpowering jag009 2013-08-01 20:08
        
        Overpowering kumarnaidu 2013-09-02 12:22
        
        Conservative study planning Helmut 2013-09-02 12:42
        
        Conservative study planning kumarnaidu 2013-09-02 14:36
        
        Conservative study planning Ohlbe 2013-09-02 18:44
        
        confidence limit of the CV Jay 2013-09-06 13:55
        
        CL of CV Helmut 2013-09-06 15:02
        
        CL of CV Jay 2013-09-06 15:21
        
        CL of CV Helmut 2013-09-06 15:42
        
        PE consideration Jay 2013-09-11 11:02
        
        PE consideration Dr_Dan 2013-09-11 12:07
        
        PE consideration Jay 2013-09-11 13:09
        PE consideration kumarnaidu 2013-09-11 13:22
        
        Sockpuppet? Helmut 2013-09-11 14:13
        PE consideration kumarnaidu 2013-09-12 13:04

Waiving of md study in MR combination product Dr_Dan 2013-09-11 14:42
- Still a draft! Helmut 2013-09-11 14:51

Fluticasone/Salmeterol FDA guidance ElMaestro 2013-09-10 16:54
- Fluticasone/Salmeterol FDA guidance Dr_Dan 2013-09-11 12:13

Nicergoline ioanam 2013-09-07 21:55
- Nicergoline Dr_Dan 2013-09-09 10:15
  - Nicergoline ioanam 2013-09-10 14:42

Bioequivalence study of Sulfasalazine for Chile manojskr 2013-09-09 15:10

Europe/USA/Canada alagu 2013-09-07 11:34
- Homework Helmut 2013-09-07 14:25

Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
124 visitors (0 registered, 124 guests [including 27 identified bots]).
Forum time: 00:31 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder. Laurence J. Peter

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz