Bioequivalence and Bioavailability Forum

“Before bioanalysis” interpretation – exclusion of subjects Dirk 2012-12-03 00:14
- “Before bioanalysis” interpretation – exclusion of subjects Dr_Dan 2012-12-03 12:56
  - “Before bioanalysis” interpretation – exclusion of subjects Helmut 2012-12-03 13:43
    - “Before bioanalysis” interpretation – exclusion of subjects Dr_Dan 2012-12-03 16:39
      - “Before bioanalysis” interpretation – exclusion of subjects Dirk 2012-12-04 02:52
        
        “Before bioanalysis” – exclusion of subjects d_labes 2012-12-04 08:33
        
        “Before bioanalysis” – exclusion of subjects lukamar 2012-12-04 10:11
        
        “Before bioanalysis” – exclusion of subjects Dirk 2012-12-05 14:04

change of name in investigational products vivekanand 2012-11-24 14:40
- change of name in investigational products drgunasakaran1 2012-11-24 15:06
- change of name in investigational products Dr RCG 2012-11-24 16:01
  - change of name in investigational products drgunasakaran1 2012-11-24 17:36
    - Bad idea, IMHO Helmut 2012-11-24 18:15
      - Bad idea, IMHO drgunasakaran1 2012-11-27 14:25

EMEA CI on treatment, period & sequence effects qwerty12 2012-11-26 22:11
- EMA: no CI on period & sequence effects Helmut 2012-11-26 22:39
  - EMA: no CI on period & sequence effects qwerty12 2012-11-26 23:16
    - EMA: Veterinary (!) BE Helmut 2012-11-26 23:59

Two topical gel formulations with one oral tablet yogesh1004 2012-11-19 12:16

Replicate study design for Brazil submission balakotu 2012-11-14 09:49
- ANVISA – likely no scaling Helmut 2012-11-14 15:02
  - ANVISA – likely no scaling luvblooms 2012-11-16 05:27
    - ANVISA: strange Helmut 2012-11-16 14:14

Retention requirements for comparator AUClast 2012-11-08 18:46
- Retention requirements for comparator drgunasakaran1 2012-11-09 02:31
  - Retention requirements for comparator AUClast 2012-11-09 11:24

Retention quantity for Europe Submission study achintparikh 2012-11-03 12:44
- Retention quantity for Europe Submission study drgunasakaran1 2012-11-03 13:02
  - Retention quantity for Europe Submission study achintparikh 2012-11-07 06:01

Tox studies before generic BE Helmut 2012-11-04 17:25
- Tox studies before generic BE drgunasakaran1 2012-11-05 10:02
  - Yes, but why the heck? Helmut 2012-11-05 12:04
    - Clearly because... ElMaestro 2012-11-05 13:08
    - Yes, but why the heck? drgunasakaran1 2012-11-06 04:43

IEC Registration santosh 2012-11-02 13:19
- IEC Registration drgunasakaran1 2012-11-02 17:42

Need Help: History lessons on FDA BABE jag009 2012-10-23 21:19
- Need Help: History lessons on FDA BABE drgunasakaran1 2012-10-24 13:02

Does Inhalation Aerosol require BE? Jasim Uddin 2012-10-22 07:16
- Does Inhalation Aerosol require BE? ElMaestro 2012-10-22 11:11
  - Does Inhalation Aerosol require BE? Jasim Uddin 2012-10-22 11:25
    - Does Inhalation Aerosol require BE? ElMaestro 2012-10-22 11:30
    - Does Inhalation Aerosol require BE? jag009 2012-10-22 23:27

Statistical analysis (ANVISA) k1612 2012-10-18 18:59

Tmax differences in BE studies jag009 2012-10-15 16:23
- Delayed release? Helmut 2012-10-15 16:41
  - Delayed release? jag009 2012-10-15 19:38
    - CR? Helmut 2012-10-15 19:59
      - CR? Ohlbe 2012-10-15 22:54
        
        t75%, HVD Helmut 2012-10-16 14:06
      - CR? jag009 2012-10-16 21:22

Steady State Study Criteria for Pre-dose sandipmumbai 2012-10-16 09:13
- Steady State Study Criteria for Pre-dose Helmut 2012-10-16 15:18

SAE reporting Compliance 2012-10-12 08:18
- SAE reporting drgunasakaran1 2012-10-13 21:23

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