Bioequivalence and Bioavailability Forum

archival period of Study documents as Per FDA, ANVISA, EMEA guidelines vivekb2 2018-10-27 07:59

FDA: Size of bio-batch Helmut 2013-12-10 14:05
- FDA: Size of bio-batch jag009 2013-12-10 20:03
  - FDA: antique of ’93 Helmut 2013-12-10 23:32
    - FDA: antique of ’93 jag009 2013-12-11 15:23
      - FDA: antique of ’93 Helmut 2013-12-11 15:26
        
        FDA: antique of ’93 jag009 2013-12-11 16:21
        
        FDA: antique of ’93 Helmut 2013-12-11 16:29
        
        FDA: antique of ’93 jag009 2013-12-11 23:16
        
        Patience Helmut 2013-12-12 14:34
    - FDA: antique of ’93 Beholder 2018-06-21 09:21
      - Nice numbers Helmut 2018-06-21 15:05
        
        Nice numbers Beholder 2018-06-22 10:33
        
        Type II variation Helmut 2018-06-22 15:12
      - Birdsong's third law of BE ElMaestro 2018-06-22 10:10
        
        Experience Beholder 2018-06-22 11:04
        
        Why, oh why? Helmut 2018-06-22 15:17
        
        Sorry for the delay Beholder 2018-10-18 09:40

Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-08 11:34
- BE of parenterals Helmut 2018-10-08 11:53
- Enoxaparin sodium injection BA BE studies nobody 2018-10-09 10:42
  - Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-10 07:09
- Enoxaparin sodium injection BA BE studies ElMaestro 2018-10-09 11:13
  - Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-10 07:11

Retention of BA/BE samples Neelu Singh 2018-10-05 06:57

Pivotal study documentation for submission Amalia 2018-09-24 14:22

Reference Scale Average Bioequivalence Approach: ANVISA, Brazil Maitri 2018-09-21 19:49
- RSABE - ANVISA d_labes 2018-09-22 14:11

Sample size determination for in-vitro superiority study sudy 2018-09-21 08:46

Usage of different lots of RLDs in multistage adaptive studies manusyriac 2018-09-20 09:45
- Usage of different lots of RLDs in multistage adaptive studies ElMaestro 2018-09-20 12:19
  - Usage of different lots of RLDs in multistage adaptive studies manusyriac 2018-09-20 13:05

Endogenous NTI drugs NK 2018-09-19 07:31

FDA Supac guidance for ER jag009 2018-09-07 20:31
- FDA Supac guidance for ER Helmut 2018-09-09 14:04
  - FDA Supac guidance for ER jag009 2018-09-10 18:38

> 5% of Cmax for endogenous molecule? Ramesh Ramalingam 2018-06-18 08:00
- Any own thoughts? Helmut 2018-06-18 10:59
  - carryover effect in endogenous substances Ramesh Ramalingam 2018-08-08 07:29

BE criteria rajasekharkakarla 2018-08-03 09:21
- BE criteria jag009 2018-08-06 20:35

Bioanalysis discontinued subject Johanne 2018-08-02 00:31
- Bioanalysis discontinued subject Helmut 2018-08-02 02:02
- Bioanalysis discontinued subject ElMaestro 2018-08-02 11:14

Reference trademark issue rajasekharkakarla 2018-07-24 09:05
- Note to File Helmut 2018-07-24 16:57
  - Note to File rajasekharkakarla 2018-07-30 13:37

Not using Biostrength for BE zheng791 2018-07-13 21:31
- Not using Biostrength for BE ElMaestro 2018-07-13 22:29
- Not using Biostrength for BE jag009 2018-07-17 06:32
- Not using Biostrength for BE sameep 2018-07-17 06:46

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