Bioequivalence and Bioavailability Forum

BE studies requirements satishpsm 2014-11-05 09:29
- BE studies requirements priya 2014-11-05 10:50
  - BE studies requirements VK 2014-11-06 13:35
    - BE studies with clinical endpoints-study population Tina 2014-11-07 12:12
      - Homework Helmut 2014-11-07 15:31

BE NOC Regulatory Check list for rsr 2014-11-03 06:07
- BE NOC Regulatory Check list for priya 2014-11-03 09:44
  - BE NOC Regulatory Check list for rsr 2014-11-03 09:47

Incurred sample reanalysis sarada06884 2013-04-09 12:22
- Incurred sample reanalysis Ohlbe 2013-04-09 14:09
  - Incurred sample reanalysis The Outlaw Torn 2013-04-10 08:40
    - Clopidogrel Ohlbe 2013-04-10 10:34
      - Clopidogrel The Outlaw Torn 2013-04-10 11:31
        
        Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 17:01
        
        Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-22 18:56
        
        Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 19:35
        
        "Meth" - apologies ElMaestro 2013-04-22 20:03
        
        "Meth" - apologies The Outlaw Torn 2013-04-23 08:27
        
        "Meth" - apologies ElMaestro 2013-04-23 14:29
        
        "ISR" - apologies The Outlaw Torn 2013-04-24 07:44
        
        Repeat use ElMaestro 2013-04-24 11:08
        
        Repeat use Ohlbe 2013-04-24 11:41
        
        Repeat use ElMaestro 2013-04-24 13:45
        
        "ISR" – resolved Helmut 2013-09-20 21:50
        
        "ISR" – resolved Dr_Dan 2013-09-22 16:56
        
        Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-23 23:31
        
        Some more stuff Helmut 2013-04-24 02:08
        Lack of ISR / only 5% ISR in study with 656 samples nobody 2014-10-23 10:06

Dispersible Tablets Ahmed Al Habashi 2014-10-20 12:10
- Dispersible Tablets Dr_Dan 2014-10-23 09:31

Validity of BE wien-ui 2014-10-22 19:02
- No “shelf life”, but… Helmut 2014-10-22 19:33
- Validity of BE Dr_Dan 2014-10-23 09:24

ODF (Oral Dispersible Films)-BE Ahmed Al Habashi 2014-10-20 12:09
- ODF (Oral Dispersible Films)-BE Helmut 2014-10-20 13:08

Desmopressin Acetate RLD confirmation USFDA Anand 2014-10-17 06:34
- Desmopressin Acetate RLD confirmation USFDA priya 2014-10-17 11:56
- We are not hearing &| visually impaired Helmut 2014-10-17 16:47

Therapeutic Code; None in USFDA Anand 2014-10-17 06:29
- Therapeutic Code; None in USFDA priya 2014-10-17 15:57

Test Product Shape & Colour Changes in Europe Anand 2014-10-17 06:24

Current BE guideline India? nobody 2014-10-14 11:44
- Current BE guideline India? nobody 2014-10-15 11:42
  - Confirmation pending Helmut 2014-10-15 13:04
    - Confirmation pending nobody 2014-10-16 18:38
      - Terrible… Helmut 2014-10-16 21:16
        
        Terrible… nobody 2014-10-16 21:31

Tablet Scoring: A must for Generic Companies? luvblooms 2014-10-14 10:52
- Tablet Scoring: A must for Generic Companies? jag009 2014-10-14 16:54

Teriminal partial AUC for Metformin ER Tablets Naveen Kumar 2014-09-10 12:34
- Teriminal partial AUC for Metformin ER Tablets jag009 2014-09-10 19:51
  - Teriminal partial AUC for Metformin ER Tablets Naveen Kumar 2014-09-11 06:15
    - Teriminal partial AUC for Metformin ER Tablets jag009 2014-09-11 20:07
      - Epilim Chrono 500 CR tablets kumarnaidu 2014-10-13 12:39

Rechallenge (or re-dosing) study jag009 2014-10-01 20:53
- Rechallenge (or re-dosing) study luvblooms 2014-10-07 07:51
  - Rechallenge (or re-dosing) study jag009 2014-10-08 15:51
    - Rechallenge (or re-dosing) study luvblooms 2014-10-09 06:10

BE study for Egypt submission Debbie 2014-09-29 12:47

Phenytoin BE Limits prashantmohite 2014-09-11 15:20
- Phenytoin BE Limits Ohlbe 2014-09-11 17:57
  - The other way around? ElMaestro 2014-09-11 19:00
    - Narrowing, widening and typos Ohlbe 2014-09-11 19:25
      - Narrowing, widening and typos prashantmohite 2014-09-12 06:21
        
        Narrowing, widening and typos nobody 2014-09-12 10:30
        
        Narrowing, widening and typos kvgreddy06 2014-09-13 07:18
        
        FDA: phenytoin = NTID? Helmut 2014-09-14 15:24
        
        FDA: phenytoin = NTID? kvgreddy06 2014-09-26 14:17
        
        AUC more critical? Helmut 2014-09-14 15:42
        
        AUC more critical? nobody 2014-09-14 18:31
        
        Narrowing, widening and typos Helmut 2014-09-14 15:39
        
        Narrowing, widening and typos prashantmohite 2014-09-15 07:31

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