Bioequivalence and Bioavailability Forum

steep exposure-response relationship Mahesh M 2015-10-27 07:01
- steep exposure-response relationship ElMaestro 2015-10-27 09:18
  - steep exposure-response relationship nobody 2015-10-27 10:51

Generic application bkrao 2015-10-16 08:15
- Generic application: submission to multiple authorities Ohlbe 2015-10-16 11:47

Audio video recording of informed consent Ohlbe 2015-08-20 18:03
- Audio video recording of informed consent suchit_bhavsar 2015-08-21 07:30
  - Audio video recording of informed consent sathish.munaga 2015-10-14 12:19

MHRA regulatory issue Melkor 2015-10-11 19:49

Extent of Protocol deviation accepted by the Agency bharathi 2014-09-16 12:19
- Ethics? Helmut 2014-09-16 13:07
  - Ethics? bharathi 2015-10-01 06:57

Metformin FDC MaggieSantos 2015-09-25 19:39
- Metformin FDC Shuanghe 2015-09-28 16:52

New D. Guidance – Dabigatran jag009 2015-09-21 23:19
- New D. Guidance – Dabigatran nobody 2015-09-22 11:04
  - The FDA’s fourth BE approach! Helmut 2015-09-22 11:43
    - The FDA’s fourth BE approach! nobody 2015-09-22 13:06
      - The FDA’s fourth BE approach! Helmut 2015-09-22 13:25
        
        The FDA’s fourth BE approach! Yada Yada Yada jag009 2015-09-23 20:29
        
        Yucky… Helmut 2015-09-23 22:06
    - The FDA’s fourth BE approach! d_labes 2015-09-22 14:08
      - New PowerTOST function(s) Helmut 2015-09-22 14:27
        
        New PowerTOST function(s) d_labes 2015-09-22 14:59
        
        Pradaxa = HVDP (dabigatran = HVD?) Helmut 2015-09-22 15:16
        
        Pradaxa = HVDP (dabigatran = HVD?) Shuanghe 2015-09-22 16:53
        
        HVNTID's d_labes 2015-09-23 08:34
        
        HVNTID's Shuanghe 2015-09-25 16:14
        
        Highly variable NTID d_labes 2015-09-23 08:23
        
        What a mess! Helmut 2015-09-23 13:20
        
        Messy numbers - PowerTOST V1.3-01 preview d_labes 2015-09-24 09:18
        What a mess! Shuanghe 2015-09-25 16:32
      - OT: power.NTIDFDA() Helmut 2015-09-23 00:10
        
        OT: power.NTIDFDA() d_labes 2015-09-23 09:37

Study Protocol guidance (esp. PD) bkrao 2015-09-23 11:53

Delegation of Duties by PI in BA/BE studies ratnakar1811 2015-09-22 09:14
- Delegation of Duties by PI in BA/BE studies ElMaestro 2015-09-22 10:32
- Delegation of Duties by PI in BA/BE studies Dr_Dan 2015-09-22 10:39
  - Delegation of Duties by PI in BA/BE studies Ohlbe 2015-09-22 12:25
- Delegation of Duties by PI in BA/BE studies Dr_Dan 2015-09-23 08:59

In-vitro Dissolution complementary to BE sireen 2013-12-14 12:27
- In-vitro Dissolution complementary to BE Dr_Dan 2013-12-16 12:58
  - In-vitro Dissolution complementary to BE Helmut 2013-12-16 14:50
    - In-vitro Dissolution: Order and questions mittyri 2014-01-22 19:39
      - In-vitro Dissolution: Order and questions Dr_Dan 2014-01-23 11:50
      - In-vitro Dissolution: Order and questions Erkin 2015-09-16 11:24
        
        In vivo ≫ in vitro Helmut 2015-09-16 15:37
        
        In vivo ≫ in vitro Erkin 2015-09-17 08:39
        
        In vivo ≫ in vitro Helmut 2015-09-17 12:41
        
        In vivo ≫ in vitro Shuanghe 2015-09-18 10:11
        
        What about BCS II, (III), IV? Helmut 2015-09-18 12:25

FDA: Hydrocortisone Mahesh M 2015-09-15 08:03
- FDA: Hydrocortisone Mauricio Sampaio 2015-09-16 05:50
  - FDA: Hydrocortisone Mahesh M 2015-09-16 06:50

Zimbabwe Regulatory bkrao 2015-09-02 13:24
- Zimbabwe Regulatory BE-proff 2015-09-02 14:54
  - Sub-Saharan Africa Helmut 2015-09-07 14:22
    - Sub-Saharan Africa Anand 2015-09-08 05:52
      - Sub-Saharan Africa nobody 2015-09-08 10:57
    - Sub-Saharan Africa bkrao 2015-09-10 13:19

Partial Validation chowdary123 2015-09-03 13:29
- Partial Validation BE-proff 2015-09-04 10:32

impact analysis Mitesh Panchal 2015-08-30 20:19

Bio-batch size for suspensions sireen 2015-08-24 05:20

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