Bioequivalence and Bioavailability Forum

DCGI BENOC Application alagu 2013-09-07 11:24

IEC approval window period suchit_bhavsar 2013-09-06 08:22
- IEC approval expiry date Dr_Dan 2013-09-06 10:53
- changed requirements Helmut 2013-09-06 13:43
- IEC approval window period raghu 2013-09-06 13:53

Russia Guidance – BE Karthikeyan 2013-09-02 05:55
- Russia Guidance – BE drgunasakaran1 2013-09-02 06:14
  - Russia Guidance – BE Karthikeyan 2013-09-02 06:21
    - Russia: Toxicity data required Helmut 2013-09-02 10:31
      - Russia: Toxicity data required mittyri 2013-09-02 14:18
        
        Russia: Toxicity data required Karthikeyan 2013-09-03 08:48
        
        Russia: Toxicity data required mittyri 2013-09-03 09:26
        
        Toxicity data: why? Helmut 2013-09-03 13:02
        Russia: Toxicity data required Karthikeyan 2013-09-04 06:46
        
        Russia: Toxicity data required mittyri 2013-09-04 08:58
        
        Federal Law # 61–FZ “On circulation of drugs” Helmut 2013-09-05 00:09
        
        Federal Law # 61–FZ “On circulation of drugs” Karthikeyan 2013-09-05 13:52
        
        # 61–FZ adopted 24 March 2010 Helmut 2013-09-05 15:21
        
        # 61–FZ adopted 24 March 2010 Karthikeyan 2013-09-06 06:32
        
        # 61–FZ adopted 24 March 2010 mittyri 2013-09-06 07:22
- Russia Guidance – BE Dr_Dan 2013-09-03 14:40
  - Russia Guidance – BE Helmut 2013-09-03 14:45
    - Russia Guidance – BE Dr_Dan 2013-09-03 19:27
      - ги́бкость Helmut 2013-09-03 21:16
        
        Flexibility Dr_Dan 2013-09-04 10:20
        
        Cultural ∆ Helmut 2013-09-04 14:30
      - Russia Guidance – BE mittyri 2013-09-04 09:15

Ezetimibe: Parent vs Metabolite data Srinetram 2013-09-03 09:16
- Ezetimibe: Parent vs Metabolite data Dr_Dan 2013-09-03 10:44

Truncate 72 hrs for ANVISA Dr RCG 2013-08-30 06:58
- Truncate 72 hrs for ANVISA drgunasakaran1 2013-08-31 05:46
- Truncate 72 hrs for ANVISA Mauricio Sampaio 2013-09-02 06:43

MENA Guideline Abhay 2013-08-28 13:40
- No MENA Guideline Helmut 2013-08-28 14:13

Plasma sample storage as per regulatory perspective? alagu 2013-08-20 13:00
- Plasma sample storage as per regulatory perspective? Ohlbe 2013-08-20 13:51
  - Plasma sample storage as per regulatory perspective? jag009 2013-08-20 18:10
    - Plasma sample storage as per regulatory perspective? Ohlbe 2013-08-20 19:16
      - Plasma sample storage as per regulatory perspective? jag009 2013-08-20 19:51
        
        Plasma sample storage as per regulatory perspective? Ohlbe 2013-08-21 10:07

EMEA perspective: Cmax less than 5% for Test Product luvblooms 2013-08-20 07:01
- EMA perspective: Cmax less than 5% for Test Product d_labes 2013-08-20 08:28
  - EMA perspective: Cmax less than 5% for Test Product luvblooms 2013-08-20 10:22
  - EMA perspective: Cmax less than 5% for Test Product Dr_Dan 2013-08-20 14:21

Retention Sample for EU alagu 2013-08-20 13:01
- Retention Sample for EU Ohlbe 2013-08-20 13:54

Alcohol dose dumping on Amphetamine ER products jag009 2013-08-16 20:25
- Alcohol induced dose-dumping (EMA in general) Helmut 2013-08-17 00:17
  - Alcohol induced dose-dumping (EMA in general) jag009 2013-08-19 15:08

Sensitivity vs. multiple doses Dr_Dan 2013-08-14 12:27
- Sensitivity vs. multiple doses ElMaestro 2013-08-14 13:09

RLD selection for Europe / Canada alagu 2013-08-14 10:27
- RLD selection for Europe / Canada Dr_Dan 2013-08-14 11:40
  - RLD selection for Europe / Canada alagu 2013-08-14 11:55

TGA submission studies avinash 2013-08-13 11:12

all guidelines siva2013 2013-08-09 08:42
- all guidelines drgunasakaran1 2013-08-10 07:18

BE using non RLD zheng791 2013-08-03 21:45
- BE using non RLD ElMaestro 2013-08-03 22:17
  - BE using non RLD jag009 2013-08-03 22:51
    - BE using non RLD zheng791 2013-08-03 23:55
      - BE using non RLD jag009 2013-08-04 20:20
        
        BE using non RLD luvblooms 2013-08-05 05:57
        
        BE using non RLD ElMaestro 2013-08-05 10:44
        
        BE using non RLD luvblooms 2013-08-05 13:46
        
        BE using non RLD ElMaestro 2013-08-05 13:59
        
        BE using non RLD luvblooms 2013-08-05 14:31
        
        BE using non RLD ElMaestro 2013-08-05 15:04
        Very strange! jag009 2013-08-05 16:02
        
        Very strange! Helmut 2013-08-05 16:37
        
        Very strange! jag009 2013-08-05 16:45
        
        Very strange! luvblooms 2013-08-05 17:30
        
        Very strange! jag009 2013-08-05 17:52

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