Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
DCGI BENOC Application	alagu	2013-09-07 11:24	0		2,037
IEC approval window period IEC approval expiry date changed requirements IEC approval window period	suchit_bhavsar	2013-09-06 08:22	3	2013-09-06 11:53	3,666
Russia Guidance – BE Russia Guidance – BE Russia Guidance – BE Russia: Toxicity data required Russia: Toxicity data required Russia: Toxicity data required Russia: Toxicity data required Toxicity data: why? Russia: Toxicity data required Russia: Toxicity data required Federal Law # 61–FZ “On circulation of drugs” Federal Law # 61–FZ “On circulation of drugs” # 61–FZ adopted 24 March 2010 # 61–FZ adopted 24 March 2010 # 61–FZ adopted 24 March 2010 Russia Guidance – BE Russia Guidance – BE Russia Guidance – BE ги́бкость Flexibility Cultural ∆ Russia Guidance – BE	Karthikeyan	2013-09-02 05:55	21	2013-09-06 05:22	12,828
Ezetimibe: Parent vs Metabolite data Ezetimibe: Parent vs Metabolite data	Srinetram	2013-09-03 09:16	1	2013-09-03 08:44	4,089
Truncate 72 hrs for ANVISA Truncate 72 hrs for ANVISA Truncate 72 hrs for ANVISA	Dr RCG	2013-08-30 06:58	2	2013-09-02 04:43	3,594
MENA Guideline No MENA Guideline	Abhay	2013-08-28 13:40	1	2013-08-28 12:13	3,131
Plasma sample storage as per regulatory perspective? Plasma sample storage as per regulatory perspective? Plasma sample storage as per regulatory perspective? Plasma sample storage as per regulatory perspective? Plasma sample storage as per regulatory perspective? Plasma sample storage as per regulatory perspective?	alagu	2013-08-20 13:00	5	2013-08-21 08:07	4,149
EMEA perspective: Cmax less than 5% for Test Product EMA perspective: Cmax less than 5% for Test Product EMA perspective: Cmax less than 5% for Test Product EMA perspective: Cmax less than 5% for Test Product	luvblooms	2013-08-20 07:01	3	2013-08-20 12:21	3,595
Retention Sample for EU Retention Sample for EU	alagu	2013-08-20 13:01	1	2013-08-20 11:54	3,064
Alcohol dose dumping on Amphetamine ER products Alcohol induced dose-dumping (EMA in general) Alcohol induced dose-dumping (EMA in general)	jag009	2013-08-16 20:25	2	2013-08-19 13:08	5,633
Sensitivity vs. multiple doses Sensitivity vs. multiple doses	Dr_Dan	2013-08-14 12:27	1	2013-08-14 11:09	2,343
RLD selection for Europe / Canada RLD selection for Europe / Canada RLD selection for Europe / Canada	alagu	2013-08-14 10:27	2	2013-08-14 09:55	3,819
TGA submission studies	avinash	2013-08-13 11:12	0		1,603
all guidelines all guidelines	siva2013	2013-08-09 08:42	1	2013-08-10 05:18	2,685
BE using non RLD BE using non RLD BE using non RLD BE using non RLD BE using non RLD BE using non RLD BE using non RLD BE using non RLD BE using non RLD BE using non RLD BE using non RLD Very strange! Very strange! Very strange! Very strange! Very strange!	zheng791	2013-08-03 21:45	15	2013-08-05 15:52	7,075