Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Bioequivalence criteria for endogenous drug Bioequivalence criteria for endogenous drug	pash413	2012-02-03 12:15	1	2012-02-04 04:31	2,562
DCGI BE-NOC DCGI BE-NOC DCGI BE-NOC DCGI BE-NOC DCGI BE-NOC DCGI BE-NOC	rave04	2012-02-03 06:10	5	2012-02-03 12:19	6,663
unknown linearity linear PK required for biowaiver ... or knowledge of non-linearity ... or knowledge of non-linearity	kudra23	2012-01-30 10:30	3	2012-01-31 17:18	3,068
EMA - Exclusion of data EMA - Exclusion of data EMA - Exclusion of data LSMeans? LSMeans?	d_labes	2012-01-24 11:09	4	2012-01-26 12:22	4,262
Expedited Review from IEC in case of change in study design Expedited Review from IEC in case of change in study design Expedited Review from IEC in case of change in study design New trial = new opinion Sample size: parallel ≠ 2× cross-over! Expedited Review from IEC in case of change in study design Expedited Review from IEC in case of change in study design	amatewadi	2012-01-09 12:46	6	2012-01-22 13:26	4,168
WHO BTIF WHO BTIF WHO BTIF WHO BTIF WHO BTIF WHO BTIF WHO BTIF Inter- or intra-subject CV? intrasubject intrasubject intrasubject	K2K	2012-01-12 05:15	10	2012-01-18 08:36	7,840
bracketing approach	ioanam	2012-01-16 19:06	0		2,996
high fat high calorie breakfast menu for oncolgy patients high fat high calorie breakfast menu for oncolgy patients (Semi)solids’ viscosities	Brijesh Wadekar	2012-01-12 06:07	2	2012-01-13 16:48	3,585
Issue of Alcohol Dose dumping Alcohol induced dose dumping (in vitro, FDA) Alcohol induced dose dumping (in vitro, FDA) Alcohol induced dose dumping (in vitro, FDA)	Chiku	2012-01-11 08:10	3	2012-01-12 15:50	11,932
selected strengths	ioanam	2012-01-11 22:55	0		1,549
BE Study Appropriate or not for I.M formulation BE Study Appropriate or not for I.M formulation ‘Fast’ replies	Neo	2012-01-03 12:55	2	2012-01-06 12:30	3,103
BE study for Indonesia BE study for Indonesia	drchilkoti	2012-01-05 13:06	1	2012-01-06 11:41	2,593
Housing of male and female volunteers in BABE Housing of male and female volunteers in BABE Stat Analysis of male and female volunteers in BABE FDA & ANVISA Stat Analysis of male and female volunteers in BABE	Rohit	2010-02-23 14:59	4	2012-01-05 19:19	4,643
solid dispersion reference not test fed and fasting study?	Yvonne	2012-01-04 12:55	0		1,525
distribution of meals Rest after meals Rest after meals ‘Rest after meals’ or ‘rest of meals’ ‘Rest after meals’ or ‘rest of meals’ meal distribution	kaushik089	2011-12-31 07:49	5	2012-01-04 11:29	3,301