Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Regulatory Documents	Rajdeep	2010-05-18 06:31	0		1,950
US FDA Form 1572 US FDA Form 1572 US FDA Form 1572 US FDA Form 1572 US FDA Form 1572	kiranActimus	2010-05-09 16:47	4	2010-05-11 08:22	5,255
upper limit blood loss upper limit blood loss upper limit blood loss	maverick	2010-04-27 11:08	2	2010-04-28 07:36	6,649
EMA BE guideline - final version Final version published Final version published Statistix Statistix Calories ;-) Calories ;-) Calories ;-) Variable calories ANOVA only - no doubts ANOVA only - no doubts Final EMA oracle Final EMA oracle Final EMA oracle More then two EMA oracles Less of an issue Less or More of an issue Less or More of an issue Effective with 1 Aug 2010 Bias? Bias? Bias? Bias? Bias? Bias? Bias? Final EMA oracle Final EMA oracle Final EMA oracle Teaching Cmin really gone? tmax reappeared? Cmin really gone. tmax reappeared - but how? Interpol or not Interpol! Interpol! WinNonlin/Phoenix extrapolation to t=tau Meta-analysis Final version published Cmin for MR-formulations? Cmin for MR-formulations? MR-Guideline? Overview of comments published Comments commented Definition of Cmin by EMEA The EMA’s Cmin & WinNonlin	Ohlbe	2010-01-28 18:31	44	2010-04-23 10:34	32,240
IM injection IM injection IM injection IM injection IM injection IM: absorption site! IM: absorption site! IM: absorption site! IM: absorption site! IM: absorption site! IM: absorption site! Quality of the questions asked.	ray_be	2010-03-24 06:32	11	2010-04-17 20:20	12,490
ISR ISR ISR ISR ISR	Shastris	2010-04-14 06:13	4	2010-04-16 08:06	3,198
Blinded QC samples Blinded QC samples Blinded QC samples	IK	2010-04-12 05:46	2	2010-04-13 03:05	2,594
Vitamin K2-Menaquinone 7	Rajdeep	2010-04-05 11:46	0		15,614
pk parameters Malaysia, PK metrics Malaysia, PK metrics	shri	2010-04-03 11:50	2	2010-04-05 05:44	2,368
three consecutive missing samples 1. Science, 2. Guidelines	yuvrajkatkar	2010-04-03 08:40	1	2010-04-03 12:14	2,763
ANVISA guidance ANVISA guidance ANVISA guidance Bioanalysis of dropouts, etc.	Priyanka_S	2010-03-20 11:09	3	2010-04-01 13:56	6,000
Correction to EMA Final BE-GL Correction to EMA Final BE-GL Correction to EMA Final BE-GL Correction to EMA Final BE-GL (for IR dosage forms)	Helmut	2010-03-28 17:28	3	2010-03-29 11:55	5,272
Kel Determination Kel and R2	Madhavi	2010-03-23 11:14	1	2010-03-23 11:08	5,291
US FDA-Cmin in Bioequivalence criteria US FDA-Cmin in Bioequivalence criteria	hitesh_chauhan	2010-03-19 12:46	1	2010-03-19 13:26	2,717
X-Ray film storage X-Ray film storage	chirayu	2010-03-16 12:58	1	2010-03-17 10:38	2,836