Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
FDA Submission: Failed and pilot studies FDA Submission: Failed and pilot studies FDA Submission: Failed and pilot studies	jag009	2013-10-01 15:14	2	2013-10-01 14:33	3,646
Conflict of Interest Conflict of Interest Conflict of Interest	sparsh	2013-09-24 12:50	2	2013-09-25 03:31	3,229
Canada BE limits Canada BE limits	Naveen Kumar	2013-09-23 14:35	1	2013-09-23 13:08	4,355
BE study for Tablet vs Sachet BE study for Tablet vs Sachet	sparsh	2013-09-21 11:24	1	2013-09-22 14:53	2,735
clinical trials/ BE studies for locally acting drugs clinical trials/ BE studies for locally acting drugs clinical trials/ BE studies for locally acting drugs clinical trials/ BE studies for locally acting drugs clinical trials/ BE studies for locally acting drugs clinical trials/ BE studies for locally acting drugs	jagankm	2012-01-25 11:26	5	2013-09-19 07:45	7,231
biobatch size and scale up Type II Variation Type II Variation Type II Variation Type II Variation Type II Variation	Elena	2013-09-17 10:06	5	2013-09-18 10:55	7,207
Blank Plasma	sparsh	2013-09-18 10:19	0		1,613
Draft EMA MR formulations GL published! Housekeeping suggestions Scaling for pAUCs Draft EMA MR formulations GL published! Topicals → 1995 NfG Topicals, generic Topicals, generic Topicals, generic Clarity on waiving multiple dose study Hey, it is just a draft! Critical review of García-Arieta et al. (2012) SD vs. MD, partial AUCs SD vs. MD, partial AUCs SD vs. MD, partial AUCs SD vs. MD, partial AUCs pAUCs, alternative metrics, alcohol tmax (DR & multiphasic) Presentations of the EUFEPS meeting ⧫ Deadline approaching ⧫ Download comment form Food effect Food effect Variability (MR vs. IR)	Ohlbe	2013-03-15 12:10	22	2013-09-12 13:23	34,537
Development Safety Update Report requirement	Tina	2013-09-12 14:20	0		1,701
Sample size Sample size Sample size Overpowering Overpowering Overpowering Overpowering Overpowering Overpowering Conservative study planning Conservative study planning Conservative study planning confidence limit of the CV CL of CV CL of CV CL of CV PE consideration PE consideration PE consideration PE consideration Sockpuppet? PE consideration	vasup	2013-07-29 08:37	21	2013-09-12 11:04	10,185
Waiving of md study in MR combination product Still a draft!	Dr_Dan	2013-09-11 14:42	1	2013-09-11 12:51	2,295
Fluticasone/Salmeterol FDA guidance Fluticasone/Salmeterol FDA guidance	ElMaestro	2013-09-10 16:54	1	2013-09-11 10:13	2,499
Nicergoline Nicergoline Nicergoline	ioanam	2013-09-07 21:55	2	2013-09-10 12:42	4,144
Bioequivalence study of Sulfasalazine for Chile	manojskr	2013-09-09 15:10	0		2,172
Europe/USA/Canada Homework	alagu	2013-09-07 11:34	1	2013-09-07 12:25	2,725