Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Generic Dimenhydrinate Injection USP for Motion Sickness	Helmut	2004-08-26 16:29	0		14,213
FDA: ACPSCP Meeting (HVDs, NTI Drugs) FDA: ACPSCP Meeting (HVDs, NTI Drugs) FDA: ACPSCP Meeting cancelled	Helmut	2007-03-21 13:56	2	2007-04-06 14:49	8,257
EU: Recommendation for Revison of NfG	Helmut	2007-06-17 17:16	0		4,639
Concept Paper for Addendum to EU NfG: HVDs Concept Paper for Addendum to EU NfG: HVDs HVDs covered by the new EU NfG	Helmut	2006-05-25 13:33	2	2007-11-02 18:57	10,963
Clinical Trials in India	Helmut	2009-12-31 14:56	0		4,266
EMA: Concept paper on revision of MR NfG	Helmut	2010-06-08 16:58	0		4,334
EMA: Questions & Answers Acceptance ranges	Helmut	2010-08-03 16:38	1	2010-08-03 15:03	8,605
White papers on bioequivalence studies	ramesh_7779	2011-03-28 07:11	0		3,976
EMA: Q&A on biphasic MR products EMA: Q&A on biphasic MR products EMA: Q&A on biphasic MR products EMA: Q&A on biphasic MR products EMA vs. FDA MPH examples MPH examples MPH examples FDA more straight? and what about power? and what about power? and what about power? FDA more straight? FDA more straight? Multiphasic MR ≠ DR Multiphasic MR ≠ DR Metadate CD (30/70)	Helmut	2012-03-06 15:23	16	2012-03-28 13:45	24,563
FDA: GDUFA / D-U-N-S Number	Helmut	2012-08-23 17:57	0		3,564
REMS: A bitter pill?	luvblooms	2012-08-27 07:19	0		3,175
EMA: draft GLs (MR & transdermal patches – quality)	Helmut	2012-09-15 14:52	0		3,332
Bupropion ER Tablets Bupropion ER Tablets results, wording Null hypothesis, PowerTOST/sampleN.inf() Null hypothesis, PowerTOST/sampleN.inf() power.inf() power.inf() power.inf() power.inf()	Helmut	2012-10-05 15:59	8	2012-10-09 17:51	15,659
FDA: new guidances expected in 2013 FDA: new guidances expected in 2013	Helmut	2013-02-12 15:24	1	2013-02-13 14:44	6,381
EMA: Q&A update (Two-Stage designs) EMA: Q&A update (Two-Stage designs) EMA: Q&A update (Two-Stage designs) Almighty miraculous oracle Miraculouser oracle	Helmut	2013-03-08 14:47	4	2013-03-12 11:12	9,997