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		13,788
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	7,734
EU: Recommendation for Revison of NfG	Helmut	2007-06-17 17:16	0		4,405
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	10,409
Clinical Trials in India	Helmut	2009-12-31 14:56	0		4,002
EMA: Concept paper on revision of MR NfG	Helmut	2010-06-08 16:58	0		4,106
EMA: Questions & Answers Acceptance ranges	Helmut	2010-08-03 16:38	1	2010-08-03 15:03	8,214
White papers on bioequivalence studies	ramesh_7779	2011-03-28 07:11	0		3,738
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	23,773
FDA: GDUFA / D-U-N-S Number	Helmut	2012-08-23 17:57	0		3,397
REMS: A bitter pill?	luvblooms	2012-08-27 07:19	0		3,007
EMA: draft GLs (MR & transdermal patches – quality)	Helmut	2012-09-15 14:52	0		3,148
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	15,109
FDA: new guidances expected in 2013 FDA: new guidances expected in 2013	Helmut	2013-02-12 15:24	1	2013-02-13 14:44	6,015
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	9,489