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		16,105
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	10,941
EU: Recommendation for Revison of NfG	Helmut	2007-06-17 17:16	0		5,773
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	14,032
Clinical Trials in India	Helmut	2009-12-31 14:56	0		5,483
EMA: Concept paper on revision of MR NfG	Helmut	2010-06-08 16:58	0		5,399
EMA: Questions & Answers Acceptance ranges	Helmut	2010-08-03 16:38	1	2010-08-03 15:03	10,741
White papers on bioequivalence studies	ramesh_7779	2011-03-28 07:11	0		5,164
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	31,544
FDA: GDUFA / D-U-N-S Number	Helmut	2012-08-23 17:57	0		4,647
REMS: A bitter pill?	luvblooms	2012-08-27 07:19	0		4,322
EMA: draft GLs (MR & transdermal patches – quality)	Helmut	2012-09-15 14:52	0		4,742
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	19,601
FDA: new guidances expected in 2013 FDA: new guidances expected in 2013	Helmut	2013-02-12 15:24	1	2013-02-13 14:44	8,605
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	13,462