Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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	19,749
EMA: draft GLs (MR & transdermal patches – quality)	Helmut	2012-09-15 14:52	0		4,786
REMS: A bitter pill?	luvblooms	2012-08-27 07:19	0		4,355
FDA: GDUFA / D-U-N-S Number	Helmut	2012-08-23 17:57	0		4,682
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	31,791
White papers on bioequivalence studies	ramesh_7779	2011-03-28 07:11	0		5,215
EMA: Questions & Answers Acceptance ranges	Helmut	2010-08-03 16:38	1	2010-08-03 15:03	10,796
EMA: Concept paper on revision of MR NfG	Helmut	2010-06-08 16:58	0		5,463
Clinical Trials in India	Helmut	2009-12-31 14:56	0		5,536
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	14,113
EU: Recommendation for Revison of NfG	Helmut	2007-06-17 17:16	0		5,805
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	11,077
Generic Dimenhydrinate Injection USP for Motion Sickness	Helmut	2004-08-26 16:29	0		16,179