Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Regulatory harmonization? Harmonization or harmonisation ?	Helmut	2014-02-28 14:43	1	2014-02-28 22:58	5,708
BA/BE centers to be approved by CDSCO – India BA/BE centers to be approved by CDSCO – India BA/BE centers to be approved by CDSCO – India BA/BE centers to be approved by CDSCO – India BA/BE centers to be approved by CDSCO – India	Geokad	2014-02-18 21:06	4	2014-02-26 12:41	7,620
ANDA Submissions-RTR (Refuse to Receive) Failed studies, alternate designs Failed studies, alternate designs Jan 2nd, 2014?	kvgreddy06	2013-12-26 08:15	3	2014-01-02 17:54	9,347
EMA/USFDA: Inspections of BE studies	Helmut	2013-12-25 17:28	0		3,364
EMA: Draft product-specific guidance ♬	Helmut	2013-12-06 01:54	0		5,306
Propaganda	Helmut	2013-11-30 19:22	0		3,305
FDA and MENA (Q&A)	Helmut	2013-08-23 11:38	0		7,033
EMA: Concept paper on product-specific BE guidances If required?? Guidance vs. Guideline Guidance vs. Guideline Guidance vs. Guideline Guidance vs. Guideline	Helmut	2013-08-06 13:51	5	2013-08-20 10:54	9,910
Wow!	Helmut	2013-04-16 15:58	0		3,184
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	10,769
FDA: new guidances expected in 2013 FDA: new guidances expected in 2013	Helmut	2013-02-12 15:24	1	2013-02-13 14:44	7,061
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	16,410
EMA: draft GLs (MR & transdermal patches – quality)	Helmut	2012-09-15 14:52	0		3,598
REMS: A bitter pill?	luvblooms	2012-08-27 07:19	0		3,421
FDA: GDUFA / D-U-N-S Number	Helmut	2012-08-23 17:57	0		3,856