Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Bioequivalence in prime time TV news Bioequivalence in prime time TV news Bioequivalence in prime time TV news Bioequivalence in prime time TV news Bioequivalence in prime time TV news Bioequivalence in prime time TV news If you know German… If you know German… Monitoring CROs Monitoring CROs Ethics? Ethics? Monitoring CROs Monitoring CROs Monitoring CROs Inspectors ≠ teachers (rather = examiners) RCA Speculations Speculations Speculations	Dr_Dan	2014-12-05 08:42	19	2015-01-23 16:08	28,257
EMA: 5 Product-specific guidances adopted	Helmut	2014-12-20 02:05	0		5,337
Article: BE-criteria too strict sometimes? Article: BE-criteria too strict sometimes? Risk assessment Risk assessment Risk assessment Risk assessment Risk assessment Are all men born equal? Article: BE-criteria too strict sometimes? Some animals are more equal than others Some animals are more equal than others Some animals are more equal than others Some animals are more equal than others Some animals are more equal than others Some animals are more equal than others	Helmut	2014-09-23 12:39	14	2014-10-15 01:20	21,158
EMA: GL on quality of oral MR products EMA: GL on quality of oral MR products EMA: GL on quality of oral MR products EMA: GL on quality of oral MR products	Helmut	2014-07-31 18:06	3	2014-08-10 14:02	9,441
Regulatory harmonization? Harmonization or harmonisation ?	Helmut	2014-02-28 14:43	1	2014-02-28 22:58	7,267
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	9,633
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	11,732
EMA/USFDA: Inspections of BE studies	Helmut	2013-12-25 17:28	0		4,148
EMA: Draft product-specific guidance ♬	Helmut	2013-12-06 01:54	0		6,374
Propaganda	Helmut	2013-11-30 19:22	0		4,037
FDA and MENA (Q&A)	Helmut	2013-08-23 11:38	0		8,191
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	12,056
Wow!	Helmut	2013-04-16 15:58	0		4,003
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	13,488
FDA: new guidances expected in 2013 FDA: new guidances expected in 2013	Helmut	2013-02-12 15:24	1	2013-02-13 14:44	8,621