Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Wow!	Helmut	2013-04-16 15:58	0		2,646
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	8,492
FDA and MENA (Q&A)	Helmut	2013-08-23 11:38	0		6,228
Propaganda	Helmut	2013-11-30 19:22	0		2,728
EMA: Draft product-specific guidance ♬	Helmut	2013-12-06 01:54	0		4,528
EMA/USFDA: Inspections of BE studies	Helmut	2013-12-25 17:28	0		2,680
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	7,777
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	6,314
Regulatory harmonization? Harmonization or harmonisation ?	Helmut	2014-02-28 14:43	1	2014-02-28 22:58	4,521
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	6,353
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	14,825
EMA: 5 Product-specific guidances adopted	Helmut	2014-12-20 02:05	0		3,843
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	20,566
ANMAT – Bioquivalence requirements under consultation ANMAT – Bioquivalence requirements under consultation ANMAT – Bioquivalence requirements under consultation History	cbertoncini	2016-04-12 14:17	3	2016-04-14 12:41	6,415
Canada HVDS update Canada HVDS update at best half baked	vish14184	2016-04-20 19:22	2	2016-04-20 22:43	5,798