Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Wow!	Helmut	2013-04-16 15:58	0		3,180
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	9,899
FDA and MENA (Q&A)	Helmut	2013-08-23 11:38	0		7,027
Propaganda	Helmut	2013-11-30 19:22	0		3,300
EMA: Draft product-specific guidance ♬	Helmut	2013-12-06 01:54	0		5,301
EMA/USFDA: Inspections of BE studies	Helmut	2013-12-25 17:28	0		3,358
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	9,333
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	7,606
Regulatory harmonization? Harmonization or harmonisation ?	Helmut	2014-02-28 14:43	1	2014-02-28 22:58	5,695
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	7,471
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	16,768
EMA: 5 Product-specific guidances adopted	Helmut	2014-12-20 02:05	0		4,519
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	22,980
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	7,908
Canada HVDS update Canada HVDS update at best half baked	vish14184	2016-04-20 19:22	2	2016-04-20 22:43	7,092