Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Brexit Brexit	Helmut	2017-12-12 12:50	1	2018-01-10 10:56	5,914
Levothyroxine: A black swan? Levothyroxine: A black swan? Levothyroxine: A black swan? Were physicians/patients aware of the change in the formulation? Were physicians/patients aware of the change in the formulation? Were physicians/patients aware of the change in the formulation? Levothyroxine: A black swan? Levothyroxine: A black swan? Levothyroxine: A black swan?	Helmut	2017-11-26 12:51	8	2017-11-28 07:53	17,874
Whistleblowers, stand up! Whistleblowers, stand up! Whistleblowers, stand up! This isn't about whistleblowers This isn't about whistleblowers This isn't about whistleblowers	Helmut	2017-05-23 14:12	5	2017-05-25 10:37	6,608
Interesting Article WHO: healthy volunteers should be healthy...	Helmut	2017-03-19 15:45	1	2017-03-23 09:47	4,080
Latest EMA drafts on indidividual compounds	nobody	2017-01-03 12:31	0		2,752
EMA: 7 product-specific guidances adopted EMA: 7 product-specific guidances adopted capecitabine ≠ NTID; reference-scaling Tadalafil: Similar technology and formulas as the originator Tadalafil: Similar technology and formulas as the originator 9 new just published Five new drafts published New product specific guidance of Fidaxomicin EMA: 7 product-specific guidances adopted (Capecitabine) Capecitabine: study with healthy volunteers	Helmut	2015-07-07 14:10	9	2016-12-14 11:39	18,598
1,000+ Chinese NDAs rejected due to fabricated or incomplete clinical data It's all about the money It's all about the money	Helmut	2016-09-28 20:55	2	2016-09-30 20:58	7,355
Reflection paper on the dissolution spec’s for generic oral IR products	Helmut	2016-05-15 18:28	0		3,514
Product specific guidance EMA Product specific guidance EMA	Mahesh M	2015-10-07 09:51	1	2016-05-02 22:29	7,827
Canada HVDS update Canada HVDS update at best half baked	vish14184	2016-04-20 19:22	2	2016-04-20 22:43	7,103
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	7,920
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	23,019
EMA: 5 Product-specific guidances adopted	Helmut	2014-12-20 02:05	0		4,523
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	16,802
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	7,483