Bioequivalence and Bioavailability Forum

Subject	Author	posted	R’s	last reply	V’s
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 12:37	927
Revision of the BE-GL? ...and much more	Helmut	2017-04-29 15:26	1	2017-04-29 15:58	656
Interesting Article WHO: healthy volunteers should be healthy...	Helmut	2017-03-19 15:45	1	2017-03-23 10:47	899
EMA BE-GL: Clarifications / Corrections? Good news!? Good news!? Update Q&A published 14 March 2011 Q&A published 14 March 2011 Phoenix/WinNonlin 6.1.0.173 ANOVA party prevails THX! Outlier Outliers - yes, but how? Questions and Ambiguities Residuals and Outliers in Replicate Design Crossover Studies Info requested Confused as well... Q&A published 14 March 2011 SAS code: Warning Copy & paste Subtleties, flaws, questions Subtleties, flaws, questions Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model	Helmut	2010-06-22 18:53	24	2017-03-18 21:59	14,882
Latest EMA drafts on indidividual compounds	nobody	2017-01-03 12:31	0		766
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 12:39	7,253
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 22:58	1,952
Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud One more One more Fraud	Helmut	2016-04-24 13:14	14	2016-07-22 15:06	5,822
Reflection paper on the dissolution spec’s for generic oral IR products	Helmut	2016-05-15 18:28	0		1,247
Product specific guidance EMA Product specific guidance EMA	Mahesh M	2015-10-07 09:51	1	2016-05-03 00:29	3,517
Canada HVDS update Canada HVDS update at best half baked	vish14184	2016-04-20 19:22	2	2016-04-21 00:43	2,880
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 14:41	2,250
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 17:08	7,212
EMA: 5 Product-specific guidances adopted	Helmut	2014-12-20 02:05	0		2,039
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 03:20	6,504
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 16:02	3,620