Bioequivalence and Bioavailability Forum

Subject	Author	posted	R’s	last reply	V’s
Shenanigans	ElMaestro	2018-04-15 14:50	0		247
Revision of the BE-GL? ...and much more Postponed: New target date Q4 2018 Postboned: New target date Q4 2018 Postponed: New target date Q4 2018	Helmut	2017-04-29 15:26	4	2018-02-15 13:32	1,911
Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud One more One more Fraud Kill the messenger Kill the messenger Kill the messenger Kill the messenger	Helmut	2016-04-24 13:14	18	2018-02-15 01:28	9,037
Brexit Brexit	Helmut	2017-12-12 12:50	1	2018-01-10 11:56	808
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 08:53	8,019
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	1,876
Interesting Article WHO: healthy volunteers should be healthy...	Helmut	2017-03-19 15:45	1	2017-03-23 10:47	1,315
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	19,005
Latest EMA drafts on indidividual compounds	nobody	2017-01-03 12:31	0		1,094
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	9,260
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	2,925
Reflection paper on the dissolution spec’s for generic oral IR products	Helmut	2016-05-15 18:28	0		1,596
Product specific guidance EMA Product specific guidance EMA	Mahesh M	2015-10-07 09:51	1	2016-05-03 00:29	4,293
Canada HVDS update Canada HVDS update at best half baked	vish14184	2016-04-20 19:22	2	2016-04-21 00:43	3,509
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	3,168
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	10,440