Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Product specific guidance EMA Product specific guidance EMA	Mahesh M	2015-10-07 09:51	1	2016-05-02 22:29	9,238
Reflection paper on the dissolution spec’s for generic oral IR products	Helmut	2016-05-15 18:28	0		4,297
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	8,747
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	21,240
Latest EMA drafts on indidividual compounds	nobody	2017-01-03 12:31	0		3,531
Interesting Article WHO: healthy volunteers should be healthy...	Helmut	2017-03-19 15:45	1	2017-03-23 09:47	5,308
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	8,606
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	20,593
Brexit Brexit	Helmut	2017-12-12 12:50	1	2018-01-10 10:56	7,618
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 00:28	26,776
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 12:32	9,126
Shenanigans	ElMaestro	2018-04-15 14:50	0		3,238
New EMA guideline: Handling and shipping of IMPs	Helmut	2018-05-24 15:45	0		3,551
Updated TPD BE guidances Updated TPD BE guidances Canada-Comparative bioavaiability standards	BRB	2018-06-18 22:53	2	2018-06-27 10:36	6,924
ICH M9 Draft	Helmut	2018-07-16 14:49	0		3,529