Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last Reply	Views
FDA: Dissolution Testing and Acceptance Criteria for IR…	Helmut	2018-09-03 14:46	0		167
FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA	Helmut	2018-08-09 10:52	0		329
EMA: Q&A Update EMA: Q&A Update The early bird gets the worm The early bird gets the worm but Lambda Therapeutic Ltd.? Lambda Therapeutic Ltd.? EMA: Q&A Update; Expected studies for Quetiapine PR Tablets	Helmut	2013-11-15 13:53	6	2018-08-06 14:42	7,060
EMA: 2 product-specific guidances adopted EMA: New product-specific draft guidances published EMA: New product-specific draft guidance published EMA: 5 product-specific guidances adopted	Helmut	2018-06-26 14:40	3	2018-08-03 16:52	1,282
New FDA BMV guideline What a monster! What a monster! Two Versions: May 21 & May 24 Repeats as part of investigations, ja oder nein? Repeats as part of investigations, ja oder nein? Two Versions: May 21 & May 24 Requirements ⇒ recommendations Requirements ⇒ recommendations	Ohlbe	2018-05-21 16:28	8	2018-08-02 22:59	1,722
ICH M9 Draft	Helmut	2018-07-16 14:49	0		405
Updated TPD BE guidances Updated TPD BE guidances Canada-Comparative bioavaiability standards	BRB	2018-06-18 22:53	2	2018-06-27 12:36	701
New EMA guideline: Handling and shipping of IMPs	Helmut	2018-05-24 15:45	0		653
Shenanigans	ElMaestro	2018-04-15 14:50	0		511
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	2,451
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	11,109
Brexit Brexit	Helmut	2017-12-12 12:50	1	2018-01-10 11:56	1,499
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	9,603
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	2,436
Interesting Article WHO: healthy volunteers should be healthy...	Helmut	2017-03-19 15:45	1	2017-03-23 10:47	1,565
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	22,267

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