Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Good bye! Fare well, Canary Wharf! And nevermore. Good bye! Fare well, Canary Wharf! And nevermore. Brexit	Helmut	2019-03-11 23:40	2	2019-03-12 08:57	4,617
Outliers: The FDA follows the EMA Outliers: The FDA follows the EMA	Helmut	2019-03-05 01:24	1	2019-03-06 18:23	4,942
All animals are equal, but some animals are more equal than others	Helmut	2018-10-09 14:33	0		2,886
Redesign of the EMA’s website	Helmut	2018-10-08 12:20	0		3,668
FDA: Dissolution Testing and Acceptance Criteria for IR…	Helmut	2018-09-03 14:46	0		3,424
FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA	Helmut	2018-08-09 10:52	0		2,819
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 12:42	14,889
EMA: 2 product-specific guidances adopted EMA: New product-specific draft guidances published EMA: New product-specific draft guidance published EMA: 5 product-specific guidances adopted	Helmut	2018-06-26 14:40	3	2018-08-03 14:52	7,109
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 20:59	10,791
ICH M9 Draft	Helmut	2018-07-16 14:49	0		2,741
Updated TPD BE guidances Updated TPD BE guidances Canada-Comparative bioavaiability standards	BRB	2018-06-18 22:53	2	2018-06-27 10:36	5,319
New EMA guideline: Handling and shipping of IMPs	Helmut	2018-05-24 15:45	0		2,799
Shenanigans	ElMaestro	2018-04-15 14:50	0		2,361
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	7,377
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	22,835