Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
ICH E8(R1) step 2b ICH E8(R1) step 2b ICH E8(R1) step 2b	Helmut	2019-06-03 10:02	2	2019-06-04 04:03	370
FDA Web page Redesign of the FDA’s site: A rant ☠	Rosy	2019-05-03 16:28	1	2019-05-03 17:28	709
WHO Questions and Answers: similar biotherapeutic products	Helmut	2019-04-15 00:25	0		329
Pharmacokinetic Solidarity? Pharmacokinetic Solidarity? Pharmacokinetic Solidarity? Pharmacokinetic Solidarity?	mittyri	2019-04-02 12:32	3	2019-04-02 13:37	543
News from EMA: Pharmacokinetic Solidarity	EMA.Press.Office	2019-04-01 00:07	0		612
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 09:57	559
Outliers: The FDA follows the EMA Outliers: The FDA follows the EMA	Helmut	2019-03-05 01:24	1	2019-03-06 19:23	739
All animals are equal, but some animals are more equal than others	Helmut	2018-10-09 14:33	0		715
Redesign of the EMA’s website	Helmut	2018-10-08 12:20	0		693
FDA: Dissolution Testing and Acceptance Criteria for IR…	Helmut	2018-09-03 14:46	0		537
FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA	Helmut	2018-08-09 10:52	0		714
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	8,690
EMA: 2 product-specific guidances adopted EMA: New product-specific draft guidances published EMA: New product-specific draft guidance published EMA: 5 product-specific guidances adopted	Helmut	2018-06-26 14:40	3	2018-08-03 16:52	2,475
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	4,371
ICH M9 Draft	Helmut	2018-07-16 14:49	0		805