Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		148,220
Ibuprofen product-specific bioequivalence guidance EMA	Regulatives / Guidelines	qualityassurance	2021-09-26 07:45	0		52
dropouts in replicate studies dropouts in replicate studies The EMA’s Data set I is incomplete The EMA’s Data set I is incomplete	Regulatives / Guidelines	Loky do	2021-09-23 14:54	3	2021-09-25 22:01	221
Sevelamer Carbonate In vitro binding study for EMA submission	Regulatives / Guidelines	jansari	2021-09-24 19:03	0		93
EU: Fed or fasting conditions for BE study EU: Fed state according to the reference’s SmPC	Design Issues	Farmacevt	2021-09-24 15:47	1	2021-09-24 16:07	98
RLD identification in EU region in view of Brexit RLD identification in EU region in view of Brexit MHRA: No ‘own’ BE GL? RLD identification in EU region in view of Brexit RLD identification in EU region in view of Brexit No ‘RLD’ in the EEA	Regulatives / Guidelines	shahajan baig	2021-08-31 14:49	5	2021-09-24 15:36	611
Another two... Another two... Dates Some more info Cheating Increased variability Increased variability Visualization Another two...	GxP / QC / QA	Ohlbe	2021-09-16 23:41	8	2021-09-19 09:18	683
Desperate reader Desperate reader Misunderstanding? Misunderstanding? Here we are Papers FDA: PROC MIXED (‼) for ABE FDA: PROC MIXED (‼) for ABE FDA: PROC MIXED (‼) for ABE	Regulatives / Guidelines	Helmut	2021-08-27 15:51	8	2021-09-17 17:11	916
Winnonlin issues Winnonlin issues Winnonlin issues	Software	jag009	2021-09-15 18:34	2	2021-09-15 19:21	234
Need help downloading a publication Old references… Old references… Old references…	Power / Sample Size	selwa ts	2021-09-13 15:25	3	2021-09-14 17:46	292
FDA guideline on BE, draft August 2021 FDA guideline on BE, draft August 2021 FDA guideline on BE, draft August 2021 Bias correction unveiled FDA guideline on BE, draft August 2021 FDA guideline on BE, draft August 2021	BE/BA News	ElMaestro	2021-08-23 14:42	5	2021-09-10 20:47	1,056
Suitability in bioanalysis Suitability in bioanalysis	Bioanalytics	selwa ts	2021-09-09 19:44	1	2021-09-09 23:09	237
FARTSSIE v2.5 FARTSSIE v2.7 FARTSSIE v2.7 FARTSSIE v2.7 FARTSSIE v2.7 FARTSSIE v2.7 Richard Moisan FARTSSIE 2.8	Software	Helmut	2020-10-18 11:09	7	2021-09-09 15:08	1,696
Application of AI/Machine learning for BA/BE studies Suffering from Human Unintelligence Suffering from Human Unintelligence Application of AI/Machine learning for BA/BE studies	Design Issues	Achievwin	2021-08-17 19:31	3	2021-09-02 20:23	606
Clarity required Follow the guidance	Regulatives / Guidelines	suchit_bhavsar	2021-08-27 05:02	1	2021-08-27 10:31	506