Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		147,674
Winnonlin issues Winnonlin issues Winnonlin issues	Software	jag009	2021-09-15 18:34	2	2021-09-15 19:21	98
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	183
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	864
RLD identification in EU region in view of Brexit RLD identification in EU region in view of Brexit 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	4	2021-09-10 20:22	483
Suitability in bioanalysis Suitability in bioanalysis	Bioanalytics	selwa ts	2021-09-09 19:44	1	2021-09-09 23:09	157
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	1,652
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	528
Desperate reader Desperate reader Misunderstanding? Misunderstanding? Here we are	General Statistics	Helmut	2021-08-27 15:51	4	2021-08-28 10:38	642
Clarity required Follow the guidance	Regulatives / Guidelines	suchit_bhavsar	2021-08-27 05:02	1	2021-08-27 10:31	422
Phoenix Template v1.5 for the EMA’s ABEL Phoenix Template v1.5 for the EMA’s ABEL Phoenix Template v1.5 for the EMA’s ABEL FDA’s RSABE RSABE: Examples	Software	Helmut	2017-08-23 19:45	4	2021-08-24 15:54	4,151
What is most common reason of failure of BE study? My observations… My observations… Inveterate optimists… My observations… What is most common reason of failure of BE study? What is most common reason of failure of BE study? The Man in the Armani suit Management…	Study Assessment	akif	2021-08-24 09:42	8	2021-08-24 15:47	680
Significant difference in Cmax of Reference drug product Significant difference in Cmax of Reference drug product Significant difference in Cmax of Reference drug product Different products → different BA Significant difference in Cmax of Reference drug product Reasons? Reasons?	Study Assessment	Mehul Patel	2021-08-17 10:00	6	2021-08-24 12:06	596
Biowaiver and PK linearity - EU	Study Assessment	Susanh	2021-08-18 16:38	0		312
Biowaiver for lower strength Biowaiver for lower strength Biowaiver for lower strength Biowaiver for lower strength	Study Performance	Vishal S	2021-08-06 11:12	3	2021-08-18 10:34	1,487