Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
where can I find Old FDA PSG where can I find Old FDA PSG	Achievwin	2023-03-24 14:51	1	2023-03-25 17:03	47
UK/EU IMP Labelling requirement for Comporator used in BE studies UK/EU IMP Labelling requirement for Comporator used in BE studies	HallaGulla	2023-03-22 12:34	1	2023-03-24 13:59	115
In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission In vitro binding study for sevelamer carbonate for Europe submission	jansari	2023-02-21 17:28	6	2023-03-01 15:34	912
Biowaiver for site transfer in Mexico Biowaiver for site transfer in Mexico	jag009	2023-01-17 14:57	1	2023-02-08 01:59	546
IMP retention quantity requirement for Japan market	Rahul Metangale	2023-01-23 11:31	0		430
M10 Q&A dated 16 Jan 2023	ElMaestro	2023-01-20 09:32	0		580
FDA's HVD SAS Code / Standard Error / CV FDA's HVD SAS Code / Standard Error / CV FDA's HVD SAS Code / Standard Error / CV CV limbo CV limbo CV limbo CV limbo CV limbo CV limbo	j_kevin	2022-12-08 09:41	8	2023-01-04 11:39	1,714
Chili guidelines ANAMED	gsrao2022	2022-12-25 16:17	1	2022-12-27 09:42	904
Frequent Queries from FDA: Gender Imbalance Frequent Queries from FDA: Gender Imbalance Frequent Queries from FDA: Gender Imbalance Frequent Queries from FDA: Gender Imbalance	krish85	2022-11-14 04:06	3	2022-11-22 07:02	1,345
US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE? US (or EU) ANDA: Fail f2 but pass BE?	jag009	2022-09-01 22:16	12	2022-09-20 14:02	2,238
strange question: An RLD (RS) which can be scored strange question: An RLD (RS) which can be scored strange question: An RLD (RS) which can be scored	jag009	2022-09-08 19:30	2	2022-09-14 15:25	1,122
T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5% T/R potency <5%	Achievwin	2022-09-07 18:22	8	2022-09-09 15:42	1,612
Application of 90% CI for Ctau Do your homework first	Mithu	2022-09-01 06:55	1	2022-09-01 14:40	998
Why was TRT (treatment) included in Random effect of PROC Mixed?	neilfiona	2022-09-01 11:58	0		784
Biowaiver criteria - 5% Biowaiver criterion <5% (not ≤5%) Biowaiver criterion <5% (not ≤5%) Biowaiver criterion <5% (not ≤5%)	Laura Carreiras	2022-08-12 12:03	3	2022-08-16 16:22	1,140