Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
IMP retention quantity requirement for Japan market	Rahul Metangale	2023-01-23 11:31	0		2,457
M10 Q&A dated 16 Jan 2023	ElMaestro	2023-01-20 09:32	0		2,780
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 12:39	6,921
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	4,229
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	5,874
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	3,394
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	5,129
Application of 90% CI for Ctau Do your homework first	Mithu	2022-09-01 06:55	1	2022-09-01 14:40	3,117
Why was TRT (treatment) included in Random effect of PROC Mixed?	neilfiona	2022-09-01 11:58	0		2,335
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	4,433
Partial AUC H[a]VD and MDT Plateau Time in Kazakhstan? Plateau Time in Kazakhstan? EEU changes came into force 11.03.2021	Vaibhav Patil	2022-07-29 07:20	4	2022-08-01 19:24	4,482
no gender differences doxylamine gender differences doxycycline gender differences doxycycline ≠ dicycloverine = dicyclomine ≠ doxylamine doxycycline ≠ dicycloverine = dicyclomine ≠ doxylamine	deepakpangavhane	2022-07-30 08:55	4	2022-08-01 08:44	3,741
BE NOC fee for Gliclazide 60 mg MR Tablet BE NOC fee for Gliclazide 60 mg MR Tablet	Tricky TAB	2022-07-03 08:21	1	2022-07-28 10:49	2,753
schedule time vs. actual time for ANVISA BE schedule time for ANVISA? schedule time vs. actual time for ANVISA BE Not even wrong Not even wrong ANVISA: MD studies no more required Relatorio estatistico Relatorio estatistico ANVISA ANVISA Relatorio estatistico Full book? schedule time vs. actual time for ANVISA BE schedule time vs. actual time for ANVISA BE TPD? TPD? TPD! schedule time vs. actual time for ANVISA BE schedule time vs. actual time for ANVISA BE	Shuanghe	2022-07-10 00:36	18	2022-07-25 10:32	6,323
Drug-Drug Interaction procedure -between inhalation and oral Tab Relax & cool down?	Mr.Rao	2022-07-15 08:47	1	2022-07-15 07:54	2,876