Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
SUPAC level 3 changes for MR formulations SUPAC level 3 changes for MR formulations SUPAC level 3 changes for MR formulations SUPAC level 3 changes for MR formulations	Mithu	2019-09-30 07:42	3	2019-10-24 03:34	5,614
12 units from 12 different bottles should be used - Dissolution for Suspensions 12 units from 12 different bottles should be used - Dissolution for Suspensions	bharathi	2019-09-26 12:20	1	2019-10-22 19:29	5,004
Ezetimibe BE Ezetimibe BE Confusing guidance Confusing guidance Ezetimibe final guidance Ezetimibe final guidance Ezetimibe final guidance Ezetimibe BE Ezetimibe BE	Mutasim	2019-09-23 14:40	8	2019-09-30 13:33	9,157
0 hr Pre-dose concentration but less than 5% of Cmax 0 hr Pre-dose concentration but less than 5% of Cmax 0 hr Pre-dose concentration but less than 5% of Cmax Reanalysis if possible Reanalysis if possible >6 sources of matrix >6 sources of matrix >6 sources of matrix >6 sources of matrix Flashback Flashback No correction if ≤5% Cmax No correction if ≤5% Cmax excluded period(s) excluded period(s)	jag009	2012-03-29 19:34	14	2019-09-20 05:57	14,481
Reference replicated designs	rajasekharkakarla	2019-09-20 06:35	0		2,904
BA/BE for guidelines for ANVISA in English version ANVISA	Pandu	2019-09-10 05:30	1	2019-09-10 09:25	4,574
China Local BE study waiver China BE study China BE study	Ajit Thorat	2019-08-29 09:26	2	2019-09-04 13:15	6,307
Proportional or non proportional products	Mithu	2019-08-27 07:18	0		2,232
Outlier test for reference replicate crossover study design Outlier test for reference replicate crossover study design Murky waters	abhimanyu	2019-08-13 15:11	2	2019-08-13 14:40	4,564
Sponsor’s Medical Expert in Bioequivalence Study What’s a “Sponsor’s Medical Expert”?	yatish gosai	2019-08-06 14:29	1	2019-08-07 10:05	4,261
Reference Literature Do your homework first	Neil	2019-07-25 18:18	1	2019-07-26 08:42	4,102
One fail and one success, should it be accepted? One fail and one success, should it be accepted? One fail and one success, should it be accepted? One fail and one success, should it be accepted?	ssussu	2019-07-17 11:45	3	2019-07-23 12:18	5,096
IVRT or IVPT BE studies	jag009	2019-07-22 22:59	0		2,554
FDA: Date when a product is designated as RS (or RLD) FDA: Date when a product is designated as RS (or RLD) OB Annual edition, Current Cumulative Supplement OB Annual edition, Current Cumulative Supplement	jag009	2019-07-18 19:11	3	2019-07-22 02:16	5,617
Baseline sampling Dihydroergotamine Nasal Spray Dihydroergotamine Nasal Spray Baseline sampling	NK	2019-06-26 07:25	3	2019-06-26 10:47	5,223