Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
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 15:33	850
SUPAC level 3 changes for MR formulations	Mithu	2019-09-30 07:42	0		167
12 units from 12 different bottles should be used - Dissolution for Suspensions	bharathi	2019-09-26 12:20	0		772
steady state for modified release steady state for modified release	Kelen	2019-09-20 20:04	1	2019-09-23 10:04	488
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 07:57	6,281
Reference replicated designs	rajasekharkakarla	2019-09-20 06:35	0		303
BA/BE for guidelines for ANVISA in English version ANVISA	Pandu	2019-09-10 05:30	1	2019-09-10 11:25	516
IS response variations IS response variations	Ohlbe	2019-09-04 19:03	1	2019-09-06 16:21	522
China Local BE study waiver China BE study China BE study	Ajit Thorat	2019-08-29 09:26	2	2019-09-04 15:15	677
Proportional or non proportional products	Mithu	2019-08-27 07:18	0		325
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 16:40	548
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 12:05	563
Reference Literature Do your homework first	Neil	2019-07-25 18:18	1	2019-07-26 10:42	477
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 14:18	762
IVRT or IVPT BE studies	jag009	2019-07-22 22:59	0		337