Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
IS response variations IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations Not more on IS response variations Not more on IS response variations the run passes = there is no problem? the run passes = there is no problem?	Ohlbe	2019-09-04 19:03	14	2019-11-13 19:17	772
Generic submission in India	jag009	2019-11-11 21:43	0		83
Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet	Nidhiya J S	2019-11-05 06:14	4	2019-11-11 10:51	229
Clarification from Russian expert organization regarding telmisartan BE studies Clarification from Russian expert organization… Questions Guesses & answers	Beholder	2019-11-08 07:51	3	2019-11-09 11:36	203
standby and retention samples standby and retention samples standby and retention samples Reserve samples? Spare subjects? Spare subjects? Spare subjects? standby and retention samples	zeynep	2019-10-24 12:22	7	2019-10-30 11:31	445
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 05:34	523
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 21:29	1,134
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	1,210
steady state for modified release steady state for modified release	Kelen	2019-09-20 20:04	1	2019-09-23 10:04	652
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	6,543
Reference replicated designs	rajasekharkakarla	2019-09-20 06:35	0		422
BA/BE for guidelines for ANVISA in English version ANVISA	Pandu	2019-09-10 05:30	1	2019-09-10 11:25	635
China Local BE study waiver China BE study China BE study	Ajit Thorat	2019-08-29 09:26	2	2019-09-04 15:15	812
Proportional or non proportional products	Mithu	2019-08-27 07:18	0		371
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	677