Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
“Before bioanalysis” interpretation – exclusion of subjects “Before bioanalysis” interpretation – exclusion of subjects “Before bioanalysis” interpretation – exclusion of subjects “Before bioanalysis” interpretation – exclusion of subjects “Before bioanalysis” interpretation – exclusion of subjects “Before bioanalysis” – exclusion of subjects “Before bioanalysis” – exclusion of subjects “Before bioanalysis” – exclusion of subjects	Dirk	2012-12-03 00:14	7	2012-12-05 13:04	6,481
change of name in investigational products change of name in investigational products change of name in investigational products change of name in investigational products Bad idea, IMHO Bad idea, IMHO	vivekanand	2012-11-24 14:40	5	2012-11-27 13:25	4,457
EMEA CI on treatment, period & sequence effects EMA: no CI on period & sequence effects EMA: no CI on period & sequence effects EMA: Veterinary (!) BE	qwerty12	2012-11-26 22:11	3	2012-11-26 22:59	4,798
Two topical gel formulations with one oral tablet	yogesh1004	2012-11-19 12:16	0		1,732
Replicate study design for Brazil submission ANVISA – likely no scaling ANVISA – likely no scaling ANVISA: strange	balakotu	2012-11-14 09:49	3	2012-11-16 13:14	4,695
Retention requirements for comparator Retention requirements for comparator Retention requirements for comparator	AUClast	2012-11-08 18:46	2	2012-11-09 10:24	4,865
Retention quantity for Europe Submission study Retention quantity for Europe Submission study Retention quantity for Europe Submission study	achintparikh	2012-11-03 12:44	2	2012-11-07 05:01	13,062
Tox studies before generic BE Tox studies before generic BE Yes, but why the heck? Clearly because... Yes, but why the heck?	Helmut	2012-11-04 17:25	4	2012-11-06 03:43	3,835
IEC Registration IEC Registration	santosh	2012-11-02 13:19	1	2012-11-02 16:42	2,416
Need Help: History lessons on FDA BABE Need Help: History lessons on FDA BABE	jag009	2012-10-23 21:19	1	2012-10-24 11:02	3,359
Does Inhalation Aerosol require BE? Does Inhalation Aerosol require BE? Does Inhalation Aerosol require BE? Does Inhalation Aerosol require BE? Does Inhalation Aerosol require BE?	Jasim Uddin	2012-10-22 07:16	4	2012-10-22 21:27	3,946
Statistical analysis (ANVISA)	k1612	2012-10-18 18:59	0		1,685
Tmax differences in BE studies Delayed release? Delayed release? CR? CR? t75%, HVD CR?	jag009	2012-10-15 16:23	6	2012-10-16 19:22	5,196
Steady State Study Criteria for Pre-dose Steady State Study Criteria for Pre-dose	sandipmumbai	2012-10-16 09:13	1	2012-10-16 13:18	2,844
SAE reporting SAE reporting	Compliance	2012-10-12 08:18	1	2012-10-13 19:23	2,522