Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
archival period of Study documents as Per FDA, ANVISA, EMEA guidelines	vivekb2	2018-10-27 07:59	0		2,530
FDA: Size of bio-batch FDA: Size of bio-batch FDA: antique of ’93 FDA: antique of ’93 FDA: antique of ’93 FDA: antique of ’93 FDA: antique of ’93 FDA: antique of ’93 Patience FDA: antique of ’93 Nice numbers Nice numbers Type II variation Birdsong's third law of BE Experience Why, oh why? Sorry for the delay	Helmut	2013-12-10 14:05	16	2018-10-18 07:40	18,921
Enoxaparin sodium injection BA BE studies BE of parenterals Enoxaparin sodium injection BA BE studies Enoxaparin sodium injection BA BE studies Enoxaparin sodium injection BA BE studies Enoxaparin sodium injection BA BE studies	varsha chungde	2018-10-08 11:34	5	2018-10-10 05:11	5,818
Retention of BA/BE samples	Neelu Singh	2018-10-05 06:57	0		2,786
Pivotal study documentation for submission	Amalia	2018-09-24 14:22	0		2,193
Reference Scale Average Bioequivalence Approach: ANVISA, Brazil RSABE - ANVISA	Maitri	2018-09-21 19:49	1	2018-09-22 12:11	4,076
Sample size determination for in-vitro superiority study	sudy	2018-09-21 08:46	0		2,191
Usage of different lots of RLDs in multistage adaptive studies Usage of different lots of RLDs in multistage adaptive studies Usage of different lots of RLDs in multistage adaptive studies	manusyriac	2018-09-20 09:45	2	2018-09-20 11:05	3,757
Endogenous NTI drugs	NK	2018-09-19 07:31	0		2,277
FDA Supac guidance for ER FDA Supac guidance for ER FDA Supac guidance for ER	jag009	2018-09-07 20:31	2	2018-09-10 16:38	3,795
> 5% of Cmax for endogenous molecule? Any own thoughts? carryover effect in endogenous substances	Ramesh Ramalingam	2018-06-18 08:00	2	2018-08-08 05:29	5,885
BE criteria BE criteria	rajasekharkakarla	2018-08-03 09:21	1	2018-08-06 18:35	6,051
Bioanalysis discontinued subject Bioanalysis discontinued subject Bioanalysis discontinued subject	Johanne	2018-08-02 00:31	2	2018-08-02 09:14	4,361
Reference trademark issue Note to File Note to File	rajasekharkakarla	2018-07-24 09:05	2	2018-07-30 11:37	4,076
Not using Biostrength for BE Not using Biostrength for BE Not using Biostrength for BE Not using Biostrength for BE	zheng791	2018-07-13 21:31	3	2018-07-17 04:46	4,722