Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
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 09:40	5,020
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 07:11	355
Test License Test License Test License	rajasekharkakarla	2018-10-06 08:05	2	2018-10-07 21:04	234
Retention of BA/BE samples	Neelu Singh	2018-10-05 06:57	0		208
Pivotal study documentation for submission	Amalia	2018-09-24 14:22	0		261
Reference Scale Average Bioequivalence Approach: ANVISA, Brazil RSABE - ANVISA	Maitri	2018-09-21 19:49	1	2018-09-22 14:11	371
Sample size determination for in-vitro superiority study	sudy	2018-09-21 08:46	0		214
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 13:05	320
Endogenous NTI drugs	NK	2018-09-19 07:31	0		288
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 18:38	358
EMA Q&A vs EMA Product Specific guideline Crushed Rivaroxaban? Crushed Rivaroxaban?	Averroes	2017-10-04 12:01	2	2018-08-20 12:24	1,809
> 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 07:29	884
BE criteria BE criteria	rajasekharkakarla	2018-08-03 09:21	1	2018-08-06 20:35	2,467
Bioanalysis discontinued subject Bioanalysis discontinued subject Bioanalysis discontinued subject	Johanne	2018-08-02 00:31	2	2018-08-02 11:14	528
Reference trademark issue Note to File Note to File	rajasekharkakarla	2018-07-24 09:05	2	2018-07-30 13:37	492
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 06:46	699

Bioequivalence and Bioavailability Forum 08:02 UTC