Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last Reply	Views
EMA Q&A vs EMA Product Specific guideline Crushed Rivaroxaban? Crushed Rivaroxaban?	Averroes	2017-10-04 12:01	2	2018-08-20 12:24	1,421
> 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	618
BE criteria BE criteria	rajasekharkakarla	2018-08-03 09:21	1	2018-08-06 20:35	2,207
Bioanalysis discontinued subject Bioanalysis discontinued subject Bioanalysis discontinued subject	Johanne	2018-08-02 00:31	2	2018-08-02 11:14	316
Reference trademark issue Note to File Note to File	rajasekharkakarla	2018-07-24 09:05	2	2018-07-30 13:37	319
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	507
95% UB criteria for FDA No rounding	sudy	2018-07-11 12:31	1	2018-07-11 14:31	434
BE study designs for ANVISA BE study designs for ANVISA BE study designs for ANVISA History…	ElMag	2011-05-11 09:11	3	2018-07-11 11:29	2,378
BE tables for topical (dental paste)?	jayashree iyengar	2018-07-05 21:29	0		296
Topical Drugs- IVRT	MaggieSantos	2018-07-03 18:41	0		262
Bio batch for Phase 1	Kim Christoper	2018-06-29 10:42	0		270
Potency correction - I still don't get it Potency correction - Only in exceptional cases Potency correction - Only in exceptional cases Potency correction: Rather why than when Potency correction: Rather why than when Potency correction: Upper limit? Potency correction - Example Potency correction - EAUnion opinion Potency correction - example Let me answer my own question Someone, somebody - slightly OT	ElMaestro	2018-06-23 10:14	10	2018-06-25 19:49	684
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?	Helmut	2013-12-10 14:05	15	2018-06-22 15:17	4,465
Report Preparation	lakshmiprasad	2018-06-20 05:56	0		294
Oral Dispersible Tablet BE study USFDA submission Oral Dispersible Tablet BE study USFDA submission Oral Dispersible Tablet BE study USFDA submission	Ramesh Ramalingam	2018-04-13 10:52	2	2018-05-31 13:37	1,026
Retention samples Retention samples	priyanka12345	2018-05-09 15:57	1	2018-05-31 13:29	593

Bioequivalence and Bioavailability Forum 15:35 CEST