Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Paliperidone injection - waiver option Paliperidone injection - waiver option Paliperidone injection - waiver option Dose ≠ strength	msmnainar	2016-07-01 08:53	3	2016-07-04 08:16	5,035
Warfarin Guidance Warfarin Guidance Warfarin Guidance	jag009	2016-06-22 19:43	2	2016-06-27 14:40	5,913
Iron Sucrose	mmw	2016-06-23 08:06	0		2,981
Iron Content Iron Content	hari emmadi	2016-06-04 09:01	1	2016-06-04 07:38	3,658
Revision of WHO guidance for CROs Revision of WHO guidance for CROs Published	Ohlbe	2015-05-27 14:42	2	2016-06-02 14:05	7,225
Partial AUC & Cmax in case of multiphasic modified release drug product The x unveiled The x unveiled Biphasic: x=2	maulik963	2016-05-31 08:09	3	2016-06-02 12:07	4,921
truncated design FDA: AUC0–72 FDA: AUC0–72 FDA: crystal ball FDA: crystal ball	Mahesh M	2015-12-29 11:21	4	2016-05-26 22:01	13,184
ANVISA and replicate designs ANVISA and replicate designs ANVISA and replicate designs ANVISA = EMA’s ABEL! ANVISA = EMA’s ABEL! Method A, B (or C?) ANVISA = EMA’s ABEL! ANVISA = EMA’s ABEL?	d_labes	2016-05-11 09:47	7	2016-05-24 07:46	15,571
What if the References listed drug changed strength? What if the References listed drug changed strength? What if the References listed drug changed strength? What if the References listed drug changed strength?	jag009	2016-05-20 17:26	3	2016-05-20 19:48	4,004
Pharmacokinetic interaction study FDCPs: generally BE (higher BA under certain conditions) FDCPs: generally BE (higher BA under certain conditions) FDCPs: generally BE (higher BA under certain conditions) Pharmacokinetic interaction study Pharmacokinetic interaction study	Mahesh M	2016-05-12 07:07	5	2016-05-20 07:40	5,278
ANVISA Requirement ANVISA Requirement ANVISA Requirement	suchit_bhavsar	2016-04-28 08:37	2	2016-05-18 13:43	4,219
FDA: NTI drugs FDA: NTI drugs; switching condition	jag009	2016-05-15 22:26	1	2016-05-16 12:15	5,231
should sprinkle BE study be in fasting condition only or also in fed? To fast or not to fast To fast or not to fast should sprinkle BE study be in fasting condition only or also in fed?	chloe	2016-04-27 04:44	3	2016-05-09 21:14	6,724
IRB Subjects rights Right to leave	krish	2016-05-06 08:16	2	2016-05-09 10:30	3,752
EU reference product - no originator available No EU originator available: bad luck No EU originator available: bad luck no originator = no generic no originator = no generic	nobody	2016-04-27 09:22	4	2016-04-27 14:31	4,318