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	5,042
Warfarin Guidance Warfarin Guidance Warfarin Guidance	jag009	2016-06-22 19:43	2	2016-06-27 14:40	5,918
Iron Sucrose	mmw	2016-06-23 08:06	0		2,987
Iron Content Iron Content	hari emmadi	2016-06-04 09:01	1	2016-06-04 07:38	3,663
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	7,228
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	4,929
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	13,192
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	15,579
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	4,008
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	5,283
ANVISA Requirement ANVISA Requirement ANVISA Requirement	suchit_bhavsar	2016-04-28 08:37	2	2016-05-18 13:43	4,226
FDA: NTI drugs FDA: NTI drugs; switching condition	jag009	2016-05-15 22:26	1	2016-05-16 12:15	5,237
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	6,727
IRB Subjects rights Right to leave	krish	2016-05-06 08:16	2	2016-05-09 10:30	3,754
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	4,319