Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Recommendations to bioequivalence study of Rivaroxaban: FDA vs EMA	Mauricio Sampaio	2017-07-19 16:55	0		3,734
Bioequivalence study of class II molecule BE of Schedule II drug (India) BE of Schedule II drug (India) BE of Schedule II drug (India)	bhargavj12	2017-07-10 19:59	3	2017-07-14 03:52	5,917
FDA BE Guide Warfarin – never used? FDA BE Guide Warfarin – never used? FDA BE Guide Warfarin – never used? Sample sizes are not prohibitive Sample sizes are not prohibitive Sample sizes are not prohibitive	nobody	2017-07-13 15:13	5	2017-07-13 18:36	7,752
Highly Variable Drug BE Justification Highly Variable Drug BE Justification Study costs: Replicate vs. 2×2×2 Study costs: Replicate seems to be cheaper Study costs: Replicate seems to be cheaper Study costs: Replicate seems to be cheaper expected power Doesn't hurt! Study costs: Replicate vs. 2×2×2 Study costs: Replicate vs. 2×2×2 Replicate vs. 2×2×2 (ethics?) Replicate vs. 2×2×2 (ethics?) Applicability of reference-scaling Replicate vs. 2×2×2 Replicate vs. 2×2×2 Replicate vs. 2×2×2 Regulators view of HVD drugs Regulators view of HVD drugs What's the problem? What's the problem? What's the problem? What's the problem? What's the problem? What's the problem? What's the problem?	jag009	2017-03-20 04:42	24	2017-07-11 12:56	28,181
Russian BE requirement Russian BE requirement Russian BE requirement Russian BE requirement Russian BE requirement List of accredited clinical sites Russian BE requirement Russian BE requirement	Rasha_J	2016-05-15 10:39	7	2017-06-23 08:13	11,182
LIMS LIMS	Rasha_J	2017-06-06 11:51	1	2017-06-06 11:20	4,821
Incurred sample reanalysis Incurred sample reanalysis Incurred sample reanalysis	sushil.pimpare	2017-06-06 07:53	2	2017-06-06 10:10	5,947
change in CC range exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) exact matching of CCs (validation’s and study’s) Sapere aude!	sushil.pimpare	2017-05-31 09:31	7	2017-05-31 13:38	9,434
CDISC domains CDISC domains CDISC domains	arl_stat	2017-05-17 08:42	2	2017-05-20 06:41	4,535
Pharmacokinetic parameters CL, Vd and F Pharmacokinetic metrics CL, Vd and F Pharmacokinetic metrics CL, Vd and F CFDA 2016 BE-GL CFDA 2016 BE-GL nonlinear PK: highest dose ⇔ strength highest dose ⇔ strength for dummies highest dose ⇔ strength for dummies highest dose ⇔ strength for dummies highest dose ⇔ strength for dummies highest dose ⇔ strength for dummies highest dose ⇔ strength for dummies	mmw	2017-05-06 11:07	11	2017-05-15 04:53	13,593
ANVISA and Malaysian authorities invitation to audit CRO ANVISA and Malaysian authorities invitation to audit CRO ANVISA and Malaysian authorities invitation to audit CRO	Rasha_J	2016-11-01 09:07	2	2017-05-11 04:58	5,359
endogenous compounds endogenous compounds endogenous compounds	martin	2017-05-08 19:50	2	2017-05-08 19:19	5,577
Narrow Therapeutic Index- valproic acid and derivatives Narrow Therapeutic Index- valproic acid and derivatives	MaggieSantos	2017-04-26 18:20	1	2017-05-02 10:07	4,230
Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE study Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE study	Gowthami	2017-04-25 12:13	1	2017-04-25 11:31	4,152
Regarding Statistical criteria for BE study of anticoagulant molecule Critical dose drugs Critical dose drugs Critical dose drugs - FDA highly variable NTID	suchit_bhavsar	2017-04-24 07:29	3	2017-04-25 06:41	4,975