Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Stem Cell Export Noc Stem Cell Export Noc	pramodbatkhal	2014-03-12 15:46	1	2014-03-14 17:35	2,735
Drowsiness TEAE TEAE TEAE TEAE TEAE OT AE definition in BEQ study Great post!	Rajdoc	2014-03-11 12:08	8	2014-03-14 13:39	5,001
biosimilarity on LMWH in EU	Clarc	2014-03-13 10:05	0		1,649
Retention of IPs for BE studies Retention of IPs for BE studies	Kuldeep Namdev	2014-03-05 12:46	1	2014-03-05 13:44	3,942
Bioanalytical method validation -compliance-topical steroid Bioanalytical method validation -compliance-topical steroid Bioanalytical method validation -compliance-topical steroid Easy Easy Easy	Tina	2014-02-25 12:39	5	2014-02-27 13:18	4,016
Justification for reanalysis Justification for reanalysis	Dr Naghma Hashmi	2014-02-27 10:39	1	2014-02-27 10:33	2,828
Sample size + Limits Drug Interaction study FDA: DDI Interaction FDA: DDI Interaction FDA: DDI Interaction FDA: DDI Interaction FDA: DDI Interaction	hiren379	2014-02-19 13:38	5	2014-02-20 21:27	5,856
BE for HVD (EMA) BE for HVD (EMA): no 2x2 crossover CV >30% in the study BE for HVD (EMA) BE for HVD (EMA) EMA: No widening of acceptance limits for AUC BE for HVD (EMA) BE for HVD (EMA) Single point metric… Single point metric… Single point metric… Single point metric… MR GL – when?	nasir	2014-02-14 06:38	12	2014-02-19 12:10	6,848
DCGI	bharat narnavar	2014-02-17 08:11	0		1,578
WHO Accreditation WHO Accreditation	Dr Naghma Hashmi	2014-02-14 08:34	1	2014-02-14 08:16	2,878
Sequence Effect on Endogenous Drugs Sequence Effect on Endogenous Drugs Sequence Effect on Endogenous Drugs Sequence Effect on Endogenous Drugs Sequence Effect on Endogenous Drugs Sequence Effect on Endogenous Drugs Sequence Effect on Endogenous Drugs Sequence Effect on Endogenous Drugs Sequence Effect on Endogenous Drugs Sequence Effect on Endogenous Drugs Curious Sequence Effect on Endogenous Drugs Four studies with the same formulation Four studies with the same formulation	Lucas	2014-02-10 20:01	13	2014-02-11 19:01	11,379
Retention of testing sample	gracehung	2014-02-11 11:44	0		1,600
Group sequential designs – Canada Group sequential designs – Canada	d_labes	2014-02-07 15:43	1	2014-02-07 15:15	2,605
Draft Guidance on Topiramate June 2012	AR	2014-02-07 07:34	0		1,509
Precision of Numbers for Report Precision of Numbers for Report Precision of Numbers for Report To round or not to round…	AngusMcLean	2014-02-04 03:14	3	2014-02-06 00:38	3,286