Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	R’s	last reply	V’s
ANVISA and Malaysian authorities invitation to audit CRO ANVISA and Malaysian authorities invitation to audit CRO ANVISA and Malaysian authorities invitation to audit CRO	Regulatives / Guidelines	Quality-RJ	2016-11-01 09:07	2	2017-05-11 06:58	1,599
Such creativity Such creativity	GxP / QC / QA	ElMaestro	2017-05-10 11:36	1	2017-05-10 12:53	530
TRT / RTR Design TRT / RTR Design TRT / RTR Design TRT / RTR Design TRT / RTR Design TRT / RTR Design TRT / RTR Design TRT / RTR Design TRR / RTT Design TRR / RTT Design TRR / RTT Design TRR / RTT Design TRR / RTT Design TRR / RTT Design TRR / RTT Design	RSABE / ABEL	Yura	2017-05-01 09:34	14	2017-05-09 18:07	1,056
Bilingual SOPs Bilingual SOPs Bilingual SOPs	GxP / QC / QA	varadpradhan	2017-05-04 11:20	2	2017-05-09 02:51	566
Replacing a subject withdrawn for dose failure with a stand-by subject Replacing a subject withdrawn for dose failure with a stand-by subject Replacing a subject… Off topic: What is dose failure for a subling film?	Study Performance	VSP	2017-05-07 21:10	3	2017-05-08 22:16	457
endogenous compounds endogenous compounds endogenous compounds	Regulatives / Guidelines	martin	2017-05-08 19:50	2	2017-05-08 21:19	554
Inclusion of 3 consecutive non-zero conc data with Cmax as a last Con in PK	PK / PD	VSP	2017-05-07 21:53	0		296
Narrow Therapeutic Index- valproic acid and derivatives Narrow Therapeutic Index- valproic acid and derivatives	Regulatives / Guidelines	MaggieSantos	2017-04-26 18:20	1	2017-05-02 12:07	471
Revision of the BE-GL? ...and much more	BE/BA News	Helmut	2017-04-29 15:26	1	2017-04-29 15:58	457
question of adjustment TIE depends on CVwR (and n) TIE depends on CVwR (and n) TIE depends on CVwR (and n) TIE depends on CVwR (and n) TIE depends on CVwR (and n) TIE = p(BE) at expanded limits TIE = p(BE) at expanded limits	RSABE / ABEL	Yura	2017-04-25 15:14	7	2017-04-29 13:01	714
Anova table in Phoenix using the EMA model Get v6.4 Get v6.4 Get v6.4 Get v6.4	Software	mittyri	2015-11-16 06:27	4	2017-04-27 09:12	4,374
absorption phase and elimination phase absorption / elimination	PK / PD	VSP	2017-04-25 18:28	1	2017-04-26 13:26	501
Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE study Rationale for Partial AUCs in Naloxone hydrochloride nasal spray BE study	Regulatives / Guidelines	Gowthami	2017-04-25 12:13	1	2017-04-25 13:31	335
PK of new molecules PK of new molecules PK of new molecules PK of new molecules PK of new molecules	Design Issues	BE-proff	2017-04-18 06:25	4	2017-04-25 09:17	629
Regarding Statistical criteria for BE study of anticoagulant molecule Critical dose drugs Critical dose drugs Critical dose drugs - FDA highly variable NTID	Regulatives / Guidelines	suchit_bhavsar	2017-04-24 07:29	3	2017-04-25 08:41	477
including withdrew subject into statistical analysis	Regulatives / Guidelines	Satish	2017-04-25 06:15	0		223
Statistical analysis for more number of ambulatory samples.	Regulatives / Guidelines	VSP	2017-04-24 17:59	0		245
dose linearity Clavulanic acid dose linearity Clavulanic acid	PK / PD	pguelen	2017-04-19 21:16	1	2017-04-20 17:14	461