Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	R’s	last reply	V’s
Exploratory pilot studies without filing IND	Regulatives / Guidelines	jag009	2017-10-02 16:12	0		308
BioBridges slides? BioBridges slides? BioBridges slides? BioBridges slides?	Conferences / Workshops	ElMaestro	2017-09-29 10:41	3	2017-09-29 14:40	680
Allocate screened volunteers to another BE project Allocate screened volunteers to another BE project Allocate screened volunteers to another BE project	Regulatives / Guidelines	TK	2017-09-28 05:20	2	2017-09-29 06:32	518
SOP for winNonlin and data quality control	Software	ssussu	2017-09-29 06:23	0		296
Lambda z programming Lambda z programming	Software	SP	2017-09-27 06:53	1	2017-09-28 06:04	459
Atorvastatin intra-subject Variability Atorvastatin intra-subject Variability Atorvastatin intra-subject Variability Atorvastatin intra-subject Variability	Study Assessment	Amira	2017-09-26 12:26	3	2017-09-27 11:05	568
Fampridine Fampridine Fampridine	Design Issues	MaggieSantos	2017-09-20 13:05	2	2017-09-26 11:23	506
Pivotal BE trial power not enough to 0.8 Pivotal BE trial power not enough to 0.8 Pivotal BE trial power not enough to 0.8	Power / Sample Size	ssussu	2017-09-22 07:40	2	2017-09-22 09:21	617
Tizanidine BA BE study Required pilot? Required pilot? Tizanidine BA BE study Tizanidine BA BE study	R for BE/BA	Salunke	2017-09-13 09:56	4	2017-09-22 07:38	701
Bioequivalence study under Korea submission Bioequivalence study under Korea submission	Regulatives / Guidelines	Ramesh Ramalingam	2017-09-20 11:43	1	2017-09-20 22:19	530
Potvin designs w. imbalance - what would you expect? Dropouts in stage 2 Dropouts continued	Two-Stage / GS Designs	ElMaestro	2017-08-17 13:02	2	2017-09-19 17:17	867
Odd QC values but not outliers Odd QC values but not outliers Odd QC values but not outliers Odd QC values but not outliers Odd QC values but not outliers	Bioanalytics	Thi Nguyen	2017-09-18 14:43	4	2017-09-19 13:49	517
Electronic Signature as per 21 CFR part 11	Regulatives / Guidelines	suhas14588	2017-09-18 12:38	0		364
Study population in biostudies in the EU: mixed or not? ♂ ¬ ♀ Study population in biostudies in the EU: mixed or not?	Regulatives / Guidelines	Marcel-Duclos Efoudebe	2017-09-14 16:31	2	2017-09-15 18:46	557
EMA Guideline: New BE Required Following API Source Change?	Regulatives / Guidelines	Mei San	2017-09-14 11:19	0		380
Usage of Light condition during study	Study Performance	anky1212	2017-09-13 08:47	0		337