Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Allocate screened volunteers to another BE project Allocate screened volunteers to another BE project Allocate screened volunteers to another BE project	TK	2017-09-28 05:20	2	2017-09-29 04:32	5,757
Bioequivalence study under Korea submission Bioequivalence study under Korea submission	Ramesh Ramalingam	2017-09-20 11:43	1	2017-09-20 20:19	4,444
Electronic Signature as per 21 CFR part 11	suhas14588	2017-09-18 12:38	0		2,344
Study population in biostudies in the EU: mixed or not? ♂ ¬ ♀ Study population in biostudies in the EU: mixed or not?	Marcel-Duclos Efoudebe	2017-09-14 16:31	2	2017-09-15 16:46	5,493
EMA Guideline: New BE Required Following API Source Change?	Mei San	2017-09-14 11:19	0		2,493
subject sample analysis and inclusion criteria in PK and stat analysis	Ramesh Ramalingam	2017-09-12 12:54	0		2,618
syrup hybrid application syrup hybrid application syrup hybrid application syrup hybrid application syrup hybrid application	Aga	2017-09-06 13:52	4	2017-09-07 12:54	7,791
Enlighten me please Enlighten me please Enlighten me please Enlighten me please	jag009	2017-09-06 21:11	3	2017-09-07 04:16	6,871
subject inclusion criteria in PK and stat and BE conclusion subject inclusion criteria in PK and stat and BE conclusion subject inclusion criteria in PK and stat and BE conclusion subject inclusion criteria in PK and stat and BE conclusion subject inclusion criteria in PK and stat and BE conclusion subject inclusion criteria in PK and stat and BE conclusion At least twice R or twice T for sWR and sWT	Ramesh Ramalingam	2017-09-05 07:35	6	2017-09-05 13:23	9,256
CFDA and reference scaling CFDA and reference scaling CFDA and reference scaling CFDA and reference scaling OT: Uplading / attaching files CFDA: seemingly like the EMA CFDA: seemingly like the EMA CFDA and reference scaling CFDA and reference scaling CFDA and reference scaling CFDA and reference scaling	BRB	2017-07-20 15:44	10	2017-08-29 16:51	19,721
EMA Steady State Fed Study breakfast EMA Steady State Fed Study breakfast EMA Steady State Fed Study breakfast EMA Steady State Fed Study breakfast EMA Steady State Fed Study breakfast EMA Steady State Fed Study breakfast	Jay	2015-06-02 12:43	5	2017-08-23 16:14	10,423
Latest FDA product-specific guidelines – Some questions… Latest FDA product-specific guidelines – Some questions… Latest FDA product-specific guidelines – Some questions… Latest FDA product-specific guidelines – Some questions… Latest FDA product-specific guidelines – Some questions… Standardisation of the population Standardisation of the population Latest FDA product-specific guidelines – Some questions… Latest FDA product-specific guidelines – Some questions…	nobody	2017-07-19 10:56	8	2017-07-26 14:27	13,018
Revised EMA guideline on first-in-human and early phase studies	Ohlbe	2017-07-25 18:52	0		2,669
PC PP domains for CDISC submission PC PP domains for CDISC submission ADaM and SDTM files submission question for Generic products ADaM and SDTM files submission question for Generic products	Abc123	2017-05-29 12:45	3	2017-07-24 16:53	7,435
multiple dose steady state BE and emesis criteria multiple dose steady state BE and emesis criteria multiple dose steady state BE and emesis criteria regression of pre-dose concentrations Which method for SS achievement? IR and MR: pre-specified!	Mahesh M	2017-07-06 06:45	5	2017-07-23 09:52	8,634