Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	R’s	last reply	V’s
SAS: 3 questions need to be answered 1st warning 1st warning 1st warning 1st warning	Software	Mohamed Yehia	2017-07-31 15:32	4	2017-07-31 18:07	438
Non Normal Shapiro-Wilk Test Non Normal Shapiro-Wilk Test Non Normal Shapiro-Wilk Test significant Shapiro-Wilk Test significant Shapiro-Wilk Test significant Shapiro-Wilk Test	General Statistics	Mohamed Yehia	2017-07-29 20:47	5	2017-07-31 12:52	361
Confidence Interval For Tmax Confidence Interval For Tmax Confidence Interval For Tmax Confidence Interval For Tmax	Nonparametrics	Mohamed Yehia	2017-07-29 22:10	3	2017-07-30 14:41	324
T1 and T2 of Schuirmann test for bioequivalence T1 and T2 of TOST T1 and T2 of TOST	General Statistics	Mohamed Yehia	2017-07-28 21:00	2	2017-07-29 20:38	354
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…	Regulatives / Guidelines	nobody	2017-07-19 10:56	8	2017-07-26 16:27	775
package ncappc in R package ncappc in R package ncappc in R	R for BE/BA	daryazyatina	2017-07-25 15:12	2	2017-07-26 08:09	346
Revised EMA guideline on first-in-human and early phase studies	Regulatives / Guidelines	Ohlbe	2017-07-25 18:52	0		219
Does anyone have R-code for BE computations package bear package bear R-code for RSABE	R for BE/BA	Achievwin	2017-07-23 16:04	3	2017-07-24 20:47	399
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	Regulatives / Guidelines	Abc123	2017-05-29 12:45	3	2017-07-24 18:53	787
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	Regulatives / Guidelines	BRB	2017-07-20 15:44	6	2017-07-24 18:47	541
How to create table of results How to create table of results How to create table of results How to create table of sample sizes / powers How to create table of sample sizes / powers Symmetrical in log-scale Symmetrical in log-scale RTFM	Power / Sample Size	BE-proff	2017-07-20 14:09	7	2017-07-24 18:18	496
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!	Regulatives / Guidelines	Mahesh M	2017-07-06 06:45	5	2017-07-23 11:52	654
variability variability variability variability (SAS)	General Statistics	ioanam	2008-12-20 12:57	3	2017-07-22 12:06	7,916
Calcitriol Calcitriol: After 0.5 µg Cmax <2× basal level Calcitriol: After 0.5 µg Cmax <2× basal level	Bioanalytics	jag009	2017-07-20 22:47	2	2017-07-21 21:19	360
Predict Bioavailability from Cmax and Half life Predict Bioavailability from Cmax and Half life Predict Bioavailability from Cmax and Half life	PK / PD	ViPraj	2017-07-20 07:45	2	2017-07-20 13:00	326
Requirement of temperature data before dosing Requirement of temperature data before dosing Requirement of temperature data before dosing Requirement of temperature data before dosing Requirement of temperature data before dosing Requirement of temperature data before dosing	Study Performance	anky1212	2017-07-20 08:08	5	2017-07-20 12:13	418