Bioequivalence and Bioavailability Forum

Subject	Category	Author	Date	Replies	Last reply	Views
2012 events listing 3rd World Congress on BABE-2012, 26-28 March, Hyderabad 2nd World Congress Going Off-Topic ♠♣♥♦ Cross-over Trials by Stephen Senn	Conferences / Workshops	HS	2011-10-10 03:15	4	2012-01-16 17:22	1203
Guidance Documents ...other Sources Requests for Update Questions for regulatory requirements… Redesign of FDA's website :-(	Regulatives / Guidelines	HS	2006-01-20 23:28	4	2009-06-08 15:24	24711
Strength selection Strength selection Strength selection	Design Issues	Paresh	2012-01-27 06:47	2	2012-01-28 11:29	49
EMA - Exclusion of data EMA - Exclusion of data EMA - Exclusion of data LSMeans? LSMeans?	Regulatives / Guidelines	d_labes	2012-01-24 11:09	4	2012-01-26 13:22	159
Paper on RSABE/ABEL Paper on RSABE/ABEL Paper on RSABE/ABEL Hyslop/Howe Hyslop/Howe FARTSSIE on RSABE/ABEL FARTSSIE on RSABE/ABEL PowerTOST vs. simulation on ABEL	Power / Sample Size	HS	2012-01-04 15:46	7	2012-01-26 10:44	365
Subject to include in BE protocol (FDA SABE approach)	Regulatives / Guidelines	Shuanghe	2012-01-26 09:44	0		50
Dissolution of Effervescent Tablets	Study Performance	joyjac	2012-01-26 03:48	0		32
clinical trials/ BE studies for locally acting drugs	Regulatives / Guidelines	jagankm	2012-01-25 11:26	0		40
SD’s Cτ predictive of MD BE?	PK Metrics	HS	2012-01-24 16:45	0		71
Sample Size Calculation for partial and full replicate study The power to know - no The power to know - no Sample size tables used Not that easy at all	Regulatives / Guidelines	balakotu	2012-01-24 09:44	4	2012-01-24 13:26	172
Calibration Curve Duplicate LLOQ and ULOQ Duplicate LLOQ and ULOQ Duplicate LLOQ and ULOQ Duplicate LLOQ and ULOQ Calibration Curve Calibration Curve Calibration Curve Calibration Curve	Bioanalytics	auditor	2012-01-20 11:15	8	2012-01-22 21:48	227
Expedited Review from IEC in case of change in study design Expedited Review from IEC in case of change in study design Expedited Review from IEC in case of change in study design New trial = new opinion Sample size: parallel ≠ 2× cross-over! Expedited Review from IEC in case of change in study design Expedited Review from IEC in case of change in study design	Regulatives / Guidelines	amatewadi	2012-01-09 12:46	6	2012-01-22 14:26	323
study sample analysis study sample analysis	Bioanalytics	Falisa_Mustafa	2012-01-20 04:06	1	2012-01-20 13:22	125
Tmax in Partial Replicate Design Good question! Good question! Early exposure (+scaling?) Tmax in Partial replicate design Tmax in Partial replicate design Intra-subject contrast (difference) Intra-subject contrast (difference)	Nonparametrics	Joshua	2012-01-17 06:59	7	2012-01-20 13:01	296
Design the generic ophthalmic solutions clinical trials Design the generic ophthalmic solutions clinical trials	Design Issues	gore.lalit	2012-01-20 05:26	1	2012-01-20 08:31	155
SAS and missing values SAS and missing values THX & another request Congratulations for both of us :-D FDA's RSABE: Phoenix ‘validated’ against SAS How to obtain CINV value in Phoenix Import from external source Thanks, it's done!! Thanks, it's done!!	Software	HS	2012-01-06 01:47	8	2012-01-20 00:10	391
FDA enforcing QbD from 2013 FDA enforcing QbD from 2013	Dissolution / BCS/IVIVC	ElMaestro	2012-01-19 15:19	1	2012-01-19 15:48	146
Spiking in plasma more then 5% Spiking in plasma more then 5%	Bioanalytics	auditor	2012-01-19 08:47	1	2012-01-19 11:19	96
Biowaiver of strengh in fixed combinatios	Regulatives / Guidelines	Averroes	2012-01-18 13:05	0		107
WHO BTIF WHO BTIF WHO BTIF WHO BTIF WHO BTIF WHO BTIF WHO BTIF Inter- or intra-subject CV? intrasubject intrasubject intrasubject	Regulatives / Guidelines	K2K	2012-01-12 05:15	10	2012-01-18 09:36	365
manual power calculation manual power calculation: why? manual power calculation: why? FARTSSIE.xls FARTSSIE.xls CV from CI: manual, PowerTOST, FARTSIE.xls CV from CI: manual, PowerTOST, FARTSIE.xls	Power / Sample Size	Karthik	2011-03-17 10:17	6	2012-01-18 09:35	1514
Biowaiver Monographs Biowaiver Monographs (Update) Biowaiver Monographs (Update) Biowaiver Monographs (new FIP link) Biowaiver Monographs (Update) Biowaiver Monographs (Update) Biowaiver Monographs (Update) Biowaiver Monographs (Update) Biowaiver Monographs (Update) Dodium and the end of world Biowaiver Monographs (Update) Biowaiver Monographs (Update) Biowaiver Monographs (Update) Biowaiver Monographs (Update)	Dissolution / BCS/IVIVC	HS	2006-06-02 17:57	13	2012-01-17 17:50	8644
Power for unbalanced cross-over Great post! Santa is coming PowerTOST BIBDs Uuups PowerTOST robust	Power / Sample Size	d_labes	2011-01-14 15:21	6	2012-01-17 11:53	1335
bracketing approach	Regulatives / Guidelines	ioanam	2012-01-16 19:06	0		104
Bioequivalence of racemic drugs using non-steriospecific bio BE of racemic drugs (EMA vs. FDA) BE of racemic drugs (EMA vs. FDA) BE of racemic drugs (EMA’s practice) BE of racemic drugs (EMA’s practice)	Regulatives / Guidelines	scorp2011	2012-01-12 13:21	4	2012-01-16 13:08	236
need to change software need to change software need to change software Alternative software Alternative software	Software	Pin	2012-01-10 05:05	4	2012-01-16 08:51	229
Study Design for Aspirin	Design Issues	auditor	2012-01-16 06:50	0		123
high fat high calorie breakfast menu for oncolgy patients high fat high calorie breakfast menu for oncolgy patients (Semi)solids’ viscosities	Regulatives / Guidelines	Brijesh Wadekar	2012-01-12 06:07	2	2012-01-13 17:48	173
Montelukast study Montelukast study tablets Chewable tablets (EMA) Chewable tablets (EMA) Chewable tablets (EMA) Montelukast study Montelukast study FDA’s guidances, lightsensitive drugs FDA’s guidances, lightsensitive drugs Lightsensitive drugs	Design Issues	Phaneendra.K	2010-12-31 15:06	10	2012-01-13 17:26	1696
BE of Effervescent Tablets BE of Effervescent Tablets Check absorption!	Study Performance	joyjac	2012-01-12 09:45	2	2012-01-13 17:11	185
endogenous compounds To diff or not to diff, that’s the question To diff or not to diff, that’s the question To diff or not to diff, that’s the question nasty questions quick answers	PK Metrics	martin	2012-01-11 21:02	5	2012-01-13 16:09	259
Validation of excel software At least not for EMA… Validation of excel software Validation of excel software	Software	stdev	2012-01-11 19:01	3	2012-01-13 00:23	226
Issue of Alcohol Dose dumping Alcohol induced dose dumping (in vitro, FDA) Alcohol induced dose dumping (in vitro, FDA) Alcohol induced dose dumping (in vitro, FDA)	Regulatives / Guidelines	Chiku	2012-01-11 08:10	3	2012-01-12 16:50	169
selected strengths	Regulatives / Guidelines	ioanam	2012-01-11 22:55	0		112
Full Replicate BE study! Calculation Issues Full Replicate BE study! Calculation Issues Evaluation according to design	Regulatives / Guidelines	luvblooms	2011-12-16 16:46	2	2012-01-10 18:22	391