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	1391
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	24814
anova in BE	General Statistics	AB	2012-02-05 15:21	0		4
BMI vs LIC for age and weight chart Between subject differences in Xovers	Regulatives / Guidelines	Vardhan82	2012-02-03 06:26	1	2012-02-04 11:30	59
Dissolution of Effervescent Tablets Dissolution of Effervescent Tablets	Study Performance	joyjac	2012-01-26 03:48	1	2012-02-04 10:58	91
Bioequivalence criteria for endogenous drug Bioequivalence criteria for endogenous drug	Regulatives / Guidelines	pash413	2012-02-03 12:15	1	2012-02-04 05:31	100
DCGI BE-NOC DCGI BE-NOC DCGI BE-NOC DCGI BE-NOC DCGI BE-NOC DCGI BE-NOC	Regulatives / Guidelines	rave04	2012-02-03 06:10	5	2012-02-03 13:19	116
Change in ULOQ concentration	Bioanalytics	auditor	2012-02-03 08:28	0		62
Biosimilars Biosimilars Biosimilars Healthy subjects vs. patients Biosimilars Biosimilars	Design Issues	M.Vasu	2011-11-24 14:01	5	2012-02-03 06:43	735
Statistical Out come Statistical Out come Statistical Out come	General Statistics	auditor	2012-02-01 12:58	2	2012-02-02 19:13	138
Estimation on Kel, AUCi, Thalf	PK Metrics	MGR	2012-02-02 05:48	0		89
BE of Effervescent Tablets BE of Effervescent Tablets Check absorption! BE of Effervescent Tablets BE of Effervescent Tablets BE of Effervescent Tablets BE of Effervescent Tablets	Study Performance	joyjac	2012-01-12 09:45	6	2012-02-01 04:01	325
clinical trials/ BE studies for locally acting drugs clinical trials/ BE studies for locally acting drugs clinical trials/ BE studies for locally acting drugs	Regulatives / Guidelines	jagankm	2012-01-25 11:26	2	2012-01-31 19:01	159
unknown linearity linear PK required for biowaiver ... or knowledge of non-linearity ... or knowledge of non-linearity	Regulatives / Guidelines	kudra23	2012-01-30 10:30	3	2012-01-31 18:18	156
acceptance criteria of calibration standards acceptance criteria of calibration standards acceptance criteria of calibration standards acceptance criteria of calibration standards	Bioanalytics	haydonat	2012-01-30 14:27	3	2012-01-31 18:05	154
Sample Size Replicated Study Sample Size Replicated Study Sample Size Replicated Study Sample Size Replicated Study Sample Size Replicated Study 4-treatment-4-period study 4-treatment-4-period study Clinical study	Power / Sample Size	ashwinim13	2008-08-18 10:42	7	2012-01-31 16:38	2021
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!! SAS and missing values	Software	HS	2012-01-06 01:47	9	2012-01-31 03:12	492
Strength selection Strength selection Strength selection Strength selection Strength selection Swiss reference? Swiss reference? EU reference!	Design Issues	Paresh	2012-01-27 06:47	7	2012-01-29 03:51	250
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	280
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	468
Subject to include in BE protocol (FDA SABE approach)	Regulatives / Guidelines	Shuanghe	2012-01-26 09:44	0		137
SD’s Cτ predictive of MD BE?	PK Metrics	HS	2012-01-24 16:45	0		127
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	293
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	319
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	409
study sample analysis study sample analysis	Bioanalytics	Falisa_Mustafa	2012-01-20 04:06	1	2012-01-20 13:22	174
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	371
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	212
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	206
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	173
Biowaiver of strengh in fixed combinatios	Regulatives / Guidelines	Averroes	2012-01-18 13:05	0		151
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	460
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	1576
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	8759
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	1403