Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	R’s	last reply	V’s
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		30,285
Marginally failed study for Europe Marginally failed study for Europe	Regulatives / Guidelines	balakotu	2018-04-24 07:30	1	2018-04-24 12:31	150
F2 Calculation For Rapidly Dissolving FPPs Sample after >85% release Sample after >85% release Sample after >85% release Sample after >85% release Sample after >85% release Sample after >85% release Sample after >85% release Sample after >85% release FPP FPP	Dissolution / BCS / IVIVC	Obinoscopy	2018-04-22 15:11	10	2018-04-27 03:23	460
Finally: Exact TSD methods for 2×2 crossover designs Exact TSD methods: Example Finally: Exact TSD methods for 2×2 crossover designs Flow chart (without details) Technicality: Weigths for the inverse normal approach Selection of w and w* Selection of w and w*	Two-Stage / GS Designs	Helmut	2018-04-21 17:17	6	2018-04-26 20:02	707
BCS III Classification BCS-based biowaivers for Class III BCS-based biowaivers for Class III	Dissolution / BCS / IVIVC	Obinoscopy	2018-04-20 08:09	2	2018-04-20 16:06	367
BE parallel studies with more than 2 arms BE parallel studies with more than 2 arms BE parallel studies with more than 2 arms	Power / Sample Size	Louis52	2018-04-18 20:18	2	2018-04-23 21:20	301
Biowaiver of Product with TE code AA	Regulatives / Guidelines	rajibkumar	2018-04-18 07:37	0		181
Bioanalysis Forum policy	Bioanalytics	Deepti Maru	2018-04-17 18:48	1	2018-04-18 09:56	319
Diclofenac Powder for oral solution	Design Issues	lakshmiprasad	2018-04-17 13:25	0		179
oral powder with water acceptable? oral powder with water acceptable? oral powder with water acceptable? oral powder with water acceptable? oral powder with water acceptable? oral powder with water acceptable? oral powder with water acceptable? oral powder with water acceptable? oral powder with water acceptable?	Regulatives / Guidelines	chris089	2018-04-16 13:43	8	2018-04-19 18:36	656
Shenanigans	BE/BA News	ElMaestro	2018-04-15 14:50	0		254
Numerical Deconvolution Numerical Deconvolution	Dissolution / BCS / IVIVC	VH	2018-04-15 13:56	1	2018-04-16 12:12	386
Zero Sample Preparation Zero Sample Preparation Zero Sample Preparation Zero Sample Preparation Zero Sample Preparation Zero Sample Preparation	Bioanalytics	Obinoscopy	2018-04-15 02:19	5	2018-04-20 16:21	544
Oral Dispersible Tablet BE study USFDA submission Oral Dispersible Tablet BE study USFDA submission	Regulatives / Guidelines	Ramesh Ramalingam	2018-04-13 10:52	1	2018-04-13 21:23	449
Levothyroxine Sample size and study design Levothyroxine Sample size and study design Levothyroxine Sample size and study design Levothyroxine Sample size and study design Levothyroxine Sample size and study design	Power / Sample Size	lakshmiprasad	2018-04-11 15:09	4	2018-04-14 12:55	673
f2 comparison f2 comparison f2 comparison f2 comparison f2 comparison f2 comparison f2 comparison f2 comparison	Dissolution / BCS / IVIVC	jag009	2018-04-10 15:58	7	2018-04-13 07:48	943