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		34,027
Freshly prepared Vs freshly spiked	Bioanalytics	Ramesh	2018-06-20 17:14	0		62
FDA deficiencies FDA deficiencies File update ? File update ? File update ?	GxP / QC / QA	Helmut	2018-06-20 13:45	4	2018-06-20 15:59	125
Bio-equivalence of IR Tablet against ER Tablet	Design Issues	Jasim Uddin	2018-06-20 13:29	0		55
Report Preparation	Regulatives / Guidelines	lakshmiprasad	2018-06-20 05:56	0		85
Exclusion of PK parameters where less than 3 quantifiable concentrations Reliable estimates?	NCA / SHAM	Babe_Ruth	2018-06-19 18:13	1	2018-06-20 01:12	146
Test statistic about Tmax Wilcoxon signed rank test Wilcoxon-Mann-Whitney! Wilcoxon-Mann-Whitney! Wilcoxon-Mann-Whitney PMID choice of result No significance testing in BE	Nonparametrics	libaiyi	2018-06-19 08:15	6	2018-06-20 11:24	281
Phoenix 8.1	Software	Helmut	2018-06-19 01:43	0		102
Updated TPD BE guidances Updated TPD BE guidances	BE/BA News	BRB	2018-06-18 22:53	1	2018-06-19 01:32	168
> 5% of Cmax for endogenous molecule? Any own thoughts?	Regulatives / Guidelines	Ramesh Ramalingam	2018-06-18 08:00	1	2018-06-18 10:59	198
Installing Bioconductor packages	R for BE/BA	Helmut	2018-06-17 15:36	0		116
the difference between winnonlin and nonmem Nonlinear mixed effects models	Software	libaiyi	2018-06-14 09:32	1	2018-06-14 13:03	246
how to calculate MSEw and MSEb Get software! Get software! Within-subject variability: Property of the drug (& formulation) Within-subject variability: Property of the drug (& formulation)	General Statistics	verstc	2018-06-12 02:23	4	2018-06-19 10:20	407
Virtual Bioequivalence: a myth or coming reality? Virtual Bioequivalence: a myth or coming reality?	Dissolution / BCS / IVIVC	mittyri	2018-06-09 22:39	1	2018-06-13 02:40	342
Calculate the BE limits for HVDPs based on EMA Calculate the BE limits for HVDPs based on EMA (Expanded) BE limits, EMA-style (Expanded) BE limits, EMA-style CFDA: Yet another story? CFDA: Yet another story? CFDA: Draft guidance? CFDA: Draft guidance? Hypotheses generated “in face of the data” Hypotheses generated “in face of the data”	RSABE / ABEL	libaiyi	2018-06-08 11:41	9	2018-06-14 03:46	686
BE study stratified per body weight group BE study stratified per body weight group BE study stratified per body weight group BE study stratified per body weight group	General Statistics	martin	2018-06-08 09:15	3	2018-06-08 21:11	304