Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		149,874
Achievement of Steady State Achievement of Steady State: Visual inspection & common sense Achievement of Steady State: Visual inspection & common sense Threshold of % change? Threshold of % change?	General Statistics	arl_stat	2021-07-31 07:42	4	2021-10-17 12:16	1,546
Everything you didn't know about bacterial genetics	Off Topic	ElMaestro	2021-10-17 08:52	0		42
statistical test for Bioavailability studies One-sample t-test	General Statistics	Loky do	2021-10-13 15:06	1	2021-10-14 10:59	172
Ibuprofen product-specific bioequivalence guidance EMA Ibuprofen product-specific bioequivalence guidance EMA Undeliverable e-mail Enantioselective assay – really? Enantioselective assay – really?	Regulatives / Guidelines	qualityassurance	2021-09-26 07:45	4	2021-10-12 15:15	478
Two Stage Desing: ANOVA Potvin et al: effects in stage 2 Potvin et al: effects in stage 2 Forget simulation-based TSDs for 2×2×2 in Europe TSD statistical model - with multiple sites TSD statistical model - with multiple sites TSD statistical model - with multiple sites TSD statistical model - with multiple sites	Two-Stage / GS Designs	earlybird	2009-10-16 11:25	7	2021-10-12 11:27	7,194
IVIVC Studies IVIVC Studies IVIVC Studies IVIVC Studies Wagner-Nelson, Loo-Riegelman Wagner-Nelson, Loo-Riegelman Deconvolution Numerical Deconvolution Numerical Deconvolution Numerical Deconvolution Daniel still active in the Forum? Daniel still active in the Forum? Wagner-Nelson Wagner-Nelson IVIVC IVIVC / Mapping IVIVC / Mapping IVIVC / Software IVIVC / Software IVIVC / Software at least 3 formulations for IVIVC at least 3 formulations for IVIVC at least 1 formulation for Level A at least 1 formulation for Level A IVIVC / Software IVIVC set up/ requirements	Dissolution / BCS / IVIVC	MGR	2007-02-02 10:10	25	2021-10-08 09:07	35,798
AUC · k for variable inter-occasion CL AUC · k for variable inter-occasion CL Changing the regulations: Hope dies last. AUC * k AUC * k AUC * k Ratio/product of two lognormals Not for HVDPs? what about recyclers? Oh dear! Changing the regulations: Hope dies last.	NCA / SHAM	Helmut	2021-09-30 23:31	10	2021-10-04 16:10	655
dead / void volume dead / void volume	Bioanalytics	Bioanalytical	2021-10-03 16:28	1	2021-10-03 21:14	265
Inter-subject variability in Full replicate design Inter-subject variability in Full replicate design Inter-subject variability in Full replicate design	RSABE / ABEL	MGR	2021-09-30 07:35	2	2021-09-30 15:25	350
4th GBHI report	BE/BA News	Helmut	2021-09-29 18:03	0		205
EU: Fed or fasting conditions for BE study EU: Fed state according to the reference’s SmPC EU: Fed state according to the reference’s SmPC	Design Issues	Farmacevt	2021-09-24 15:47	2	2021-09-27 21:44	370
dropouts in replicate studies dropouts in replicate studies The EMA’s ‘Data set I’ is incomplete The EMA’s ‘Data set I’ is incomplete	Regulatives / Guidelines	Loky do	2021-09-23 14:54	3	2021-09-25 22:01	486
Sevelamer Carbonate In vitro binding study for EMA submission	Regulatives / Guidelines	jansari	2021-09-24 19:03	0		240
RLD identification in EU region in view of Brexit RLD identification in EU region in view of Brexit MHRA: No ‘own’ BE GL? RLD identification in EU region in view of Brexit RLD identification in EU region in view of Brexit No ‘RLD’ in the EEA	Regulatives / Guidelines	shahajan baig	2021-08-31 14:49	5	2021-09-24 15:36	841