Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
BE criteria of extended release and enteric coated formulation for Canada Do your homework first Do your homework first	khageswara Rao	2021-12-13 11:07	2	2021-12-17 10:19	4,220
Primary pharmacodynamic bioequivalence Primary pharmacodynamic bioequivalence Primary pharmacodynamic bioequivalence	ceylan	2021-11-19 15:46	2	2021-11-20 22:14	4,423
Outliers - this one is for you, zizou	ElMaestro	2021-10-31 08:01	0		2,788
Acceptance criteria of analytical run Acceptance criteria of analytical run Acceptance criteria of analytical run Acceptance criteria of analytical run Acceptance criteria of analytical run Acceptance criteria of analytical run Acceptance criteria of analytical run ’Percentage’ of few values ’Percentage’ of few values	qualityassurance	2021-10-18 07:00	8	2021-10-21 14:57	7,079
Ibuprofen product-specific bioequivalence guidance EMA Ibuprofen product-specific bioequivalence guidance EMA Undeliverable e-mail Enantioselective assay – really? Enantioselective assay – really?	qualityassurance	2021-09-26 07:45	4	2021-10-12 13:15	6,279
dropouts in replicate studies dropouts in replicate studies The EMA’s ‘Data set I’ is incomplete The EMA’s ‘Data set I’ is incomplete	Loky do	2021-09-23 14:54	3	2021-09-25 20:01	5,429
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	shahajan baig	2021-08-31 14:49	5	2021-09-24 13:36	7,293
Desperate reader Desperate reader Misunderstanding? Misunderstanding? Here we are Papers FDA: PROC MIXED (‼) for ABE FDA: PROC MIXED (‼) for ABE FDA: PROC MIXED (‼) for ABE	Helmut	2021-08-27 15:51	8	2021-09-17 15:11	9,466
Clarity required Follow the guidance	suchit_bhavsar	2021-08-27 05:02	1	2021-08-27 08:31	5,086
Bootstrapping methodology in Bioequivalence	Achievwin	2021-08-17 22:30	0		2,714
What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG No acceptance criteria widening for AUC in Europe No reference-scaling for NTIDs What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG	prasad.v	2021-07-29 10:33	3	2021-08-06 06:47	5,789
“Fixed Effects, Rather Than Random Effects…” Very nice! Very nice! Narrower CI with LM?	ElMaestro	2021-08-04 08:18	3	2021-08-04 13:22	6,153
statistical approaches for dose-finding PK studies statistical approaches for dose-finding PK studies	Sridhar.E	2021-07-13 11:04	1	2021-07-17 17:04	4,412
Bracketing approach for multiple strenght product EMA Bracketing approach for multiple strenght product EMA	jag009	2021-07-06 19:19	1	2021-07-17 09:44	3,770
Ethnicity of Indian population Ethnicity of Indian population Ethnicity of Indian population Ethnicity of Indian population	Vishal S	2021-06-22 07:25	3	2021-07-06 14:21	4,286