Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
PuMas - introducing Julia in pharmacometrics PuMas - introducing Julia in pharmacometrics	Software	yjlee168	2019-11-06 23:44	1	2019-11-07 10:28	202
Least square mean calculation for the fully replicate design Very, very strange! Very, very strange! Very, very strange! Very, very strange! G matrix Inner workings of REML Even in ANOVA… Even in 2x2... trying to understand emmeans Least square mean calculation for the fully replicate design	General Statistics	Jaimik Patel	2019-10-31 11:19	10	2019-11-03 01:38	605
Big Pharma strikes back with data secrecy Big Pharma strikes back with data secrecy OOT: Sci-Hub OOT: Sci-Hub OOT: ICBM OOT: ICBM	Off Topic	mittyri	2019-10-28 10:13	5	2019-10-30 21:42	484
standby and retention samples standby and retention samples standby and retention samples Reserve samples? Spare subjects? Spare subjects? Spare subjects? standby and retention samples	Regulatives / Guidelines	zeynep	2019-10-24 12:22	7	2019-10-30 11:31	532
Dissolution Testing Requirement - ANDA	Dissolution / BCS / IVIVC	jag009	2019-10-30 02:29	0		210
If method doesn't exist in FDA Disso Database USP should be fine USP should be fine	Dissolution / BCS / IVIVC	jag009	2019-10-24 20:54	2	2019-10-30 02:23	364
SUPAC level 3 changes for MR formulations SUPAC level 3 changes for MR formulations SUPAC level 3 changes for MR formulations SUPAC level 3 changes for MR formulations	Regulatives / Guidelines	Mithu	2019-09-30 07:42	3	2019-10-24 05:34	600
12 units from 12 different bottles should be used - Dissolution for Suspensions 12 units from 12 different bottles should be used - Dissolution for Suspensions	Regulatives / Guidelines	bharathi	2019-09-26 12:20	1	2019-10-22 21:29	1,199
Emesis criteria for study comparing IR vs. MR formulations Emesis criteria for study comparing IR vs. MR formulations Emesis criteria for study comparing IR vs. MR formulations Almost OT Almost OT Completely OT median Tmax median Tmax median Tmax	Study Performance	Rock	2019-10-16 13:38	8	2019-10-22 21:26	730
EU, method C preference On the contrary, my dear Dr Watson! On the contrary, my dear Dr Watson! On the contrary, my dear Dr Watson! On the contrary, my dear Dr Watson! On the contrary, my dear Dr Watson! On the contrary, my dear Dr Watson! EU: simulation-based methods in agony EU: ABEL TIE?? Reference-scaling: only simulations possible	Two-Stage / GS Designs	ElMaestro	2019-10-11 10:25	9	2019-10-20 13:58	949
Metformin and linaglibtin film coated tablet	Bioanalytics	Ibrahim Komeil	2019-10-19 02:18	0		316
Bicalutamide having Long Half Life Bicalutamide: Crossover not realistic Bicalutamide: Crossover not realistic	Design Issues	udayk	2019-10-04 12:06	2	2019-10-10 09:10	539
how to get t50%GIR-AUC(0-8h) in winnolin? POT-50 POT-50 AUC-apical? AUC-apical? Define your terms! Define your terms! Define your terms!	Software	Aisha.ma	2019-10-07 07:46	7	2019-10-08 10:51	760
EMA: Mahalanobis distance is dead... EMA: Mahalanobis distance is dead... Is ƒ2 dead as well – always bootstrapping? Is ƒ2 dead as well – always bootstrapping? Ahem – number of units? Ahem – number of units? Ahem – number of units?	Dissolution / BCS / IVIVC	Helmut	2018-11-09 18:01	6	2019-10-07 19:11	1,915
Sample size and randomization plan Sample size and randomization plan	Power / Sample Size	Ibrahim Komeil	2019-10-06 11:56	1	2019-10-06 18:00	494