Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
EMA replicate surprise EMA replicate surprise Big bäng CV Big bäng CV Period DFs Period DFs Period DFs Period DFs Period DFs Lessons learned? Lessons learned? Lessons learned? Period DFs - EMA code literally in R Period DFs - EMA code literally in R call for expert’s opinions call for expert’s opinions The finance sector	d_labes	2011-08-23 13:01	16	2011-11-02 08:48	10,072
Required BE studies for sevelamer for EU Required BE studies for sevelamer for EU Required BE studies for sevelamer for EU Required BE studies for sevelamer for EU	govardhanpillari	2010-07-01 13:55	3	2011-10-27 09:18	6,571
Therapeutic Equivalence Therapeutic Equivalence Therapeutic Equivalence Therapeutic Equivalence Therapeutic Equivalence Therapeutic Equivalence Therapeutic Equivalence Therapeutic Equivalence Therapeutic Equivalence Therapeutic Equivalence Going Off-Topic	maulik963	2011-10-19 11:45	10	2011-10-24 20:15	8,491
Waiver of lower strength Waiver of lower strength Waiver of lower strength	Averroes	2011-10-20 14:45	2	2011-10-24 15:18	4,364
Meal, Posture, Age Impact on BE and Study Requirement BE model: healthy subjects	Alpesh Ramani	2011-10-18 14:12	1	2011-10-18 13:57	2,656
parallel study design issue Search! parallel study design issue	pash413	2011-10-15 15:31	2	2011-10-15 15:20	2,949
Least Square Means (LSM) for unequal sequence Least Square Means (LSM) for unequal sequence Least Square Means (LSM) for unequal sequence Least Square Means (LSM) for unequal sequence Least Square Means (LSM) for unequal sequence Least Square Means (LSM) for unequal sequence Least Square Means (LSM) for unequal sequence Weighted Means? LSM for unbalanced sequences -SAS- LSM for unbalanced sequences -SAS- SE for unbalanced sequences SAS vs. WinNonlin LS Means mean? LS Means mean? PHX/WNL vs. SAS PHX/WNL vs. SAS Proc Mixed PHX/WNL vs. SAS Proc Mixed PHX/WNL vs. SAS Proc Mixed Real mixed effects in WNL, SAS, GLM or Mixed (1) Real mixed effects in WNL, SAS, GLM or Mixed (2) Real mixed effects in WNL, SAS, GLM or Mixed (3) Must admit I am lost Must admit I am lost Must admit I am lost - edited	yicaoting	2011-10-03 14:37	22	2011-10-14 11:23	19,462
Widened acceptance range w. a 2,2,2-study? Widened acceptance range w. a 2,2,2-study? Widened acceptance range w. a 2,2,2-study? Quot licet Iovi, non licet bovi Cmax of interest? CI outside 80.00%–125.00% CI outside 80.00%–125.00%, who cares? Common sense rulez?!	ElMaestro	2011-10-09 13:44	7	2011-10-11 14:27	5,992
"Primary concern" for regulators. Warning: excentric post "Secondary concern" for regulators? "Not our problem" for regulators ?	ElMaestro	2011-10-07 16:37	2	2011-10-07 16:18	4,796
Procurement of Reference formulations Procurement of Reference formulations	yashpharma	2011-09-28 05:01	1	2011-09-29 04:30	2,449
DCGI or DGFT permission for Importing of Plasma samples DCGI or DGFT permission for Importing of Plasma samples DCGI or DGFT permission for Importing of Plasma samples DCGI or DGFT permission for Importing of Plasma samples DCGI or DGFT permission for Importing of Plasma samples DCGI or DGFT permission for Importing of Plasma samples DCGI or DGFT permission for Importing of Plasma samples DCGI or DGFT permission for Importing of Plasma samples	Support	2011-01-17 06:47	7	2011-09-27 10:08	6,232
Dry Powder for Inhaler: BE or CT? Dry Powder for Inhaler: BE or CT?	luvblooms	2011-09-26 13:27	1	2011-09-26 11:48	7,344
BE Information	A-M-R	2011-09-25 15:01	0		1,572
EMA Guideline on Bioanalytical Method Validation EMA Guideline on Bioanalytical Method Validation	sevim	2011-09-19 09:04	1	2011-09-19 18:33	3,432
TGA Guidance TGA Guidance	Cmax	2011-09-16 19:26	1	2011-09-16 17:42	2,921