Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Cross over BE study with four periods Cross over BE study with four periods	TAC_Sp	2014-04-04 13:39	1	2014-04-04 12:20	3,788
Two Stage Design for EMEA Two Stage Design for EMEA Two Stage Design for EMA [sic] Two Stage Design for EMA [sic]	prashantmohite	2014-03-29 06:39	3	2014-04-01 04:20	5,999
Interim analysis report generation TSD? TSD? TSD procedure R-code for balance R-code for balance Fixed sample size?	Tina	2014-01-02 09:33	6	2014-01-06 12:52	8,736
Acceptance by FDA/CDER Two stage BE design Two stage BE design Two stage BE design Two stage BE design Two stage BE design Two stage BE design EMA vs. rest of the world Two stage BE design — cold water thrown on our head Open your mouth and forcefully spit the water out Change in statistical design Bad idea Bad idea Change to Method B? Change to Method B? Simulations Open your mouth and forcefully spit the water out Reach for the stars Alpha inflation in two stage design Deficiency letters Deficiency letters Simulations Simulations Simulations Simulations Ejaculatio praecox Ejaculatio praecox All effects fixed All effects fixed EMA…	Mahesh	2013-08-06 06:12	29	2013-12-09 11:45	28,280
Difference between two stage and group sequential design Difference between two stage and group sequential design Terminology Terminology	niraj.bhatt	2013-12-04 04:25	3	2013-12-06 05:47	8,710
Potvin’s TSDs in the EU Partial thumbs up to AGES AGES & numeric precision AGES & numeric precision Potvin’s TSDs in the EU Exegesis Potvin’s TSDs in the EU	Helmut	2013-10-30 18:48	6	2013-10-31 17:16	8,401
Potvin’s 2-stage adaptive design Potvin’s 2-stage adaptive design + RSABE/ABEL Potvin’s 2-stage adaptive design + RSABE/ABEL Tough job Tough job C/D for EMA? Good luck! Surprise? Got it. Ages for sims to complete Life belt Life belt Power for Two stage Design Power for Two stage Design Power for Two stage Design “Interim power” “Interim power” Validation of PowerTOST Phoenix/WinNonlin - power Phoenix/WinNonlin - power power	GSD	2012-08-17 20:56	18	2013-10-10 06:36	23,641
Method C’s α ⇒ B	Helmut	2013-08-17 15:49	0		3,290
Parallel Power Problems Parallel Power shifted Doubts explained Formulas Formulas	ElMaestro	2013-02-14 14:46	4	2013-02-15 15:16	7,030
Add-on study data combining procedure Add-on study data combining procedure Add-on study data combining procedure Ref’s for Methods C/D Ref’s for Methods C/D No more add-ons for submissions in Canada	msmnainar	2013-02-14 08:08	5	2013-02-14 12:40	8,262
Brave New World (no pun!) Brave New World (no pun!)	Helmut	2013-01-21 23:06	1	2013-01-22 09:51	5,438
Another Two-Stage ‘idea’ (lengthy) Not a PSRtPH that can be defended Full adaptive without α-spending? Full adaptive with futility rule Full adaptive with futility rule Piece of paper… Piece of paper… Piece of paper…	Helmut	2012-12-01 01:50	7	2012-12-05 18:56	12,243
Potvin – all effects fixed (PHX/WNL vs. SAS, R) Potvin – all effects fixed (PHX/WNL vs. SAS, R) Potvin – all effects fixed (PHX/WNL vs. SAS, R) Potvin – all effects fixed (PHX/WNL vs. SAS, R) Potvin – all effects fixed - SAS Potvin – all effects fixed (PHX/WNL resolved) Potvin – all effects fixed (PHX/WNL resolved) Potvin – all effects fixed (PHX/WNL resolved) Mysterious ways Mysterious ways	Helmut	2012-10-26 19:35	9	2012-11-06 16:06	13,364
Sequence imbalance and 2-stage designs	ElMaestro	2012-10-30 19:44	0		2,459
2-stage maximum likelihood of CV/RMSE, given T/R Not sure whether I understand this Not sure whether I understand this Not sure whether I understand this Not sure whether I understand this Not sure whether I understand this Ach du lieber	ElMaestro	2012-10-22 15:06	6	2012-10-23 18:51	8,199