Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
2-Stage design Sequential design, maximum sample size in stage 2 Sequential design, maximum sample size in stage 2 Well roared, lion	balakotu	2012-06-21 08:28	3	2012-06-22 06:45	7,447
Adaptive BE: concepts Adaptive BE: concepts Adaptive BE: concepts	martin	2012-07-11 20:31	2	2012-07-12 11:36	4,547
Sequential designs, draft FDA guidance Loteprednol What the heck? some unofficial opinion with this regard in Europe Great! Great! Potvin & Montague not acceptable at all?! Powerless Potvin & Montague? Example w.o. intermediate power Example w.o. intermediate power Sims w.o. intermediate power Potvin & Montague not acceptable at all?! Sims?	ElMaestro	2012-07-03 18:33	11	2012-07-26 14:20	23,811
two-stage design power 90% second stage two-stage design power 90% second stage two-stage design power 90% second stage two-stage design power 90% second stage two-stage design power 90% in sample size adaption two-stage design power 90% in sample size adaption two-stage design power 90% in sample size adaption two-stage design power 90% in sample size adaption Are simulations sufficient? …lenghty post! adjusted alpha = 0.045 adjusted alpha = 0.038 adjusted alpha by sims? Yeah but, no but, yeah but, no but… Yeah but, no but ... Yeah but, no but ...	Yvonne	2012-08-02 09:50	14	2012-08-07 13:14	16,308
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	8,172
Sequence imbalance and 2-stage designs	ElMaestro	2012-10-30 19:44	0		2,450
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	13,329
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	12,213
Brave New World (no pun!) Brave New World (no pun!)	Helmut	2013-01-21 23:06	1	2013-01-22 09:51	5,427
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	8,235
Parallel Power Problems Parallel Power shifted Doubts explained Formulas Formulas	ElMaestro	2013-02-14 14:46	4	2013-02-15 15:16	7,003
Method C’s α ⇒ B	Helmut	2013-08-17 15:49	0		3,284
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	23,579
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	8,378
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	8,690