Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Two PK metrics: Inflation of the Type I Error Two PK metrics: Inflation of the Type I Error? A place to start A place to start? A place to start? Scientific gut feeling Five minutes gone - power.tsd.2m() arose A better place to start. Nope Nope I've meditated hard	Helmut	2017-11-12 11:57	10	2017-11-15 12:15	11,747
Potvin designs w. imbalance - what would you expect? Dropouts in stage 2 Dropouts continued	ElMaestro	2017-08-17 13:02	2	2017-09-19 15:17	8,319
Initial sample size guess for the Potvin methods Initial sample size guess for the Potvin methods Initial sample size guess for the Potvin methods Initial sample size guess for the Potvin methods Initial sample size guess for the Potvin methods Confuse-a-Cat Confuse-a-Cat loop ↔ vectorized ↔ direct loop ↔ vectorized ↔ direct loop ↔ vectorized ↔ direct loop ↔ vectorized ↔ direct The n ext crackpot iteration The n ext crackpot iteration The ultimate crackpot iteration! The ultimate crackpot iteration! The ultimate crackpot iteration! The ultimate crackpot iteration! The ultimate crackpot iteration! The ultimate crackpot iteration! The ultimate crackpot iteration! Suggested code Nitpicker! Nitpicker! Nitpicker! Nitpicker! Nitpicker! Benchmark code Benchmark code	ElMaestro	2017-08-19 15:04	27	2017-08-22 23:48	31,046
Potvin C in the EU Potvin C in the EU Potvin C in the EU 2 Groups model FDA 2 Groups model FDA Group effects obsolete? Group effects FDA/EMA Group effects FDA/EMA Group effects FDA/EMA Group effects EMA Group effects EMA Group effects EMA Group effects EMA Group effects EMA Group effects EMA Fixed effects model with Group term Fixed effects model: changing the F, p values Fixed effects model: changing the F, p values Fixed effects model: changing the F, p values Holy War of type III Significance of Group effect in Russia: why the type III is so 'important' Fixed effects model: changing the F, p values FDA group model in R FDA group model in R FDA group model in R FDA group model in R FDA group model in R Fixed effects model with Group term Group effects FDA/EMA Group effects FDA/EMA 2 Groups model FDA Homework	Helmut	2013-04-16 17:40	31	2017-06-03 12:57	49,921
Data for 2nd stage of Potvin’s designs Data for 2nd stage of Potvin’s designs Data for 2nd stage of Potvin’s designs GMR = fixed! “Type 1” slightly higher power than “Type 2” for the same adj. α “Type 1” slightly higher power than “Type 2” for the same adj. α Terminology Terminology Which GMR to plug in Which GMR to plug in Which GMR to plug in Validated frameworks; observed GMR not relevant Validated frameworks; observed GMR not relevant GMR, theta 0 and that all GMR, theta 0 and that all GMR, theta 0 and that all GMR, theta0 and that all GMR, theta0 and that all “Type 1” slightly higher power than “Type 2” for the same adj. α	BE-proff	2017-02-18 06:40	18	2017-03-09 17:01	16,158
Impact of minimum stage 2 sample size on the Type I Error Impact of minimum stage 2 sample size on the Type I Error Impact of minimum stage 2 sample size on the TIE: example Impact of minimum stage 2 sample size on the TIE: example Impact of minimum stage 2 sample size on the TIE: example Impact of minimum stage 2 sample size on the TIE: example Bingo!	Helmut	2016-12-30 01:22	6	2016-12-30 18:00	8,358
Inflation of the TIE with Xu’s ‘Method F’? Inflation of the TIE with Xu’s ‘Method F’? Inflation of the TIE with Xu’s ‘Method F’?	Helmut	2016-12-25 01:49	2	2016-12-27 10:43	4,769
Replicated 4×2 and two-stage-design, in the same protocol Replicated 4×2 and two-stage-design, in the same protocol Science fiction Science fiction Science fiction furthermore Still SF Still SF Still SF Still SF Still SF Still SF Still SF mindblowing Natural constant as usual; not for reference-scaling Consistency	Mauricio Sampaio	2015-04-06 08:37	14	2016-10-11 09:25	19,447
TSD: CIs for different analytes and metrics	mittyri	2016-06-04 21:39	0		3,416
The EMA’s BSWP’s opinon The EMA’s BSWP’s opinon Control of the TIE (empiric via simulations vs. proof) To whom it may concern To whom it may concern Opinon? Obsession? Obsession? 0.0501 not acceptable OT: Guernsey McPearson's Drug Development Dictionary OT: Comparison OT: Comparison	Helmut	2016-03-04 15:37	11	2016-06-02 14:42	12,822
Adaptive TSD vs. “classical” GSD Adaptive TSD vs. “classical” GSD “classical” GSD - E[n] Apples are pears by comparing the weight Apples are pears by comparing the weight Apples are pears by comparing the weight Oranges Adaptive TSD vs. “classical” GSD Adaptive TSD vs. “classical” GSD “classical” GSD alpha's N sufficiently large‽ An other one with 0.0304 An other one with 0.0304 Adaptive TSD vs. “classical” GSD	Helmut	2015-11-27 19:05	13	2016-01-10 11:43	16,456
Letteritis: Method E & F	d_labes	2015-12-17 14:27	0		4,294
futility design futility design OT futility design α [0, 0.05] futility design = SSR ? futility design = SSR ? OT dark universe	Ghannam86	2015-12-16 23:43	7	2015-12-17 11:52	8,937
Sequential trial with B method of Potvin Sequential trial with B method of Potvin Sequential trial with B method of Potvin Sequential trial with B method of Potvin Power to the people Power to the people Software? Ethics beyond statistics… Subtraction of a df df = df-1 Potvin B: α 0.0294 in both stages Potvin B: α 0.0294 in both stages	john john	2015-10-01 17:44	10	2015-10-23 10:04	13,494
BA/BE Studies for Early Termination BA/BE Studies for Early Termination Dose subjects but not using them IMHO, that’s a TSD…	balakotu	2015-09-22 13:05	3	2015-09-22 11:58	6,628