Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
Appropriate wording for a protocol Appropriate wording for a protocol Appropriate wording for a protocol Appropriate wording for a protocol Which country? Which country? EEU-rules, TSD-methods (lengthy answer) EEU-rules, TSD-methods (lengthy question)	Elena777	2019-09-09 19:34	7	2019-09-14 14:56	380
Two-Stage Design for FDC No simple way out the more complicated the more interesting	Astea	2019-06-06 01:24	2	2019-06-09 22:56	780
2-stage design with interim sample size estimation 2-stage design with interim sample size estimation Null = bioINequivalence 2-stage design with interim sample size estimation 2-stage design with interim sample size estimation Blind or not, Indecisions or Decisions Blind or not, Indecisions or Decisions Blind ? Blind ? Blind 2Stage Blind 2Stage Blind 2Stage and an elephant Which elephant? Blind interim in parallel design? Blind men The Blind Leading the Blind	d_labes	2010-10-05 15:09	15	2019-06-06 00:55	9,802
Finally: Exact TSD methods for 2×2 crossover designs Exact TSD methods: Example Finally: Exact TSD methods for 2×2 crossover designs Flow chart (without details) naive questions regarding new functions in Power2Stage Some answers Some more "answers" clarification regarding user Power2Stage guides Technicality: Weigths for the inverse normal approach Selection of w and w* Selection of w and w* Now what? w & w* examples Now what? w & w* examples Now what? w & w* examples Now what? w & w* examples a bug in interim.tsd.in()? a bug in interim.tsd.in()? Nonbinding futility rule Bad weather? NLYW? Nonbinding futility rule Nonbinding futility rule Nonbinding futility rule Binding / Nonbinding futility rule - alpha control Binding / Nonbinding futility rule - alpha control	Helmut	2018-04-21 17:17	24	2019-03-30 09:52	7,749
Two-stage design and 'forced bioequivalence' Two-stage design and 'forced bioequivalence' Two-stage design and 'forced bioequivalence' But what is the real problem? But what is the real problem? But what is the real problem? But what is the real problem? But what is the real problem? U as a futility criterion	Mikalai	2018-06-06 08:28	8	2018-06-08 14:00	2,273
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 13:15	5,624
Potvin designs w. imbalance - what would you expect? Dropouts in stage 2 Dropouts continued	ElMaestro	2017-08-17 13:02	2	2017-09-19 17:17	4,248
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	2017-08-23 01:48	23,641
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 14:57	34,408
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 18:01	10,182
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 19:00	4,339
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 11:43	2,348
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 11:25	14,665
TSD: CIs for different analytes and metrics	mittyri	2016-06-04 21:39	0		1,887
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 16:42	8,923