Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
Two Stage Desing: ANOVA Potvin et al: effects in stage 2 Potvin et al: effects in stage 2 Forget simulation-based TSDs for 2×2×2 in Europe TSD statistical model - with multiple sites TSD statistical model - with multiple sites TSD statistical model - with multiple sites TSD statistical model - with multiple sites	earlybird	2009-10-16 11:25	7	2021-10-12 11:27	7,506
Two-stage design Regulatory EMA: TSDs	Mikkabel	2020-06-23 17:42	1	2020-06-23 18:22	1,222
ANVISA guidelines for two-stage design Brainless copy-and-paste-devil Brainless copy-and-paste-devil ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design crap crap crap crap Explained crap remains crap Proposed changes Proposed changes	Mauricio Sampaio	2020-02-11 20:52	15	2020-02-17 14:16	5,364
EU, method C preference On the contrary, my dear Dr. Watson! On the contrary, my dear Dr. Watson! On the contrary, my dear Dr. Watson! On the contrary, my dear Dr. Watson! On the contrary, my dear Dr. Watson! On the contrary, my dear Dr. Watson! EU: simulation-based methods in agony EU: ABEL TIE?? Reference-scaling: only simulations possible	ElMaestro	2019-10-11 10:25	9	2019-10-20 13:58	4,005
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) n2 based on PK metric with higher CV Q&A ref The omniscient oracle has spoken The omniscient oracle has spoken OT: Булга́ков n2 based on PK metric with higher CV AUC passes with 0.05 and Cmax with 0.0294 AUC passes with 0.05 and Cmax with 0.0294 Hybrid B/C AUC passes with 0.05 and Cmax with 0.0294 Use data of all dosed subjects Use data of all dosed subjects ‘Method C’ ⇒ risky EEU-rules, TSD-methods (lengthy question) apple tree for two-stage overripe apples override apples	Elena777	2019-09-09 19:34	24	2019-09-19 16:15	7,429
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	2,351
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	13,588
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	16,290
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	4,514
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	8,605
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	5,797
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	27,247
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	42,835
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	12,476
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	5,878