Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Simulation-based 2×2×2 TSDs – a deep dive	Helmut	2024-09-03 13:18	0		2,895
A rant A rant Parallel (replicate?)	Helmut	2024-08-26 12:52	2	2024-08-28 10:54	4,843
Parallel Group Adaptive Designs Strong Type I Error control + CI: Not yet… Strong Type I Error control + CI: Not yet… Strong Type I Error control + CI: Not yet… Strong Type I Error control + CI: Not yet… Parallel design: Only simulation-based methods so far Parallel design: Only simulation-based methods so far Parallel Group Adaptive Designs Simulations highly recommended Simulations highly recommended Simulations mandatory Simulations mandatory Reviews are confidential Reviews are confidential Not accepted and for a reason… Quod licet Iovi Non licet bovi Non licet bovi Quod licet bove?	Alex	2023-12-22 10:08	18	2024-04-15 21:46	14,853
Two-Stage Sequential Potvin Designs TSD, GSD, Add-Ons, etc. Two-Stage Sequential Potvin Designs Two-Stage Sequential Potvin Designs Two-Stage Sequential Potvin Designs Too coarse grid? Too coarse grid? Balance… Two-Stage Sequential Potvin Designs	BEQool	2024-03-04 08:45	8	2024-03-12 11:40	7,455
Adaptive Design for the FDA’s RSABE? Likely it does not work (potentially inflated Type I Error) Exploring package adaptIVPT, function rss() Extreme test case Extreme GMR PE outside {0.80, 1.25} not possible PE outside {0.80, 1.25} not possible Forget rss() Forget rss() TSD useful at all?	Helmut	2023-12-18 11:20	9	2023-12-26 12:50	10,623
T1E after 1st stage in Power2Stage T1E after 1st stage in TSDs T1E after 1st stage in TSDs T1E after 1st stage in TSDs Potvin C consequences Potvin C consequences Potvin C consequences Potvin C consequences from Potvin C to Inverse Normal From Potvin C to Inverse Normal: history (and outlook?) Potvin C consequences true CV ≠ observed CV T1E after 1st stage in Power2Stage T1E after 1st stage in Power2Stage T1E after 1st stage in Power2Stage	mittyri	2022-06-24 13:43	14	2022-06-27 16:54	9,078
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 09:27	14,576
Two-stage design Regulatory EMA: TSDs	Mikkabel	2020-06-23 17:42	1	2020-06-23 16:22	5,179
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 13:16	14,887
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 11:58	10,378
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 14:15	20,748
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 20:56	6,290
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	2019-06-05 22:55	21,699
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 08:52	26,271
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 12:00	9,980