Bioequivalence and Bioavailability Forum • Search

294 matches found.

Simulation-based 2×2×2 TSDs – a deep dive Helmut 2024-09-03 15:18 [Two-Stage / GS Designs]
Pooling of studies? Helmut 2024-09-02 15:55 [Regulatives / Guidelines]
Parallel (replicate?) Helmut 2024-08-28 12:54 [Two-Stage / GS Designs]
A rant Achievwin 2024-08-28 04:16 [Two-Stage / GS Designs]
A rant Helmut 2024-08-26 14:52 [Two-Stage / GS Designs]
Parallel design: Only simulation-based methods so far Helmut 2024-04-04 22:16 [Two-Stage / GS Designs]
Two-Stage Sequential Potvin Designs ElMaestro 2024-03-10 21:18 [Two-Stage / GS Designs]
Two-Stage Sequential Potvin Designs BEQool 2024-03-10 11:11 [Two-Stage / GS Designs]
Two-Stage Sequential Potvin Designs ElMaestro 2024-03-05 21:51 [Two-Stage / GS Designs]
Simulations highly recommended Helmut 2024-01-05 13:40 [Two-Stage / GS Designs]
Parallel Group Adaptive Designs Achievwin 2024-01-05 12:53 [Two-Stage / GS Designs]
TSD? Helmut 2024-01-01 14:50 [Power / Sample Size]
Problematic T/R-ratio… Helmut 2023-12-27 14:27 [Power / Sample Size]
TSD useful at all? Helmut 2023-12-26 13:50 [Two-Stage / GS Designs]
Strong Type I Error control + CI: Not yet… Helmut 2023-12-22 13:01 [Two-Stage / GS Designs]
Parallel Group Adaptive Designs Alex 2023-12-22 11:08 [Two-Stage / GS Designs]
Exploring package adaptIVPT, function rss() Helmut 2023-12-20 14:27 [Two-Stage / GS Designs]
Likely it does not work (potentially inflated Type I Error) Helmut 2023-12-19 12:10 [Two-Stage / GS Designs]
Adaptive Design for the FDA’s RSABE? Helmut 2023-12-18 12:20 [Two-Stage / GS Designs]
Replicate Design ≠ Higher-Order Crossover Helmut 2023-03-14 11:37 [Design Issues]
From Potvin C to Inverse Normal: history (and outlook?) Helmut 2022-06-27 20:54 [Two-Stage / GS Designs]
Parallel design: Maybe (‼) in exceptional cases Helmut 2022-06-15 16:08 [RSABE / ABEL]
Acceptance limits for tmax Helmut 2022-06-07 19:32 [Nonparametrics]
Adjusting weight to reflect group differences in Model Helmut 2022-03-30 13:07 [General Statistics]
Simulation-based methods acceptable for the FDA Helmut 2022-03-21 14:32 [Regulatives / Guidelines]
Old references… Helmut 2021-09-14 19:46 [Power / Sample Size]
Forget simulation-based TSDs for 2×2×2 in Europe Helmut 2021-07-19 19:22 [Two-Stage / GS Designs]
Two-stage design & RSABE: Forget it! Helmut 2021-05-19 22:40 [Design Issues]
Two-stage design ❌ RSABE Achievwin 2021-05-19 21:08 [Design Issues]
Two-stage replicate design studies for RSABE Achievwin 2021-05-14 21:20 [Design Issues]
Replicate designs based on information of 2×2×2 design Helmut 2021-02-20 15:50 [Design Issues]
Bioequivalence of mirabegron 50 mg extended release Tablet Ibrahim Komeil 2021-02-20 12:36 [Design Issues]
WHO frequent deficiencies in protocols and reports Helmut 2020-12-22 20:00 [BE/BA News]
BABE 101 (lenghty and spiced with PK) Helmut 2020-07-23 18:02 [Software]
EMA: TSDs Helmut 2020-06-23 20:22 [Two-Stage / GS Designs]
Two-stage design Regulatory Mikkabel 2020-06-23 19:42 [Two-Stage / GS Designs]
Two-stage BE study Achievwin 2020-06-17 17:12 [Design Issues]
Options Helmut 2020-05-02 13:35 [Study Assessment]
Fast & fed in one study (alternative) Helmut 2020-03-04 15:15 [Design Issues]
Explained crap remains crap Helmut 2020-02-17 13:49 [Two-Stage / GS Designs]