A simple two-stage design for quantitative responses with application to a study in diabetic neuropathic pain

2008 ◽  
Vol 8 (2) ◽  
pp. 125-135 ◽  
Author(s):  
John Whitehead ◽  
Elsa Valdés-Márquez ◽  
Agneta Lissmats
Keyword(s):  
Neuropathic Pain ◽  
Diabetic Neuropathic Pain ◽  
Two Stage ◽  
Stage Design ◽  
Two Stage Design

Tubular electrostatic precipitators of two-stage design

1981 ◽  
Vol 6 (1-6) ◽  
pp. 239-244 ◽  
Author(s):  
Harish S. Surati ◽  
Michael R. Beltran ◽  
Isaac Raigorodsky
Keyword(s):  
Two Stage ◽  
Stage Design ◽  
Electrostatic Precipitators ◽  
Two Stage Design

scholarly journals Bayesian Two-Stage Adaptive Design in Bioequivalence

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Shengjie Liu ◽  
Jun Gao ◽  
Yuling Zheng ◽  
Lei Huang ◽  
Fangrong Yan
Keyword(s):  
Statistical Power ◽  
Adaptive Design ◽  
Type I Error ◽  
Probability Model ◽  
Type I ◽  
Two Stage ◽  
Stage Design ◽  
Estimation Strategy ◽  
Drug Products ◽  
Two Stage Design

AbstractBioequivalence (BE) studies are an integral component of new drug development process, and play an important role in approval and marketing of generic drug products. However, existing design and evaluation methods are basically under the framework of frequentist theory, while few implements Bayesian ideas. Based on the bioequivalence predictive probability model and sample re-estimation strategy, we propose a new Bayesian two-stage adaptive design and explore its application in bioequivalence testing. The new design differs from existing two-stage design (such as Potvin’s method B, C) in the following aspects. First, it not only incorporates historical information and expert information, but further combines experimental data flexibly to aid decision-making. Secondly, its sample re-estimation strategy is based on the ratio of the information in interim analysis to total information, which is simpler in calculation than the Potvin’s method. Simulation results manifested that the two-stage design can be combined with various stop boundary functions, and the results are different. Moreover, the proposed method saves sample size compared to the Potvin’s method under the conditions that type I error rate is below 0.05 and statistical power reaches 80 %.

scholarly journals 10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented?

2020 ◽  
Vol 37 (7) ◽  
Author(s):  
Michał Kaza ◽  
Alexander Sokolovskyi ◽  
Piotr J. Rudzki
Keyword(s):  
Bioequivalence Study ◽  
European Medicines Agency ◽  
Two Stage ◽  
Stage Design ◽  
10Th Anniversary ◽  
The Public ◽  
Advantages And Disadvantages ◽  
Pivotal Study ◽  
Two Stage Design

Abstract Purpose In 2010 the European Medicines Agency allowed a two-stage design in bioequivalence studies. However, in the public domain there are mainly articles describing the theoretical and statistical base for the application of the two-stage design. One of the reasons seems to be the lack of practical guidance for the Sponsors on when and how the two-stage design can be beneficial in bioequivalence studies. Methods Different variants with positive and negative outcomes have been evaluated, including a pivotal study, pilot + pivotal study and two-stage study. The scientific perspective on the two-stage bioequivalence study has been confronted with the industrial one. Results Key information needed to conduct a bioequivalence study – such as in vitro data and pharmacokinetics – have been listed and organized into a decision scheme. Advantages and disadvantages of the two-stage design have been summarized. Conclusion The use of the two-stage design in bioequivalence studies seems to be a beneficial alternative to the 2 × 2 crossover study. Basic information on the properties of the active substance and the characteristics of the drug form are needed to make an initial decision to carry out the two-stage study.

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