Bridging Studies versus Multiregional Trials

2016 ◽  
pp. 53-60
Keyword(s):  
Bridging Studies

Effective optimization of SARS-CoV-2 laboratory testing variables in an era of supply chain constraints

2020 ◽  
Vol 15 (15) ◽  
pp. 1483-1487
Author(s):  
Nikhil S Sahajpal ◽  
Ashis K Mondal ◽  
Allan Njau ◽  
Sudha Ananth ◽  
Kimya Jones ◽  
...  
Keyword(s):  
Supply Chain ◽  
Rna Extraction ◽  
Nasopharyngeal Swab ◽  
Sample Collection ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Short Supply ◽  
Viral Transport ◽  
3D Printed ◽  
Bridging Studies

RT-PCR-based assays for the detection of SARS-CoV-2 have played an essential role in the current COVID-19 pandemic. However, the sample collection and test reagents are in short supply, primarily due to supply chain issues. Thus, to eliminate testing constraints, we have optimized three key process variables: RNA extraction and RT-PCR reactions, different sample types and media to facilitate SARS-CoV-2 testing. By performing various validation and bridging studies, we have shown that various sample types such as nasopharyngeal swab, bronchioalveolar lavage and saliva, collected using conventional nasopharyngeal swabs, ESwab or 3D-printed swabs and, preserved in viral transport media, universal transport media, 0.9% sodium chloride or Amies media are compatible with RT-PCR assay for COVID-19. Besides, the reduction of PCR reagents by up to fourfold also produces reliable results.

Bridging Studies

2012 ◽  
pp. 208-211
Author(s):  
Jen-pei Liu
Keyword(s):  
Bridging Studies

Two-Stage Designs of Bridging Studies

2012 ◽  
pp. 17-32
Author(s):  
Chin-Fu Hsiao ◽  
Hsiao-Hui Tsou ◽  
Jen-pei Liu ◽  
Yuh-Jenn Wu
Keyword(s):  
Two Stage ◽  
Bridging Studies

PK/PD Bridging Studies

2021 ◽  
pp. 159-172
Author(s):  
Fuyu Song ◽  
Xin Zheng ◽  
Shein-Chung Chow
Keyword(s):  
Bridging Studies

Statistical Methods for Bridging Studies

2012 ◽  
Vol 22 (5) ◽  
pp. 903-915 ◽  
Author(s):  
Shein-Chung Chow ◽  
Chieh Chiang ◽  
Jen-pei Liu ◽  
Chin-Fu Hsiao
Keyword(s):  
Statistical Methods ◽  
Bridging Studies

BAYESIAN APPROACH TO EVALUATION OF BRIDGING STUDIES

2002 ◽  
Vol 12 (3) ◽  
pp. 401-408 ◽  
Author(s):  
Jen-pei Liu ◽  
Chin-Fu Hsiao ◽  
Hueymiin Hsueh
Keyword(s):  
Bayesian Approach ◽  
Bridging Studies
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