scholarly journals Leveraging Digital Health Technologies and Outpatient Sampling in Clinical Drug Development: A Phase I Exploratory Study

2018 ◽  
Vol 105 (1) ◽  
pp. 168-176 ◽  
Author(s):  
Marissa F. Dockendorf ◽  
Gowri Murthy ◽  
Kevin P. Bateman ◽  
Prajakti A. Kothare ◽  
Melanie Anderson ◽  
...  
Keyword(s):  
Drug Development ◽  
Phase I ◽  
Exploratory Study ◽  
Digital Health ◽  
Health Technologies ◽  
Clinical Drug Development ◽  
Clinical Drug

Harnessing the Potential of Emerging Digital Health and Biological Sampling Technologies for Clinical Drug Development: Promise to Reality

2018 ◽  
Vol 104 (6) ◽  
pp. 1125-1135 ◽  
Author(s):  
Prajakti A. Kothare ◽  
Pravin R. Jadhav ◽  
Pankaj Gupta ◽  
Jane Croft Harrelson ◽  
Leslie Dickmann
Keyword(s):  
Drug Development ◽  
Digital Health ◽  
Clinical Drug Development ◽  
Biological Sampling ◽  
Clinical Drug

scholarly journals Has molecular imaging delivered to drug development?

2017 ◽  
Vol 375 (2107) ◽  
pp. 20170112 ◽  
Author(s):  
Philip S. Murphy ◽  
Neel Patel ◽  
Timothy J. McCarthy
Keyword(s):  
Molecular Imaging ◽  
Drug Development ◽  
Clinical Studies ◽  
Pharmaceutical Research ◽  
Whole Body ◽  
Drug Candidate ◽  
Clinical Drug Development ◽  
Target Binding ◽  
The Brain ◽  
Clinical Drug

Pharmaceutical research and development requires a systematic interrogation of a candidate molecule through clinical studies. To ensure resources are spent on only the most promising molecules, early clinical studies must understand fundamental attributes of the drug candidate, including exposure at the target site, target binding and pharmacological response in disease. Molecular imaging has the potential to quantitatively characterize these properties in small, efficient clinical studies. Specific benefits of molecular imaging in this setting (compared to blood and tissue sampling) include non-invasiveness and the ability to survey the whole body temporally. These methods have been adopted primarily for neuroscience drug development, catalysed by the inability to access the brain compartment by other means. If we believe molecular imaging is a technology platform able to underpin clinical drug development, why is it not adopted further to enable earlier decisions? This article considers current drug development needs, progress towards integration of molecular imaging into studies, current impediments and proposed models to broaden use and increase impact. This article is part of the themed issue ‘Challenges for chemistry in molecular imaging’.

Potential of metabolomics in preclinical and clinical drug development

2014 ◽  
Vol 66 (6) ◽  
pp. 956-963 ◽  
Author(s):  
Baldeep Kumar ◽  
Ajay Prakash ◽  
Rakesh Kumar Ruhela ◽  
Bikash Medhi
Keyword(s):  
Drug Development ◽  
Clinical Drug Development ◽  
Clinical Drug

scholarly journals Assessment of cognitive safety in clinical drug development

2016 ◽  
Vol 21 (3) ◽  
pp. 445-453 ◽  
Author(s):  
Jonathan P. Roiser ◽  
Pradeep J. Nathan ◽  
Adrian P. Mander ◽  
Gabriel Adusei ◽  
Kenton H. Zavitz ◽  
...  
Keyword(s):  
Drug Development ◽  
Clinical Drug Development ◽  
Clinical Drug
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