AI Article Synopsis
- There is increasing concern in the scientific community about the need for a standardized process to ensure the stability of biomarker specimens used in drug development.
- The text emphasizes sharing best practices for preserving the integrity of these specimens during clinical trials and highlights the importance of designing studies that assess stability.
- The overview includes key aspects such as planning sample collection, training clinical sites, selecting preservation methods, logistics for shipping, and stability assessments in labs, along with relevant case studies.
Article Abstract
With the wide use of biomarkers to enable critical drug-development decisions, there is a growing concern from scientific community on the need for a 'standardized process' for ensuring biomarker specimen stability and hence, a strong desire to share best practices on preserving the integrity of biomarker specimens in clinical trials and the design of studies to evaluate analyte stability. By leveraging representative industry experience, we have attempted to provide an overview of critical aspects of biomarker specimen stability commonly encountered during clinical development, including: planning of clinical sample collection procedures, clinical site training, selection of sample preservation buffers, shipping logistics, fit-for-purpose stability assessments in the analytical laboratory and presentation of case studies covering widely utilized biomarker specimen types.
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| http://dx.doi.org/10.4155/bio-2017-0009 | DOI Listing |
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