Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process

Journal Title: The AAPS Journal - Year 2012, Vol 14, Issue 1

Abstract

One useful concept that is aligned with the idea of an automated data interchange process is the Globally Unique ID (GUID), also known as a Universally Unique Identifier. These special purpose identifiers are 32-character hexadecimal strings which enable computerized systems to uniquely identify a single physical entity. In the context of LBAs, GUIDs could be used to describe samples, child samples, and sample-replicates as the physical samples and/or tubes progress through clinical study conduct from central laboratory, to doctor’s office, to bioanalytical laboratory, to clinical data management group, to biostatistics, and finally to submission to regulatory authorities. GUIDs do not require central coordination and could be used to identify samples uniquely. This has practical utility because the bioanalytical laboratory receives samples from multiple sample sources such as pharmaceutical companies, other departments in the same company, universities conducting clinical trials, CROs, and central laboratories, each of which may have their own computerized system with its own barcode numbering schemes. It can be visualized that systems may have to deal with multiple GUIDs: one generated by itself as well as other(s) imported during a prior sample transfer process. Thus, the ability to exchange multiple GUIDs from one system to another represents a potential breakthrough in developing a global, universal sample exchange mechanism.

Authors and Affiliations

Sheldon S. Leung, Joel Usansky, Robert Lynde, Theingi Thway, Robert Hendricks, David Rusnak

Keywords

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  • EP ID EP681197
  • DOI  10.1208/s12248-011-9319-0
  • Views 82
  • Downloads 0

How To Cite

Sheldon S. Leung, Joel Usansky, Robert Lynde, Theingi Thway, Robert Hendricks, David Rusnak (2012). Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process. The AAPS Journal, 14(1), -. https://europub.co.uk/articles/-A-681197