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

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  • Theme: Ligand Binding Assays in the 21st Century Laboratory
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Fig. 1
Fig. 2

Abbreviations

API:

Application programming interface

ERES:

Electronic Records and Electronic Signatures regulations (US FDA 21 CFR Part 11)

GLP:

Good Laboratory Practice regulations (21 CFR Part 58)

GUID:

Globally unique identifier

IT:

Information technology

LBA:

Ligand-binding assay

LC/MS:

Liquid chromatography/mass spectrometry

LIMS:

Laboratory information management system

SDK:

Software development kit

USB:

Universal serial bus

REFERENCES

  1. www.21cfrpart11.com/pages/faq/index.htm

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  4. Universal Serial Bus Implementers Forum, Inc.:Universal Serial Bus 3.0 Specification (2011). Hewlett-Packard, Intel, Microsoft, NEC, ST_Ericsson, Texas Instruments. Accessed 16 Dec 2011

  5. Universal Serial Bus Implementers Forum, Inc.: http://www.usb.org/about. Accessed 16 Dec 2011

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ACKNOWLEDGMENTS

The authors would like to acknowledge Jim King’s efforts in initiating this effort, Chad Briscoe’s participation on this subcommittee, and Ago Ahene, Marian Kelley, Denise O’Hara, Jean Lee, and Philip Oldfield for their review and comments. This manuscript was prepared by members of the 21st Century Bioanalytical Laboratory: eSolutions Subcommittee of the Ligand Binding Assay Bioanalytical Focus Group (LBABFG).

Conflict of interest

This article describes two commercial systems: MasterPlex® from Hitachi Solutions America and Integration Manager from Thermo Scientific. Robert Lynde and Joel Usansky are employees of Hitachi Solutions America and Thermo Scientific, respectively. These two systems were provided as examples of commercially available systems that do not provide a complete solution. To the authors’ best knowledge, due to the lack of a universally accepted automated data interchange process, there are currently no commercially available systems that provide the complete solution that we seek.

Author information

Authors and Affiliations

  1. Pfizer Inc., 1 Burtt Rd, Andover, Massachusetts, 01810, USA

    Sheldon S. Leung

  2. Thermo Fisher Scientific, Philadelphia, Pennsylvania, 19102, USA

    Joel Usansky

  3. Hitachi Solutions America, Ltd., South San Francisco, California, 94080, USA

    Robert Lynde

  4. Amgen Inc., Thousand Oaks, California, 93012, USA

    Theingi Thway

  5. Genentech Inc., South San Francisco, California, 94080, USA

    Robert Hendricks

  6. BioAgilytix Labs, Inc., Durham, North Carolina, 27713, USA

    David Rusnak

Authors
  1. Sheldon S. Leung
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  2. Joel Usansky
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  3. Robert Lynde
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  4. Theingi Thway
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  5. Robert Hendricks
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  6. David Rusnak
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Corresponding author

Correspondence to Sheldon S. Leung.

Additional information

Guest Editors: William Nowatzke, Ago Ahene and Chad Ray

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Leung, S.S., Usansky, J., Lynde, R. et al. Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process. AAPS J 14, 105–112 (2012). https://doi.org/10.1208/s12248-011-9319-0

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  • DOI: https://doi.org/10.1208/s12248-011-9319-0

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