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Cover of Assay Guidance Manual

Assay Guidance Manual

Edited by G. Sitta Sittampalam, PhD, Editor-in-chief, Neely Gal-Edd, MS, Associate Managing Editor, Michelle Arkin, PhD, Douglas Auld, PhD, Chris Austin, MD, Bruce Bejcek, PhD, Marcie Glicksman, PhD, James Inglese, PhD, Vance Lemmon, PhD, Zhuyin Li, PhD, James McGee, PhD, Owen McManus, PhD, Lisa Minor, PhD, Andrew Napper, PhD, Terry Riss, PhD, O. Joseph Trask, Jr., and Jeff Weidner, PhD.

Editor Information

Edited by G. Sitta Sittampalam, PhD, Editor-in-chief,1 Neely Gal-Edd, MS, Associate Managing Editor,2 Michelle Arkin, PhD,3 Douglas Auld, PhD,4 Chris Austin, MD,5 Bruce Bejcek, PhD,6 Marcie Glicksman, PhD,7 James Inglese, PhD,8 Vance Lemmon, PhD,9 Zhuyin Li, PhD,10 James McGee, PhD,11 Owen McManus, PhD,12 Lisa Minor, PhD,13 Andrew Napper, PhD,14 Terry Riss, PhD,15 O. Joseph Trask, Jr.,16 and Jeff Weidner, PhD17.

1 National Center for Advancing Translational Sciences, National Institutes of Health
2 National Center for Advancing Translational Sciences, National Institutes of Health
3 University of California, San Francisco
4 Novartis Institutes for Biomedical Research
5 National Center for Advancing Translational Sciences, National Institutes of Health
6 Western Michigan University
7 Harvard NeuroDiscovery Center
8 National Center for Advancing Translational Sciences, National Institutes of Health
9 University of Miami
10 National Center for Advancing Translational Sciences, National Institutes of Health
11 Eli Lilly & Company
12 Johns Hopkins Ion Channel Center, Johns Hopkins School of Medicine
13 In Vitro Strategies, LLC
14 Nemours Center for Childhood Cancer Research, Jefferson Medical College, Wilmington DE
15 Promega Corporation
16 The Hamner Institutes for Health Sciences
17 Eli Lilly & Company

The collection of chapters in this eBook is written to provide guidance to investigators who are interested in developing assays useful for the evaluation of collections of molecules to identify probes that modulate the activity of biological targets, pathways, and cellular phenotypes. These probes may be candidates for further optimization and investigation in drug discovery and development.

Originally written as a guide for therapeutic project teams within a major pharmaceutical company, this manual has been adapted to provide guidelines for scientists in academic, non-profit, government and industrial research laboratories to develop potential assay formats compatible with High Throughput Screening (HTS) and Structure Activity Relationship (SAR) measurements of new and known molecular entities. Topics addressed in this manual include:

  • Development of optimal assay reagents.
  • Optimization of assay protocols with respect to sensitivity, dynamic range, signal intensity and stability.
  • Adopting screening assays from bench scale assays to automation and scale up in microtiter plate formats.
  • Statistical concepts and tools for validation of assay performance parameters.
  • Secondary follow up assay development for chemical probe validation and SAR refinement.
  • Data standards to be followed in reporting screening and SAR assay results.
  • Glossaries and definitions.

This manual will be continuously updated with contributions from experienced scientists from multiple disciplines working in drug discovery & development worldwide. An open submission and review process will be implemented in the near future on this eBook website, hosted by the National Library of Medicine with content management by the National Center for Advancing Translational Sciences (NCATS, http://ncats.nih.gov/), the newest component of the National Institutes of Health (NIH).

Contents

Cover photo courtesy of Manju Swaroop, Research Scientist, NCATS

Copyright Notice

All Assay Guidance Manual content, except where otherwise noted, is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported license (CC BY-NC-SA 3.0), which permits copying, distribution, transmission, and adaptation of the work, provided the original work is properly cited and not used for commercial purposes. Any altered, transformed, or adapted form of the work may only be distributed under the same or similar license to this one.

Bookshelf ID: NBK53196PMID: 22553861
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