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Cover of Assay Guidance Manual

Assay Guidance Manual

Editors: G. Sitta Sittampalam, PhD, Editor-in-chief, Nathan P. Coussens, PhD, Editor-in-chief, Kyle Brimacombe, MS, Associate Scientific Editor, Abigail Grossman, Associate Managing Editor, Michelle Arkin, PhD, Douglas Auld, PhD, Chris Austin, MD, Jonathan Baell, PhD, Bruce Bejcek, PhD, Thomas D.Y. Chung, PhD, Jayme L. Dahlin, MD, PhD, Viswanath Devanaryan, PhD, Timothy L. Foley, PhD, Marcie Glicksman, PhD, Matthew D. Hall, PhD, Joseph V. Hass, MS, James Inglese, PhD, Philip W. Iversen, PhD, Madhu Lal-Nag, PhD, Zhuyin Li, PhD, James McGee, PhD, Owen McManus, PhD, Terry Riss, PhD, O. Joseph Trask, Jr., Jeffrey R. Weidner, PhD, Menghang Xia, PhD, and Xin Xu, PhD.

Editor Information

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,, the newest component of the National Institutes of Health (NIH).


Previous Editors: Lisa Minor, PhD, Vance Lemmon, PhD, Andrew Napper, PhD, John M Peltier, PhD, Henrike Nelsen, MS, and Neely Gal-Edd, MS

Contact Information: vog.hin.liam@srotidE_MGA_STACN

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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