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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, Steven D. Kahl, BS, Stephen C. Kales, 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

This eBook is a comprehensive, crucial resource for investigators optimizing assays to evaluate collections of molecules with the overall goal of developing probes that modulate the activity of biological targets, pathways or cellular phenotypes. Such probes might 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 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:

  • Descriptions of assay formats that are compatible with HTS and determination of SAR
  • Selection and development of optimal assay reagents
  • Optimizations and troubleshooting for assay protocols with respect to sensitivity, dynamic range, signal intensity and stability
  • Adaptations of assays for automation and scaling to microtiter plate formats
  • Instrumentation
  • Sources of assay artifacts and interferences
  • Statistical validation of assay performance parameters
  • Secondary assays for chemical probe validation and SAR refinement
  • Data standards for reporting the results of screening and SAR assays
  • In vivo assay development and validation
  • Assay development and validation for siRNA-based high-throughput screens

The National Center for Advancing Translational Sciences (NCATS) manages the content of the Assay Guidance Manual with input from industry, academia and government experts. More than 100 authors from around the globe have contributed content to this free resource, which is updated quarterly with contributions by experienced scientists from multiple disciplines working in drug discovery and development worldwide.

For more information about the Assay Guidance Manual and related training opportunities, visit https://ncats.nih.gov/expertise/preclinical/agm.

Contents

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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