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Review

Assay Guidance Manual [Internet]

Sarine Markossian  1 , Abigail Grossman  1 , Hannah Baskir  1 , Michelle Arkin  2 , Douglas Auld  3 , Christopher Austin  4 , Jonathan Baell  5 , Kyle Brimacombe  1 , Thomas D.Y. Chung  6 , Nathan P. Coussens  7 , Jayme L. Dahlin  8 , Viswanath Devanarayan  9 , Timothy L. Foley  10 , Marcie Glicksman  11 , Kirill Gorshkov  12 , Stefan Grotegut  13 , Matthew D. Hall  1 , Samuel Hoare  14 , James Inglese  1 , Philip W. Iversen  15 , Madhu Lal-Nag  16 , Zhuyin Li  12 , Jason R. Manro  13 , James McGee  17 , Allison Norvil  13 , Mackenzie Pearson  13 , Terry Riss  18 , Peter Saradjian  19 , G. Sitta Sittampalam  20 , Michael A. Tarselli  21 , O. Joseph Trask Jr.  22 , Jeffrey R. Weidner  23 , Mary Jo Wildey  24 , Kelli Wilson  1 , Menghang Xia  1 , Xin Xu  1
, editors.
Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004.
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Free Books & Documents
Review

Assay Guidance Manual [Internet]

Editors:Sarine Markossian et al.
Free Books & Documents

Excerpt

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:

  1. Descriptions of assay formats that are compatible with HTS and determination of SAR

  2. Selection and development of optimal assay reagents

  3. Optimizations and troubleshooting for assay protocols with respect to sensitivity, dynamic range, signal intensity and stability

  4. Adaptations of assays for automation and scaling to microtiter plate formats

  5. Instrumentation

  6. Sources of assay artifacts and interferences

  7. Statistical validation of assay performance parameters

  8. Secondary assays for chemical probe validation and SAR refinement

  9. Data standards for reporting the results of screening and SAR assays

  10. In vivo assay development and validation

  11. 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.

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