Assay Guidance Manual

Assay Guidance Manual cover

The Assay Guidance Manual (AGM) is a free, best-practices online resource devoted to the successful development of robust, early-stage drug discovery assays.

The manual was originally developed by Eli Lilly and Company to provide step-by-step guidance based on “tribal knowledge” from drug developers for planning and creating projects for high-throughput screening, lead optimization and early phases of regulated drug development. Tribal knowledge is any unwritten, well-tested information that is not commonly known by others within an institution. Well-tested methods outlined in the manual address appropriate statistical ways to analyze assay results and accommodate minor changes to assay protocols to ensure robustness.

Investigators worldwide can use the manual to design biologically and pharmacologically relevant assays for high-throughput screening and lead optimization to evaluate collections of molecules that modulate the activity of biological targets, pathways and cellular phenotypes.

NCATS manages the content of the manual with input from industry, academia and government experts. More than 100 authors from around the world have contributed content to this free resource, which is updated quarterly and housed by the National Library of Medicine. The chapters have PubMed citations for the contributing authors.

View the latest Assay Guidance Manual fact sheet (PDF - 229KB) to learn more about this NCATS-led initiative.

Training Opportunities

NCATS offers AGM training workshops designed to share best practices and advice on robust assay design, development, and implementation for researchers involved in the drug discovery process. Learn more about these training opportunities.

AGM Publications

Read publications about the AGM initiative.


Sarine Markossian, Ph.D.