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Clin Transl Sci. 2018 Sep;11(5):461-470. doi: 10.1111/cts.12570. Epub 2018 Jul 24.

Assay Guidance Manual: Quantitative Biology and Pharmacology in Preclinical Drug Discovery.

Author information

1
National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, United States.
2
Conrad Prebys Center for Chemical Genomics, Sanford Burnham Prebys Medical Discovery Institute, La Jolla, California, United States.
3
QualSci Consulting, LLC, Carmel, Indiana, United States.
4
Promega Corporation, Madison, Wisconsin, United States.
5
PerkinElmer, Inc., Waltham, Massachusetts, United States.
6
Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, United States.
7
Brigham and Women's Hospital, Boston, Massachusetts, United States.
8
Charles River Laboratories, Souderton, Pennsylvania, United States.
9
Pfizer Worldwide Research and Development, Groton, Connecticut, United States.
10
Eli Lilly and Company, Indianapolis, Indiana, United States.
11
Small Molecule Discovery Center, Department of Pharmaceutical Chemistry, University of California, San Francisco, California, United States.
12
Medicinal Chemistry, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Australia.
13
Department of Biological Sciences, Western Michigan University, Kalamazoo, Michigan, United States.
14
MacroGenics, Inc., Rockville, Maryland, United States.
15
Orig3n, Boston, Massachusetts, United States.
16
National Library of Medicine, National Center for Biotechnology Information, Bethesda, Maryland, United States.
17
Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, Florida, United States.
18
Bristol-Myers Squibb, Lead Discovery and Optimization, Princeton, New Jersey, United States.
19
Q-State Biosciences, Cambridge, Massachusetts, United States.
20
In Vitro Strategies, LLC, Flemington, New Jersey, United States.
21
FLX Bio, Inc., San Francisco, California, United States.
22
Merck Research Laboratories, Kenilworth, New Jersey, United States.
23
CHDI Management, Inc./CHDI Foundation, Inc., Los Angeles, California, United States.
24
Harvard Medical School, Boston, Massachusetts, United States.

Abstract

The Assay Guidance Manual (AGM) is an eBook of best practices for the design, development, and implementation of robust assays for early drug discovery. Initiated by pharmaceutical company scientists, the manual provides guidance for designing a "testing funnel" of assays to identify genuine hits using high-throughput screening (HTS) and advancing them through preclinical development. Combined with a workshop/tutorial component, the overall goal of the AGM is to provide a valuable resource for training translational scientists.

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