Informatics and Computational Safety Analysis Staff (ICSAS)

About ICSAS

The Informatics and Computational Safety Analysis Staff (ICSAS) is part of CDER's Office of Pharmaceutical Science. ICSAS is an applied regulatory research unit that:

• Develops databases of toxicological and clinical endpoints
• Transforms data, developing rules for quantifying toxicological and clinical effects
• Evaluates structure activity relationship (SAR) and data mining software using ICSAS databases
• Works with software developers to develop toxicology and clinical effects prediction programs through research leveraging partnerships
• Reduces the use of animals in testing by eliminating non-critical laboratory studies
• Facilitates the review process by making better use of accumulated scientific knowledge
• Supplies tools to the pharmaceutical industry to develop better means to identify and eliminate compounds with potentially significant adverse properties early in the drug discovery and development process

Organization and Responsibilities

Programs and Activities

• Database Projects
  • Maximum Recommended Therapeutic Dose (MRTD) Database
  • Human Liver Adverse Effects Database
  • Genetic Toxicity, Reproductive and Developmental Toxicity, and Carcinogenicity Database (2/6/2006)
  • Salmonella Mutagenicity E-state Descriptors (2/6/2006)
• Chemical Structure Similarity Searching
• The Computational Toxicology Program and ComTox Consulting Service
• ComTox Regulatory Application of ICSAS MCASE/MC4PC-ES by the Center for Food Safety and Applied Nutrition
• Application of Computational Toxicology to Assess Clinical Adverse Drug Reactions
• Publications

Contact Us

Please send questions or comments concerning the contents of this page to Dan Benz at R.Daniel.Benz@fda.hhs.gov

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