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Home -> Help -> What's New in FDA-iRISK 4.0

What's New in FDA-iRISK 4.0

2D Monte Carlo Simulation

  • Explicitly include probabilistic uncertainty and variability as separate dimensions (2D Monte Carlo Simulation)
  • Define uncertainty for most model parameters
  • Specify the settings used for variability and uncertainty simulations, including convergence criteria

Risk Scenarios

  • Create a multi-food scenario to capture chronic exposure of the consumer to a hazard found in multiple foods
  • Perform risk-risk and risk-benefit analysis with multi-hazard, multi-food chronic scenarios
  • Compare risks from chronic hazards among consumers with different dietary patterns
  • Improved parameter validation
  • QALY health metric now available

Sensitivity Analysis

  • New multi-parameter sensitivity analysis design
  • Specify parameters for multiple parameters simultaneously
  • Sensitivity analysis settings now saved with scenario

Process Models

  • Incorporate predictive models for microbial growth and inactivation
  • Parallel process models for microbial hazards
  • Linked process model to different downstream process models
  • Microbial toxin process models (using linked models)
  • Sampling process type
  • Cross contamination (addition) by transfer rate process type
  • Non-log distributions for microbial concentrations and counts
  • Define unit size as a distribution

Dose Response Models

  • Create custom dose response models with the empirical dose response model
  • Chronic monotonically decreasing dose response to evaluate health benefits
  • Define uncertainty on parameters separately or as linked sets
  • Import dose response models from shared library

Consumption Models

  • Multi-food consumption models
  • Populations groups renamed to lifestages for chronic consumption models
  • Import consumption models from shared library

Reports

  • Combine scenarios from different repositories in the same report
  • Option to rank by exposure
  • Simulation job notifications
  • Convergence report
  • Edit title and abstract for completed reports

UI Experience

  • Centralized notes for model elements
  • Link back to scenarios from the reports page for quick review
  • Improved charts

Distributions

  • Import empirical distributions
  • Specify Uniform and Triangular distributions using 5th and 95th percentiles

Features Added Previously in FDA-iRISK 2.0

Process Models

  • Maximum Population Density (MPD) now included for microbial models
  • "Increase by Addition" now handles rare event additions
  • Variability distributions now include: Beta, Beta General, Normal (Truncated), and Triangular (Truncated)

Dose Response Models

  • Microbial hazards now include: Threshold Linear and Weibull
  • Acute chemical hazards now include: Cumulative Lognormal and Weibull
  • Chronic chemical hazards now include: Log-Logistic with Background, Probit, Restricted Weibull, and Restricted Log Probit

Consumption Models

  • Chronic consumption can now be defined in "g/kg-day"
  • Variability distributions now include: Beta, Beta General, Lognormal, Normal (Truncated), and Triangular (Truncated)

Sensitivity Analysis

  • Access a new tab for sensitivity analysis directly from Edit Risk Scenario page, to answer "what-if" questions
  • Perform sensitivity analysis on acute and chronic risk scenario
  • Analyze any model component
  • Print a report on sensitivity analysis results

Model Management

  • Create multiple repositories to manage your models
  • Share model repositories separately
  • Import and copy individual model elements

Reports

  • Enhanced report layout
  • Options for Word and Excel reports
  • Include weighted scenarios when generating risk estimates and scenario ranking reports
  • Report results for risk scenarios for chronic exposure as annualized or full lifespan
  • Multiple options for ranking risk estimates

Risk Scenarios

  • Create risk scenarios for exposure only models

UI Experience

  • Plotted dose response models and distribution charts for graphic representations of dose response relationships and variability in contamination and consumption