FDA-iRISK^® 4.2

Home Risk Models Reports Repositories Help

What's New in FDA-iRISK 4.2

Process Models

Concentration threshold exceedance process type for acute and chronic scenarios

Risk Scenarios

Lifetime Average Daily Dose (LADD) Exceedance feature for chronic, single food scenarios
Sensitivity analysis now available in most scenario types, including multi-food and exposure only
Enhanced error messaging on sensitivity analysis tab

Predictive Microbiology Models

Baranyi-Roberts primary growth model which accepts parameters from DMFit at ComBase.cc

Dose Response Models

APROBA dose response model now available for chronic chemical scenarios

Reports

Empirical and Chance parameter definitions moved to an appendix for a more compact scenario summary in Risk Estimates and Scenario Ranking reports

New Distribution Options

Laplace distribution
Lognormal distribution defined with median

Features Added Previously in FDA-iRISK 4.1

Process Models

Import multiple parameter set initial conditions for microbial process models
Input linked uncertainty distributions for initial conditions for microbial process models

Risk Scenarios

Run a risk ranking report directly from the edit risk scenario page
Streamlined sensitivity analysis parameterization for supported scenario types
View all scenario model elements on the sensitivity analysis tab for supported scenario types
Direct link to model element edit page on the sensitivity analysis tab for supported scenario types

Predictive Microbiology Models

Import empirical growth and inactivation curves/models
New secondary growth model
New secondary lag model
Most secondary models now support distributions and uncertainty for model parameters

Dose Response Models

Import Empirical dose response models from text or Excel files

Reports

Export chronic chemical exposure results to Excel

Features Added Previously 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