FDA RFQ: ICON NONMEM License and Maintenance Renewal (Brand Name or Equal)

Notice ID: FDA-RFQ-22-1254213

“Objective: The objective of this requirement is to renew NONMEM/PDx-PoP software license subscription or acquire an equivalent software that can meet the Government’s needs.”

“Requirements: Software License, NONMEM

The salient characteristics for the NONMEM Software License, brand name or equal, are listed below. The Contractor shall provide a brand name or an equal-to product that meets the following software license salient characteristics.

• The following population analysis methods must be available:
  1. First Order Conditional Estimation (FOCE)
  2. Laplace Conditional Estimation
  3. Iterative Two Stage (ITS)
  4. Importance Sampling Expectation-Maximization (IMP)
  5. Stochastic Approximation Expectation-Maximization (SAEM)
  6. Markov-Chain Monte Carlo Bayesian Analysis (BAYES)
• Parallel computing of a single problem over multiple cores or computers
• Dynamic memory allocation according to problem size.
• Capable of using the first-order conditional estimation method.
• Multiple mixed effects levels, with random effects across groups of individuals such as clinical site
• Symbolic reference to thetas, etas, and epsilons.
• Variance matrix parameters output in covariance and correlation format.
• Variance matrix parameters in covariance, correlation, or Cholesky format.
• Enhanced annealing feature for SAEM to facilitate estimation of fixed effect parameters (THETAs) that do not have associated inter-subject variance (ETA’s).
• Boot-strap simulations…”

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