• Terms and Definitions 1
  • Variable
  • Parameter
  • Model
  • Linear and Nonlinear model
  • Fixed effect parameter
  • Random effect parameter
  • Mixed effects modeling
  • Structural model
  • Random effect model
  • Population PK and PD
• Terms and Definitions 2
  • Maximum likelihood
  • Objective function value
  • Log-likelihood ratio
  • Optimization procedure
  • Point estimate
  • Confidence intervals
  • Maximum a posteriori/post hoc estimates
  • Simulation
  • Clinical trial design
  • Pharmacodynamic terms
• Population analysis methods
  • Naive pooled data approach (NPD)
  • Naive averaged data approach (NAD)
  • Standard two-stage approach (S2S)
  • Three stage analysis (3S)
  • Bayesian estimation
  • One stage analysis
• Estimation methods
  • Ordinary least squares (OLS)
  • Weighted least squares (WLS)
  • Extended least squares (ELS)
• Good Modeling Practices (GMP)
  • Data management
  • Rational modeling process
  • Report

Good Modeling Practices (GMP)

Rational model building

Project plan
Preliminary data analysis
Determination of initial model
Covariate model building
Evaluation of final parameter estimates and model selection
Model validation/qualification

Next

Project plan

All models are exploratory

The first step in the modeling process would be to develop a project plan.

It is important to identify the critical questions that are intended to be answered. For primary analysis in pivotal clinical trials, the modeling plan has to be mentioned a priori.