• 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)

Report

A population analysis report usually contains the following sections as recommended in the FDA guidance.

1. Executive summary

   This is the first section any population analysis report should contain. The summary should be written in an easily understandable language, with no technical terms used. It should provide the gist of the whole analysis in a clear concise manner, easily comprehensible to non-pharmacometricians too.

2. Introduction
3. Objective, hypotheses and assumptions
4. Assay
5. Data
6. Data analysis methods
7. Results
8. Discussion
9. Application of results
10. Appendix
11. Electronic format file