• 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

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Model validation/qualification

A model and its set of parameters are deemed "qualified" to perform particular task(s) if they satisy a pre-specified criteria.¹

Currently, there is no consensus on an appropriate statistical approach to qualify population PK models. Recently, there was a conference on model qualification, where various approaches and case studies were discussed. ²

FDA guidance provides different types of model validation and validation methods.

References

1. Gobburu,J & Marroum,P:Utilisation of pharmacokinetic-pharmacodynamic modeling and simulation in regulatory decision making.
2. ECPAG 2004