• 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)

Data Management

Formatting of raw data should be well-documented and reproducible

1. Raw data formatting

- The original data files should be saved separately

- Scripts should be developed for raw data formatting to ensure transparent documentation. Manual formatting cannot be documented and may not be reproducible.

2. Maintenance of data directory

An example of how a data directory for a project could be maintained is given below:

o Each project could be saved as a separate folder in the personal directory.

o Under each project, there can be two folders, one for data and one for model.

-----DATA

-----MODEL

o The DATA folder may contain two folders, one for raw data and one for derived data.

-----RAW

-----DERIVED

o The MODEL folder may contain sub folders for PK and/or PD details.

-----PK

-----PD

o The PK and/or PD folder could contain the models attempted, which may be stored as subfolders.

-----STRUCTURAL MODEL

-----ONE COMPARTMENT

-----First order absorption

-----Zero order absorption

-----TWO COMPARTMENT

-----COVARIATE MODEL

-----CL VS AGE

-----CL vs CLcr and so on.......

3. An example of data directory.