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Using DTA and DTAARRAY variables and programming in WinNonlin ASCII models to streamline user-defined calculation and

Jun Shen1, Shuanglian Li, Ronald R Bowsher

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This study introduces an automated method for user-defined calculations in pharmacokinetic (PK) analysis using WinNonlin software. The approach leverages DTA variables and programming to reduce data defects and manual handling in PK modeling.

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Area of Science:

  • Pharmacokinetics
  • Computational Chemistry
  • Data Science

Background:

  • User-defined calculations in pharmacokinetic (PK) analysis are often performed manually outside primary modeling.
  • Manual data processing increases the risk of data defects and non-compliance with software standards.
  • Existing methods require extensive pre- or post-processing of data from multiple sources.

Purpose of the Study:

  • To propose and demonstrate an automated method for user-defined calculations within WinNonlin PK analysis.
  • To eliminate manual data handling and reduce potential data defects.
  • To enhance the efficiency and compliance of PK analysis workflows.

Main Methods:

  • Leveraging Data Text Array (DTA) and DTAARRAY variables within ASCII models in WinNonlin.
  • Implementing simple programming techniques to automate calculations.
  • Demonstrating the method through three case studies: post-processing, pre-processing with baseline correction, and in vitro bioequivalence calculations.

Main Results:

  • Successfully automated user-defined parameter calculations within the primary PK model (Case 1).
  • Developed a baseline correction decision tree for PK models, accounting for endogenous levels and residual drug (Case 2).
  • Utilized DTAARRAY variables for looping operations to calculate difference (F1) and similarity (F2) factors for bioequivalence (Case 3).

Conclusions:

  • The proposed method effectively automates user-defined calculations in PK analysis using WinNonlin.
  • This automation reduces manual intervention, minimizes data defects, and improves compliance.
  • The strategy is versatile, applicable to post-processing, pre-processing, and in vitro bioequivalence evaluations.