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Population PK/PD approach

The modeling of pharmacokinetics and pharmacodynamics (PK/PD) was historically the first mathematical approach used for drug research and development. Currently, this field has a great number of methods and techniques for analysis of preclinical and clinical data, as well as for clinical design optimization, due to the development of specific mathematical methods and software packages. One of the important and powerful approaches for PK/PD modeling is the “population approach,” which works in terms of Bayesian statistical values for more adequate modeling of both individual and population parameters.

Method application:

  • Analysis of clinical PK/PD trials results, including data with high measured variability;
  • Development of the optimal clinical design and strategy for cost reducing or to increase patient safety;
  • Analysis of preclinical PK/PD data with high variability in experimental points;
  • Strengthening classical biostatistics approaches for more accurate and reasonable conclusions regarding success or failure of clinical trials results;
  • Optimization of dose and treatment regimens for the safest and most effective treatment;
  • Analysis and explanation of variability in results for special populations, including renal and liver failure, etc. Dose correction;
  • Search and analysis of correlations between PK/PD parameters and human characteristics: gender, weight, height, etc.