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WinNonMix® — User-Friendly Population PK/PD Modeling
Pharsight® WinNonMix is designed to meet the need for population PK/PD analysis, particularly important in later phases of clinical trials. Population PK/PD analysis provides information on pharmacokinetics even from sparse data. It can provide a better understanding of how the drug should be used in the target population and explain possible differences in efficacy, in addition to providing a basis for simulation of your drug’s behavior in clinical trials and subpopulations.
Pharsight offers software evaluation licenses to commercial organizations |
Further, there is general regulatory agreement on the need to understand a drug's behavior in subgroups defined by specific factors (e.g., sex, ethnic group, age, renal function, weight, etc.). Population PK/PD analysis is an important tool in carrying out this subgroup analysis and provides a basis for understanding any differences that may exist.
WinNonMix is a sophisticated program for nonlinear mixed-effects modeling, to estimate the parameters in a nonlinear PK/PD model, approximate the distribution of those parameters in a population and estimate fixed and random effects in the model from observed data. WinNonMix provides these features in an interactive and easy-to-use Windows® application, with a user interface similar to that of WinNonlin®. Select PK/PD models from a predefined library or create user-defined compiled models. The library of predefined models includes all of the PK, PD, and PK/PD models used by WinNonlin. WinNonMix can estimate population parameter means as well as the between-individual variability in those parameters. WinNonMix is particularly useful with sparse data, when only a few measurements are available for each individual within a population.
WinNonMix models can include both fixed and random effects. Use it to estimate the influence of fixed effects, such as demographic and environmental factors, on the model parameters, and to estimate the magnitude of random influences.
WinNonMix provides a complete solution, with analysis, statistics, modeling, and visualization tools included in one package.
Enterprise data sharing and storage
WinNonMix’s Enterprise edition links WinNonMix’s modeling and analysis features to your clinical data infrastructure. WinNonMix Enterprise can exchange data with any ODBC-compliant database (e.g., Oracle, SAS, etc.), and includes a software developer’s kit to build custom query tools -- for example, a custom interface for a commercial LIMS product. For example, WinNonMix Enterprise can read rows of PK data from an ODBC-compliant database, and save analysis output back to a table in that database.
Benefits
- Sophisticated population modeling and analyses through a user-friendly interface
- Better understanding of how the drug should be used in the target population
- Understanding differences drug behavior across subpopulations
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