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Software and Validation

PhinC development has mastered five software tools, covering all the pharmacometric and statistical aspects of drug development. Those reference tools fit in with both the best operational practices and regulatory expectations.

Software

WinNonLin assesses pharmacokinetics by performing non-compartmental and compartmental analysis.

NONMEM and Monolix are two reference software tools for population pharmacokinetics analysis (PK, PD, PK/PD).

SAS package is the main software tool for producing statistics in relation to clinical development. Handled by our skilled biostatisticians, it can shed light on and interpret huge databases and can generate appropriate data reporting.

GastroPlus software is used for all Physiology Based PharmacoKinetic (PBPK) studies. In particular, it helps to provide all the necessary steps when moving from preclinical to clinical studies.

Other calculation and computerized software tools are also used for support or exploratory purposes.

Computerized Validation System

All of those software tools are monitored by a strict computerized validation system, provided by 21 CFR (Code of Federal Regulation) Part 11. PhinC is committed to strictly following the GAMP (Good Automated Manufacturing Practice) guidelines on behalf of its clients and partners. We follow all of the industry’s best practices and are compliant with all current regulatory expectations. A maintenance protocol is established to ensure you receive perfect quality in our services throughout the process.