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Fully Validated and Part 11 Compliant Pharmacometric Suite with a Version Controlled Data Repository

Performing Pharmacokinetic (PK) and/or Pharmacodynamic (PD) analyses compliant with the regulatory expectations of many global health authorities presents several operational and technical challenges. Regulatory requirements mandate that all PK/PD analyses that support drug approval packages are conducted within a validated environment and with proper documentation to support the methodology used to validate said environment. With multiple software programs, data transfer mechanisms, and servers utilized across the majority of PK/PD analyses, the validation of an analysis environment requires assiduous planning and testing to meet regulatory expectations. As such, groups that carry the remit of validation often utilize systems that are inefficient and rate limiting in the drug development process. Herein is presented a streamlined approach to construct a fully validated clinical pharmacology (CP) computing platform (CPCP) to address the shortcomings of many validated environments.

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