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NCA The Power of Simplicity

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Page 1: The Power of Simplicity - Pharmetheus Pharmetheus.pdf · The Power of Simplicity. Non-Compartmental Analysis The NCA produces standard PK parameters (e.g., Cmax and AUC) to support

NCAThe Power of Simplicity

Page 2: The Power of Simplicity - Pharmetheus Pharmetheus.pdf · The Power of Simplicity. Non-Compartmental Analysis The NCA produces standard PK parameters (e.g., Cmax and AUC) to support

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Non-Compartmental Analysis

The NCA produces standard PK parameters (e.g., Cmax and AUC) to support regulatory decisions, such as first-time-in-man studies, special populations, bio equivalence and drug-drug interactions.

The NCA may be customized for efficient early phase study design. Listings, tables and figures are always tailored to the specific purpose.

NCA projects are performed within Pharmetheus’ Reproducible Reporting Environment, including scripted data set generation and analysis to ensure quality and reproducibility throughout the process.

When performed within Pharmetheus’ Reproducible Reporting Environment, the NCA can rapidly be extended to a pharmaco-metric model to leverage early clinical results.

NCA projects can be performed as stand-alone analyses or as part of a long term clinical pharmacology strategy.

With 7 days from delivery of source data to delivery of a submission ready report, the NCA at Pharmetheus is a cost efficient analysis of excellent scientific quality.

PC: Pharmacokinetic concentrationsEX: ExposuresDM: Demographics

Report

Data managementSource data

QC CHECK

FiguresTables

NCAPharmacokinetic parameters

ListingsEX

DM

PCNCADATA

Integrated NCA/Reproducible Reporting Environment

At Pharmetheus, we are dedicated to efficient drug development and contribute through the performance of fit for purpose analyses across the full product life-cycle. The non-compartmental analysis (NCA) is a cost effective tool allowing for a rapid readout of pre-clinical and early clinical data. When performed within Pharmetheus’ Reproducible Reporting Environment, the NCA can rapidly be extended to a pharmacometric model to leverage early clinical results.