Pharmacometrics

Case Studies

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Submission Support – PK & PK/PD

High Quality, Efficiency & Compliance

Therapeutic Window Determination

Or how to turn a Phase 2 a dose selection into an early NoGo decision

Label Extension
[505(b)(2) Strategy]

More flexible SC dosing regimen desired

Animal to human PK translation

Informed FIH dose selection

Phase IIb Design

Confident transition to full development

Reproducible Analyses

Computation without Borders and Reproducible Analyses: IQ Desktop

R based PK/PD modeling workflow

We helped a client leverage the power of open-source modeling tools for internal modeling and simulation tasks