Population PK

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