Leverage a quantitative approach to first-in-human (FIH) dose selection
Leverage a fit-for-purpose, model-informed approach to integrate non-clinical PK/PD data for first-in-human (FIH) dose selection and clinical study design. Our integrated team of DMPK and pharmacometrics consultants will support your translational strategy, including non-clinical study design, non-GLP TK analysis and reporting, translational modeling and simulation, and IND authoring.
What's included
- PK/PD Modeling
- Translation into human
- Simulation for dose selection
- Submission-ready documentation
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