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De-Risk clinical programs with a "Demonstrate Early or Quick to Kill" strategy:
De-Risk clinical programs with a "Demonstrate Early or Quick to Kill" strategy:
First in Human (FIH) approach demands careful introspection and an assessment of what it takes to “demonstrate” clinical benefit as well as business value.
First in Human (FIH) approach demands careful introspection and an assessment of what it takes to “demonstrate” clinical benefit as well as business value.
FIH strategy revolves around the triad of “CMC – Safety- Anticipated effective dose” . Current knowledge of disease characteristics in population as well as regulatory expectations influences the development strategy.
Our cross functional assessment is a tested approach with a much more illustrated roadmap with model informed (MIDD) techniques.
Clinical Development plan
Phase 1 AND 2 Strategy : Dose, regimen, patient selection
Model informed drug development (MIDD)
PBPK, PK-PD, IVIVC or formulation selection
First in human (FIH) Simulations from pre-clinical data
Virtual trial simulation, impact of Dropouts
Dose –regimen optimization
Disease progression models/Systems biology pathways linked to PK.
Creating deep scientific value for your out-licensing asset
“At Pleroo Research, we have developed FIH solutions for our clients over the last decade.. We present you technically sound, cross functional and business relevant solutions without restricting our clients to closed eco-systems or platforms. Reach out to us to know more.”
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