Clinical Pharmacology

Biopharma R&D

Clinical Pharmacology is a discipline that aspires to maximize the therapeutic’s efficacy without leading to adverse events and in certain scenarios aids in identification of the appropriate patient population where the therapeutic will have maximal effect. Clinical pharmacologists work towards enhancing patient care by identifying the optimal use of a certain therapeutic, while developing a more comprehensive understanding of the intended efficacy and adverse events both short term and long term.

At Vantage, our M&S approach towards Clin Pharm have focused on the following aspects

Establish Proof of Mechanism
Connecting the mechanistic model to the clinical PD outcomes
Identify optimal Recommended Phase 2 Dose (RP2D)

Keys Questions that M&S can address

Explore hypotheses that explain observed data
Map known mechanism of action to measured biomarkers and support proof of mechanism
Simulate dose regimens and optimize the recommended Phase 2 dose
Dosing regimen recommendation for dose fractionation studies
Clinical PK-PD prediction