Clinical Pharmacokinetics and Clinical Dose Regimen Design
Clinical Pharmacokinetics and Clinical Dose Regimen Design
We provide specialized fee-for-service expertise in clinical pharmacokinetics and model-informed dose regimen design to support precision drug therapy in research and clinical practice.
Protocol & Study Design Consultation
Gain guidance from early-phase trials to investigator-initiated studies on PK sampling strategies, study protocols, and dose selection. We ensure alignment with regulatory expectations and best practices in clinical pharmacology.
PK Modeling & Simulation
Utilize tools such as Monolix and Simcyp to simulate drug exposure, evaluate variability, and inform trial design. Our modeling capabilities include population PK, physiologically based PK (PBPK), and Bayesian forecasting.
Model-Informed Dose Optimization
Get designed individualized and population-based dosing strategies using state-of-the-art pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) models. Our team supports a wide range of therapeutic areas, including infectious diseases, oncology,
Therapeutic Drug Monitoring (TDM) Support
Receive assistance with the interpretation of drug concentration data, timing of sample collection, and clinical decision-making for TDM. We have also recently advanced methods for volumetric absorptive microsampling to support pediatric PK studies. Our expertise is particularly valuable for drugs with narrow therapeutic indices or complex PK.
Specific Population Expertise
Tailored dosing strategies for patients with altered physiology—such as those with obesity, renal or hepatic impairment, critical illness, or pediatric populations—where standard dosing may be inappropriate.