Population PK Analysis
Population Pharmacokinetic (PK) analysis focuses on understanding how drugs are absorbed, distributed, metabolized, and excreted across diverse patient populations.By evaluating data from varied patient demographics, this service allows:
• Customization of dosing regimens tailored to individual needs.
• Identification of sources of variability, such as age, weight, comorbidities, or genetics.
• Prediction of drug behavior in special populations (e.g., pediatrics, elderly, or renal-impaired patients).
Exposure-Response Analysis
Exposure-response analysis identifies and quantifies the relationship between drug concentrations in the body and their therapeutic or adverse effects. Key benefits include:
• Determination of optimal dosing regimens to maximize efficacy while minimizing toxicity.
• Insights into the therapeutic window of a drug.
• Support for labeling decisions and treatment guidelines.
Non-Compartmental Analysis (NCA)
Non-compartmental analysis is a straightforward and efficient method for calculating pharmacokinetic parameters without assuming a specific compartmental model. Key applications include:
• Providing critical PK parameters such as half-life, clearance, and area under the curve (AUC).
• Supporting regulatory submissions by presenting transparent and reproducible PK results.
• Informing early-phase clinical development strategies.
Study Design and Protocol Review
This service offers expert consultation to design and optimize clinical trial protocols. Expertise includes:
• Developing trial objectives, endpoints, and inclusion criteria aligned with regulatory requirements.
• Ensuring trial designs incorporate appropriate PK/PD assessments.
• Addressing challenges such as sample size estimation, biomarker selection, and ethical considerations.
Dose Selection and Optimization
Through advanced modeling and simulation techniques, this service helps guide optimal dose selection by:
• Integrating population PK/PD modeling with clinical trial data.
• Exploring the impact of various dosing regimens on drug exposure and therapeutic outcomes.
• Supporting dose adjustments for special populations or in cases of drug-drug interactions.
Pediatric Simulation
This service applies state-of-the-art pharmacometric modeling to address the unique challenges of pediatric dosing. Highlights include:
• Bridging adult data to pediatric populations using allometric scaling and physiology-based PK (PBPK) models.
• Simulating various dosing scenarios to identify the safest and most effective pediatric regimens.
• Aligning dosing strategies with regulatory guidelines for pediatric drug development.
Clinical Pharmacology and PMX
Clinical pharmacology and pharmacometrics (PMX) solutions are tailored to address specific challenges in drug development and clinical practice. These include:
• Supporting first-in-human (FIH) studies through model-informed dose selection.
• Informing drug-drug interaction (DDI) studies and relative bioavailability assessments.
• Providing actionable insights through detailed exposure-response analyses and scenario-based simulations.