Accelerate Development, Mitigate Risk

Pharmacometrics transforms complex pharmacokinetic/pharmacodynamic (PK/PD) data into powerful insights—helping you design smarter studies, select optimal dosing, and accelerate development. By applying sophisticated mathematical modeling grounded in biology, pharmacology, and physiology, we help you understand and predict how your drug behaves in the body—across diverse populations and stages of development. Our expert team leverages advanced modeling and simulation techniques to inform dose selection, streamline clinical study design, and support a more efficient path to regulatory success.

Whether you’re designing a first-in-human (FIH) study or planning for late-stage trials, we provide the strategic insight you need to move forward with confidence—avoiding unnecessary studies, saving time, and reducing costs.

Foundational PK Analysis

We build your program on solid PK data using noncompartmental (NCA) PK analysis. These precise PK evaluations support early-phase decisions and regulatory requirements.

Advanced Modeling and Simulation

Our team applies population-based and mechanistic models to simulate drug behavior and support optimal study design to predict outcomes, guide dosing, and streamline development.

• Population PK/PD modeling and simulation
• Dose-exposure relationship analysis
• QTc study design and simulations
• Clinical trial design evaluation and refinement

Dose Selection and Optimization

Inform smarter dosing decisions across all phases. We help you identify effective, safe doses for target populations using a data-driven, model-informed approach.

• FIH dose selection
• Dose and regimen selection for Phase 2 and Phase 3 studies
• Dose-exposure relationship analysis

Special Population Strategy

Safety is critical—we’ll help you confidently navigate dosing in high-risk or underrepresented groups to ensure your drug is safe and effective for all relevant populations.

• Dose adjustments for special populations (renal, hepatic, elderly)
• Pediatric PK modeling using allometric scaling

Translational & Predictive Modeling

Leveraging interspecies scaling to mitigate risk in FIH studies and streamline progression, we’ll help you bridge preclinical findings to clinical application.

• Interspecies scaling for FIH dose estimation
• Pediatric PK modeling using allometric scaling

PK Sampling Optimization

We’ll maximize data value while minimizing patient burden by designing efficient sampling strategies to capture critical data with fewer samples.

• PK sampling strategy optimization (sparse and intense sampling)
• Sparse PK sample analysis

Our Approach in Action: Case Studies

Case Study: Leveraging Data from an Approved Drug to Eliminate Clinical Studies for a New Product

• Our Objective: To demonstrate the same efficacy for two drugs (one approved and one new) with similar total exposure but different PK profile curves.
• Our Approach: We evaluated the efficacy of the new drug by assessing and comparing the levels of PD biomarker. PK data was used to model and correlate the concentration data with the profile of the PD biomarker allowing to assess efficacy by modeling the exposure-response relationship.
• The Outcome: The maximum PD marker levels, minimal concentration (C_min) for effect and Area Under the Effect Curve (AUEC) were comparable between the new drug and the approved drug.

As a result of successful modeling, the sponsor did not have to invest in additional bridging studies. It was determined that safety and efficacy data from studies of the approved drug to be used to support approval of the new drug, thus reducing the scope of the clinical program and supporting a more efficient development plan.

Case Study: Optimizing Clinical Efficacy Through Alternative Route of Administration Using PK/PD

• Our Objective: To determine the drug administration route providing the best efficacy outcomes.
• Our Approach: We developed population PK/PD model to determine the lower and upper concentration thresholds correlated with the clinical effect for different routes of administration, dose levels, and patient health conditions.

We determined that developed population PK/PD model demonstrated differential exposure for intravenous (IV), oral, and subcutaneous (SC) routes of administration. SC administration was determined to provide the most favorable exposure profile that maximized efficacy under the widest range of conditions with the prolongated time above the concentration of clinical threshold.

Why Choose Premier?

• Experienced Experts and Functional Teams. With decades of experience, we bring deep scientific expertise in PK/PD modeling, simulation, and regulatory strategy to support your success.
• Data-Driven Decisions. We package quantitative insight to guide your development program and inform decision making.
• Regulatory Alignment. Expert-led pharmacometrics strategies are informed by regulatory, clinical, and commercial specialists to support asset development and approval by global health authorities.

Contact Premier today to transform your program with actionable, data-drive insight.