Pharmacokinetic (PK) and Pharmacodynamic (PD) Analysis
A dedicated team of pharmacokinetic (PK) scientists is ready to support your study from start to finish with our extensive experience across the full spectrum of clinical pharmacology studies, from first-in-human to proof-of-concept.
Our pharmacokinetics team is integrated throughout the study, from consultation on study design through execution of PK/PD analyses and clear reporting of results, so sponsors receive timely, reliable data to support drug development. Services include:
Study design/protocol development support
Pharmacokinetic/PD analysis plan (or integrated statistical analysis plan)
Interim and topline PK/PD analysis
Noncompartmental PK/PD analysis
Integrated Model-Informed Drug Development (MIDD) Strategies Leveraging Population PK, PK/PD, and Modeling & Simulation to Inform Dose Selection, Trial Design, and Clinical Development Strategy
Risk mitigation using physiologically-based pharmacokinetics (PBPK) in Drug-drug interaction (DDI) studies, food effect, ethno-bridging, organ impairment and pediatric dose prediction
Volunteer evaluability assessments
Expedited interim and topline analyses that support dose escalation and other time-sensitive decisions
Datasets and table, listing and figure outputs, in collaboration with biostatistics and statistical programming teams
PK/PD text for incorporation into Clinical Study Reports (CSRs) or PK reports
Experience snapshot
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Years combined PK team experience
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Studies supported since 2024
Our PK/PD analysis approach
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Quality and accountability
Every project is supported by a dedicated team with quality and accountability built into the work from the start. Our pharmacokineticists/pharmacometricians consult on study design and PK/PD analysis planning, then carry that planning through execution. By staying engaged throughout, we are able to identify risks and circumvent issues quickly, avoiding timeline delays and ensuring study objectives are met.
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Collaboration
By working closely with biostatistics, programming, data management and medical writing team members, we are able to navigate transitions seamlessly. We also collaborate closely with our sponsors to ensure our work is always in line with expectations.
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Data integrity
We offer standard CDISC-compliant noncompartmental analyses as well as modeling and simulation approaches to help shape dose selection, clinical study design and drug development strategies. Our PK and modeling/simulation teams are closely integrated and use cutting-edge technology to increase efficiency and maintain data integrity.
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Expedited interim and topline analyses
For programs where decisions cannot wait, we provide expedited interim and topline analyses that support dose escalation and other time-sensitive decision-making.
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PK/PD Interpretation
When the analysis is complete, our experts generate and review the PK/PD text for Clinical Study Reports. We communicate complex clinical pharmacological findings to key decision-makers in a clear, actionable manner, and we deliver results that are accurate, well-documented and transparent enough to support confident decisions.
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Ad hoc consulting
Ad hoc consulting services are also available, including support for study design considerations and regulatory interactions, such as briefing books and response letters.
Our PK/PD analysis leadership
Backed by decades of combined experience, our team supports programs from first-in-human studies through proof-of-concept. Working collaboratively across study design, analysis, modeling and reporting, they help sponsors generate reliable data and make informed development decisions.
Standard noncompartmental PK/PD analyses are performed in Phoenix WinNonlin, (Certara USA, Inc.) in the vendor’s hosted and validated environment. We primarily use NONMEM (via Pirana) and R for modeling and simulation and PK-Sim (and Mobi) for physiologically-based pharmacokinetics (PBPK) modeling. Software is used in combination with Integral (a 21 CFR Part 11-compliant data and model repository) for full regulatory compliance. Partner licenses are available to sponsors upon request, for direct access to the repository.
Quality, standards and compliance
Quality is built into every aspect of our work.
Peer reviews
Analyses, text and deliverables are peer reviewed (and/or validated) to support scientific and regulatory confidence.
Regulatory compliance
We utilize Integral (a 21 CFR Part 11-compliant data and model repository) for model and data analysis tracking, supporting full regulatory compliance.
Workflow Efficiency
Ongoing process improvements keep the analysis and reporting workflow efficient while maintaining those standards. We make sure our work and recommendations are in line with regulatory guidance, best practices and scientific and ethical standards.
Connected across the full study lifecycle
PK/PD analysis connects directly to the functions that produce and use the data. Careful compliance to protocol specifications keeps variability to a minimum and sample collections in our Phase I unit are built for the precise timepoints PK studies require. Accurate and complete data collection from our data management team is crucial to ensure objectives can be met at the end of the study. Clean, structured datasets and the associated outputs from our biostatistics and programming team feed into and out of the PK/PD analyses, with the safety data alongside it.
Our experts collaborate with medical writing by providing PK/PD text for Clinical Study Reports. In support of model-informed drug development, our PK modeling and simulation services extends this work further. Your Project Manager coordinates these handoffs across the full study lifecycle.
Featured study
Challenge
A sponsor needed to de-risk a pivotal bioequivalence assessment for a product with a long half-life that had not been adequately characterized in previous studies. The program required additional pharmacokinetic data to support critical development decisions while preserving study blinding.
Approach
We provided study design support, coordinated expedited bioanalytical testing and delivered rapid interim PK analyses following each cohort. Close collaboration between project management, bioanalytical partners and PK scientists enabled timely review of blinded concentration-time data and exposure results to support sponsor decision-making.
Outcome
Rapid turnaround of PK samples and analysis identified higher-than-anticipated exposure and an emerging safety signal early in development. De-identified concentration-time data enabled the sponsor to evaluate exposure variability while maintaining study blinding, ultimately supporting an informed dose adjustment decision and continued characterization of the investigational product.
Talk to a team that turns PK data into confident drug development decisions.
From first-in-human to proof-of-concept, our dedicated team of PK scientists/pharmacometricians with robust experience in the industry are available to support PK/PD studies, from study design to planning and execution of PK/PD analyses and reporting of results. Consultation on MIDD as well as expedited interim and topline reporting options are also available to support timely decision-making.
