Advanced Pharmacokinetics & Pharmacodynamics Consulting

Understanding how drugs move through the body and produce their effects is fundamental to successful drug development and clinical practice.

As a specialized PK/PD consultant, I help pharmaceutical companies, researchers, and clinical teams translate complex drug behavior into actionable insights for dose optimization and therapeutic decision-making.

Whether you’re developing new compounds, optimizing existing therapies, or conducting clinical pharmacology studies, my expertise ensures your PK/PD analyses are scientifically rigorous and regulatory-compliant.

Comprehensive PK/PD Services

Transform your drug concentration and response data into clear therapeutic insights.

My end-to-end pharmacokinetics and pharmacodynamics services help organizations understand drug behavior from absorption to effect, supporting informed decisions throughout the drug development lifecycle.

Population PK/PD Modeling

Build robust models that capture drug behavior across diverse patient populations.

  • Develop nonlinear mixed-effects models using NONMEM, Phoenix, and R
  • Characterize PK parameters including clearance, volume of distribution, and bioavailability
  • Analyze covariate effects on drug exposure and response
  • Model complex absorption processes including first-pass metabolism
  • Quantify between-subject and within-subject variability
  • Validate models through visual predictive checks and simulation studies

ADME Analysis & Compartmental Modeling

Comprehensive analysis of drug absorption, distribution, metabolism, and excretion.

  • Conduct compartmental analysis for time-concentration profiles
  • Determine drug half-life, clearance rates, and steady-state concentrations
  • Analyze bioavailability and bioequivalence studies
  • Model drug metabolism pathways and metabolite kinetics
  • Characterize tissue distribution and protein binding
  • Evaluate elimination mechanisms and renal clearance

Dose-Exposure-Response Optimization

Link drug concentrations to therapeutic outcomes for optimal dosing strategies.

  • Establish exposure-response relationships for efficacy and safety endpoints
  • Design dose optimization studies using PK/PD simulation
  • Develop therapeutic drug monitoring protocols
  • Analyze PD endpoints in relation to drug exposure
  • Model time-dependent and concentration-dependent effects
  • Support dose selection for special populations

Clinical Pharmacology Support

Comprehensive support for clinical pharmacology studies and regulatory submissions.

  • Design and analyze first-in-human PK studies
  • Conduct food effect and drug-drug interaction analyses
  • Support regulatory submissions with model-based summaries
  • Develop clinical pharmacology sections for regulatory documents
  • Provide expert consultation on study design and protocol development
  • Create comprehensive clinical pharmacology reports

PK/PD Integration & Simulation

Seamlessly integrate pharmacokinetic and pharmacodynamic data for comprehensive drug characterization.

  • Develop integrated PK/PD models linking exposure to response
  • Conduct PK/PD simulation studies for dose selection
  • Analyze PK/PD variability sources and clinical implications
  • Model complex dose-response relationships
  • Support go/no-go decisions with quantitative evidence
  • Design optimal sampling strategies for PK/PD studies

Ongoing Support & Training

Beyond initial analysis, I provide:

  • Model validation and regulatory review preparation
  • Training on PK/PD modeling software and methods
  • Support for follow-up studies and model updates
  • Strategic guidance on PK/PD study design
  • Expert consultation on complex modeling challenges
  • Documentation support for regulatory submissions
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Why Work With Me For Your PK/PD Needs?

Working with a PK/PD specialist benefits you in many ways

Time Efficiency

Focus on drug development strategy while I handle complex PK/PD analyses and modeling.

Reduced Stress

Navigate regulatory requirements and complex modeling challenges with expert guidance and support.

Accurate Results

Use industry-standard methods and software with rigorous statistical approaches. My expertise in nonlinear mixed-effects modeling and population PK ensures reliable, defensible results.

Use Results With Confidence

Your PK/PD models will meet regulatory standards and provide clear insights for dose optimization. Results directly support clinical decision-making and regulatory submissions.

The PK/PD Consulting Process

My consulting process is designed for pharmaceutical industry needs

Discovery Phase

We discuss your PK/PD objectives, study design, data availability, and regulatory requirements. I assess your specific modeling needs and timeline constraints.

Project Plan and Model Strategy

Together, we establish the project scope, modeling approach, and deliverables. You receive a detailed Service Proposal outlining methods, timeline, and costs. We finalize the analysis plan and model specifications.

Data Analysis and Modeling

I conduct comprehensive PK/PD analyses using industry-standard software. I handle complex issues like sparse sampling, missing data, and population heterogeneity while maintaining model identifiability.

Deliverables

You receive detailed modeling reports with publication-ready figures, model diagnostics, and regulatory-compliant documentation. All analyses include comprehensive methodology sections and model validation results.

For urgent questions, my on-demand consultation service offers quick, cost-saving solutions.

Book Express Consultation

Case Studies

I worked on large medical datasets to answer causal questions related to epidemiological determinants of disease through complex exposures. Challenges included selection bias, confounding, and missing data. I successfully developed a strategy that gave researchers confidence in their results.
I’ve worked with R&D scientists who were simultaneously running multiple experiments to answer important questions about their cutting-edge products that would have a direct impact on various stakeholders. My role was to help in designing and analyzing the experiments, balancing the conceptual purity of the Design of Experiments theory (DoE) with pragmatic concerns relating to costs and timeline. Most of this work is sealed behind a Non-Disclosure Agreement (NDA) which prevents me from elaborating more.

Don’t Just Take My Word For It…

The positive experiences of my happy collaborators showcased through their glowing testimonials, serve as powerful proof of trustworthiness and the impact of the results I deliver. These testimonials offer real-life examples of how I’ve helped research projects succeed. Here are some of their thoughts:

5/5

"He has a deep understanding of statistics, yet is able to skillfully explain complex concepts to people with little-to-no background in statistics both in French and English."

Elsa Brunet-Ratnasginham

Post-doc, UCSF

5/5

"I had never before worked with a biostatistician who speaks the same language as me! [...] Personally, our collaboration has allowed me to reconcile with statistics."

Manon Nayrac

Post-doc, CRCHUM

5/5

"I highly recommend Justin and his team for your data processing needs in order to have a more robust statistical model than the tests we are accustomed to conducting as biologists!"

Gérémy Sannier

Ph.D candidate, CRCHUM

5/5

"Thanks to him, statistics appeared to me as solutions rather than obstacles."

Mathieu Dubé

Research Associate, CRCHUM

Read Full Collaborator Testimonials
Justin Belair - Causal Inference Expert

My Statistics and Causal Inference Expertise

As a university-level statistics lecturer with a substantial LinkedIn following, scientists from all over the world come to me for my unique combination of academic excellence and practical experience in statistics and causal inference.

I’ve applied causal inference methods in varied settings in both academia and industry: in biomedical sciences such as nephrology, immunology, neuroscience, virology, occupational therapy, epidemiology, dermatology, psychiatry, and oncology; in natural sciences such as agronomy, ecology, and zoology; and social sciences such as communication, and psychology. The list keeps on growing!

I am currently writing an advanced textbook that I hope will give a young generation of academic and industry researches the tools needed to grapple with the complexities of causal inference, and maybe even develop a passion for the subject!

Need help with PK/PD analysis? From study design to complex population modeling, I offer specialized expertise for pharmaceutical development. Together, we can optimize your drug development program and regulatory strategy.

Let's Talk

Tools and Technologies

Using industry-standard PK/PD software including NONMEM, Phoenix WinNonlin, and R, I ensure your analyses meet regulatory expectations and scientific standards.

I leverage specialized packages for population PK/PD modeling, including nlme, SAEM algorithms, and Bayesian methods for complex model fitting and simulation studies.

I'm experienced with all major pharmaceutical analysis platforms: SAS for regulatory submissions, MATLAB for custom modeling, and specialized PK/PD software for method development.

Client Industries Served

My statistical consulting expertise extends beyond specific industries, serving clients in fields ranging from R&D in biotechnology and pharmaceuticals to researchers and Principal Investigators (PI) in academia.