Pharmacokinetic and Pharmacodynamic (PK/PD) Analysis in Drug Development

Master PK/PD principles to support smarter, faster, and more confident drug development decisions.

Pharmacokinetic and Pharmacodynamic (PK/PD) Analysis in Drug Development

Master PK/PD principles to support smarter, faster, and more confident drug development decisions.

Better PK/PD insight leads to better development decisions.

Common Challenges

Many life sciences teams struggle with:

  • Understanding PK and PD drivers of drug performance

  • Interpreting concentration, exposure, efficacy, and safety relationships

  • Translating animal data into human development predictions

  • Using PK/PD software and analytical tools effectively

  • Communicating findings across scientific and regulatory teams

Our Solution

Participants learn a structured, practical approach including:

  • Interpreting core PK and PD parameters correctly

  • Applying compartmental and non-compartmental analysis methods

  • Exploring variability, covariates, and population modeling concepts

  • Evaluating tissue distribution and PBPK model applications

  • Presenting PK/PD findings for cross-functional decision-making

This course helps professionals turn complex PK/PD concepts into practical development insight across preclinical, clinical, regulatory, and quality environments.

Better PK/PD insight leads to better development decisions.

Common Challenges

Many life sciences teams struggle with:

  • Understanding PK and PD drivers of drug performance

  • Interpreting concentration, exposure, efficacy, and safety relationships

  • Translating animal data into human development predictions

  • Using PK/PD software and analytical tools effectively

  • Communicating findings across scientific and regulatory teams

Our Solution

Participants learn a structured, practical approach including:

  • Interpreting core PK and PD parameters correctly

  • Applying compartmental and non-compartmental analysis methods

  • Exploring variability, covariates, and population modeling concepts

  • Evaluating tissue distribution and PBPK model applications

  • Presenting PK/PD findings for cross-functional decision-making

This course helps professionals turn complex PK/PD concepts into practical development insight across preclinical, clinical, regulatory, and quality environments.

What You'll Learn

Comprehensive curriculum designed to help professionals interpret PK/PD data and apply regulatory-aligned scientific thinking across drug development.

PK Foundations and Core Parameters

  • Understand absorption, distribution, metabolism, and excretion principles

  • Interpret concentration-time data and key PK parameters

  • Connect drug structure with exposure and disposition behavior

PK Modeling and Data Evaluation

  • Differentiate compartmental and non-compartmental analysis approaches

  • Evaluate model fit, residuals, and statistical outputs

  • Understand variability, covariates, and population model concepts

PD and Exposure-Response Relationships

  • Define potency, efficacy, therapeutic window, and index

  • Analyze PK/PD relationships for activity and safety

  • Use effect data to support development decisions

Applied Workshop and Software Demonstrations

  • Analyze animal and human PK/PD datasets

  • Use dedicated free software for practical modeling exercises

  • Interpret results and explore commercial software capabilities

What You'll Learn

Comprehensive curriculum designed to help professionals interpret PK/PD data and apply regulatory-aligned scientific thinking across drug development.

PK Foundations and Core Parameters

  • Understand absorption, distribution, metabolism, and excretion principles

  • Interpret concentration-time data and key PK parameters

  • Connect drug structure with exposure and disposition behavior

PK Modeling and Data Evaluation

  • Differentiate compartmental and non-compartmental analysis approaches

  • Evaluate model fit, residuals, and statistical outputs

  • Understand variability, covariates, and population model concepts

PD and Exposure-Response Relationships

  • Define potency, efficacy, therapeutic window, and index

  • Analyze PK/PD relationships for activity and safety

  • Use effect data to support development decisions

Applied Workshop and Software Demonstrations

  • Analyze animal and human PK/PD datasets

  • Use dedicated free software for practical modeling exercises

  • Interpret results and explore commercial software capabilities

Who This Course Is For

Preclinical and Clinical Researchers

Build stronger skills to interpret PK/PD results and support development strategy.

Regulatory Affairs Professionals

Improve your ability to review PK/PD data in regulatory documentation.

Quality Assurance and Compliance Specialists

Strengthen scientific understanding when evaluating study outputs and data quality.

Biostatisticians and Data Scientists

Apply PK/PD analysis concepts to support more informed modeling and interpretation.

Who This Course Is For

Preclinical and Clinical Researchers

Build stronger skills to interpret PK/PD results and support development strategy.

Regulatory Affairs Professionals

Improve your ability to review PK/PD data in regulatory documentation.

Quality Assurance and Compliance Specialists

Strengthen scientific understanding when evaluating study outputs and data quality.

Biostatisticians and Data Scientists

Apply PK/PD analysis concepts to support more informed modeling and interpretation.

Meet Your Instructor

stefansky

Prof. David Stepensky, PhD

Prof. David Stepensky is a leading expert in pharmacokinetics, pharmacodynamics, PK/PD modeling, drug delivery systems, and targeted therapies. He combines deep academic expertise with practical consulting experience across pharma, biotech, and health authority environments, helping professionals translate complex PK/PD science into meaningful drug development decisions.

Areas of expertise: •Pharmacokinetics •Pharmacodynamics PK/PD •Modeling Drug Delivery •Targeted Therapies •Regulatory Consulting

  • Head of the School of Pharmacy at Ben-Gurion University

  • Published more than 60 scientific papers in the field

  • Consultant to the Israeli Ministry of Health and industry

  • Academic training includes Hebrew University, Weizmann Institute, and Yale

Meet Your Instructor

stefansky

Prof. David Stepensky, PhD

Prof. David Stepensky is a leading expert in pharmacokinetics, pharmacodynamics, PK/PD modeling, drug delivery systems, and targeted therapies. He combines deep academic expertise with practical consulting experience across pharma, biotech, and health authority environments, helping professionals translate complex PK/PD science into meaningful drug development decisions.

Areas of expertise: •Pharmacokinetics •Pharmacodynamics PK/PD •Modeling Drug Delivery •Targeted Therapies •Regulatory Consulting

  • Head of the School of Pharmacy at Ben-Gurion University

  • Published more than 60 scientific papers in the field

  • Consultant to the Israeli Ministry of Health and industry

  • Academic training includes Hebrew University, Weizmann Institute, and Yale

Course Format & Schedule

Live via Zoom

Interactive sessions with real-time Q&A and expert guidance

April 14-15, 2025

Two intensive sessions: 10:00-13:30 EST each day

7 Hours Total

Comprehensive coverage in 2 convenient half-day sessions

60-Day Replay Access

Review sessions and reference materials at your own pace

Investment & Bonuses

840$
Individual Registration
Group Rate: $739
For 3+ people from same organization
Secure your spot

Add Your Heading Text Here

Investment & Bonuses

840$
Individual Registration
Group Rate: $739
For 3+ people from same organization
Secure your spot

Exclusive Bonuses

Frequently Asked Questions

Do I need prior PK/PD experience to join this course?

No prior PK/PD modeling experience is required. The course is designed to be accessible for beginners while still offering practical value for more experienced professionals.

No. The course is also highly relevant for professionals in clinical research, regulatory affairs, quality, biostatistics, and broader drug development teams. It is especially useful for those who need to interpret PK/PD outputs and communicate findings clearly.

Yes. Participants will work through practical examples using dedicated free software and will also see demonstrations of commercial PK/PD tools. This helps connect theory with real application.

Yes. Participants receive course materials and example datasets that support learning and application after the training. The free software used in the workshop can also continue to support their work.

Still have questions?

What Professionals Say About This Course

Sarah MitchellQA/RA Director, Medical Device Company
This course finally clarified how ISO 14971 should actually be implemented in real development projects. The examples were extremely practical.
David ChenR&D Manager, Digital Health Startup
Iris explained complex regulatory expectations in a way that our entire cross-functional team could understand and apply immediately.
Michael RosenbergQuality Systems Manager, MedTech Manufacturer
The session on building a Risk Management File alone was worth the course. We improved our internal documentation process right away.
Laura GómezRegulatory Affairs Specialist, Global MedTech Company
Clear, structured, and highly relevant for companies preparing for EU MDR compliance.
Kevin PatelProduct Development Lead, Medical Device Startup
A great balance between theory and practical implementation. Our engineering team gained a much better understanding of risk analysis.
Anna BergströmSenior Compliance Manager, Life Science Company
One of the most practical trainings I’ve attended on medical device risk management. Highly recommended for QA and RA professionals.

Advance your PK/PD expertise and strengthen drug development decisions.

Join this expert-led course to build a practical understanding of pharmacokinetic and pharmacodynamic analysis, improve cross-functional communication, and apply PK/PD insight more effectively across pharma, biotech, clinical research, regulatory, and quality environments.

Expert Guidance

Ready-to-Use Templates

Accelerated Implementation

Regulatory Inspection Ready

Still have questions?