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Applied Pharmacokinetic and Pharmacodynamic Study Design Course & Certification
Intermediate
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3 hours
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Applied Pharmacokinetic and Pharmacodynamic Study Design
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About
Applied Pharmacokinetic and Pharmacodynamic Study Design training provides a practical overview of the principles, methods, and regulatory considerations involved in designing and evaluating PK/PD studies throughout pharmaceutical development. It helps learners understand how pharmacokinetic and pharmacodynamic evidence supports dose selection, formulation development, bioequivalence, clinical development, and regulatory decision-making.
This Applied Pharmacokinetic and Pharmacodynamic Study Design Course & Certification covers PK/PD principles, study design, dose selection, sampling strategies, bioavailability and bioequivalence, food-effect studies, drug–drug interactions, population PK, exposure–response relationships, biomarkers, covariates, variability, PK/PD modelling, data interpretation, and regulatory expectations. Upon successful completion, learners receive a certification demonstrating their understanding of applied PK/PD study design principles and practices.
Who Should Enrol?
- Clinical Pharmacology and Pharmacokinetic/Pharmacodynamic Professionals
- Clinical Development and R&D Professionals
- Regulatory Affairs and Clinical Research Professionals
- Biostatistics and Pharmacometric Professionals
- Medical Affairs and Drug Development Teams
- Pharmaceutical Scientists and Formulation Development Professionals
- Life Sciences, Pharmacy, Medicine, and Biomedical Graduates
- Anyone seeking practical knowledge of PK/PD study design and its application in pharmaceutical development
What you will learn
Understand the fundamentals of pharmacokinetics and pharmacodynamics, including drug absorption, distribution, metabolism, excretion, drug exposure, pharmacological response, and key PK/PD parameters.
Learn how to design PK/PD studies, including dose selection, sampling strategies, single- and multiple-dose studies, bioavailability and bioequivalence, food-effect, and drug–drug interaction studies.
Develop practical knowledge of population pharmacokinetics, exposure–response relationships, pharmacodynamic biomarkers, covariate assessment, variability, and PK/PD modelling and data interpretation.
Gain an understanding of regulatory expectations and practical considerations for designing, evaluating, documenting, and applying PK/PD studies to dose selection, clinical development, and regulatory submissions.
Course Syllabus
- Where this course starts, and the map in one screen
- ICH M10 and ICH M12: the stable one and the divided one
- ICH M13A, and the guideline that survived it
- The pipeline: a draft, a concept paper, and two target dates
- ICH M15 and ICH E11A: the newest documents on the map
- Guidance, law, and the United Kingdom
- Writing the Sampling Schedule
- Four Ways a Schedule Fails
- Rich Against Sparse
- The Starting Dose
- Escalation Architecture
- The Multiple-Dose Part
- Crossover Against Parallel
- Bioequivalence: the design that answers the question
- Where the European Union and the FDA move apart
- Drug interactions: the cut-offs, and the study they trigger
- Cardiac safety: the thorough QT study, and its substitute
- Renal and hepatic impairment: study or covariate analysis
- Paediatrics, the elderly, obesity and pregnancy
- The assay as a design decision
- Reanalysis, and the validations you plan or inherit
- Exposure, response, and which question you asked
- Model-informed development under ICH M15
- Sizing a study you cannot be certain about
- Defending the package
- What governs, from when, and where the UK differs
- The two places one global study satisfies neither region
- A design standard that was correct on the day it was written
- A protocol whose escalation decision arrives before its data
- Four design decisions, each reaching for the wrong design
- The study that ran perfectly and produced unusable data
- The design decisions, in the order you actually face them
- What to do when you get back to your own programme
- The six things most likely to have changed since verification
- Five Things to Take From This Course
- 📘 Bonus: Applied Pharmacokinetic and Pharmacodynamic Study Design eBook (Free with purchase)
Course Benefits
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Gain Continuing Professional Development (CPD) Points on completion of this applied pharmacokinetic and pharmacodynamic study design course.
Certification
Build practical PK/PD study design skills — a basic understanding of pharmacokinetics or pharmacodynamics is helpful, but no advanced maths or modelling experience is required.
Affordable
Finish with practical skills you can apply to design, evaluate and interpret PK/PD studies across clinical development.
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