Understanding Pharmacokinetics for the Non-Specialist

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  • Individual/Group
  • Individual
  • Group or Team

 

If you would like training for yourself or a group, complete the form above

Course Overview

 

Pharmacokinetics is an important discipline, imperative to the development of new medicines. Pharmacokinetic and pharmacodynamic data is gathered throughout drug development and is often difficult to understand.

This training course provides you with knowledge of the core aspects of pharmacokinetics, so you perform with confidence in your role. You will learn important definitions, how to analyse pharmacokinetic data, the relationship between pharmacokinetics and pharmacodynamics, drug-drug interactions and regulatory requirements. Once completed you will have the knowledge to communicate with PK/PD scientists, capable of interpreting their work.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

 

  • Understand key principles of pharmacokinetics/pharmacodynamics, including: absorption, distribution, metabolism and excretion.
  • Examine and understand regulatory requirements so you know what regulators want to see
  • Consolidate your knowledge with case studies and understand the relevance of pharmacokinetics in practice
  • Analyse pharmacokinetics within large molecules (biopharmaceuticals)
  • Review key definitions, data analysis and regulatory expectations: The fundamentals of PK/PD
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Module 1

| 60 mins

Fundamentals of pharmacokinetics

  • Role of PK
  • Absorption
  • Distribution
  • Metabolism
  • Excretion
  • Disposition

 

Module 2

| 90 mins

Pharmacokinetic analysis

  • First and Zero Order Processes
  • Non-compartmental Analysis
  • Compartmental Analysis
  • Elimination Half-life
  • Clearance
  • Volume of Distribution
Module 3

| 90 mins

Drug-Drug interactions

  • Definitions of drug interactions
  • Drug metabolism
  • Enzyme inhibition and induction
  • Reaction phenotyping
  • Study design
  • Transporter interactions

 

Module 4

| 90 mins

Regulatory guidelines

  • PK Results Presentation
  • Individual and mean PK Profiles
  • Variability in PK
  • Crossover Study design
  • Statistical Analysis
  • Sample Size Calculation
  • First In Man Guideline

 

Module 5

| 90 mins

PK/PD studies

  • Single and Multiple Dose PK Studies
  • Linear PK
  • Absolute and Relative Bioavailability, Bioequivalence
  • Food Effect study
  • Biomarkers
  • Direct vs Indirect PK/PD
  • Hysteresis
Module 6

| 90 mins

Pharmacokinetics of biologics & population pharmacokinetics

  • Definitions of Biological Drugs
  • Biological Drugs ADME
  • PK of Biological Drugs Guideline
  • Fundamental of Population PK
  • Role of Population PK
  • Application of Population PK

 

Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. After years working in academia, Dr. Persiani moved to the pharmaceutical industry and CRO sector holding different positions always applying pharmacokinetic approaches in R&D at Farmitalia Carlo Erba, Pharmacia, Upjon, and Zambon Group.

 

His experience within pharmaceutical companies and CROs includes the assessment of pharmacokinetics, drug metabolism, and drug-drug interactions during drug discovery for lead optimization and in preclinical as well as in clinical pharmacology during drug development. He has experience addressing pharmacokinetic issues for drugs and biologics under development in different therapeutic areas including oncology, respiratory, CNS, anti-infective, cardiovascular, gastrointestinal, and rheumatology. In these therapeutic areas, he applies translational, PK/PD prediction, and modelling strategies for candidate selection and to obtain the proof of concept of efficacy and safety in preclinical models as well as during clinical trials in the target patient populations. Dr. Persiani regularly interacts with regulatory authorities and acts as peer reviewer of scientific articles in the field of pharmacokinetics and clinical pharmacology.

This course is aimed at anyone who interacts with PK/PD data but does not require specialist knowledge in the field. No previous knowledge of PK/ PD is assumed.

 

Relevant departments include:

  • Regulatory Affairs
  • Research & Development
  • Preclinical Development
  • Licensing & Business Development
  • Clinical Operations
  • Clinical Pharmacology

 

Free First Module and Pricing
  • Module 1 is free to attend for this live online course and is delivered a few weeks before the start date.
  • To enrol onto module 1, please submit your email at the top of the page.
  • All sessions are recorded. If you are unable to attend module 1, you can catch up ahead of the course start date.
  • You will receive a Super Early Bird discount if you purchase the course before module 1.
  • If you decide to purchase the course after module 1, but before the start date you will receive an Early Bird Discount.
  • To sign up to the free first module provide your email address in the form at the top of the page

Frequently asked questions (FAQs)

 

 

 

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.