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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 crucial when designing clinical trials or preparing a drug submission dossier.
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 and interpret the work of PK/PD scientists.
Understand key principles of pharmacokinetics/pharmacodynamics, including: Absorption, distribution, metabolism and excretion.
Review important concepts such as: Volume of distribution, plasma protein binding, clearance and elimination half-life
Examine and understand regulatory requirements so you know what regulators want to see
Understand how PK/PD data can influence decision making during drug discovery and drug development
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
Examine PK/PD for biological drugs to appreciate the differences from small molecules
What is Included in a Live Online Course?
Direct access to an expert trainer
Interactive and engaging sessions with exercises and discussions
Bitesize learning
Access to the Educo Life Sciences Training Portal
Unlimited access to the recordings for 4 to 5 weeks after the last session
Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
A validated certificate of attendance available for you to download
Register For Free Online Session
There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
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
Introductory Module 1
FREE to Attend | Live & Recorded
Sign up
15 May 2023 | 60 mins | 1:00 PM UK
Fundamentals of pharmacokinetics
Role of PK
Absorption
Distribution
Metabolism
Excretion
Disposition
Register For Module 1 | Free
There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
Module 2
12 June 2023 | 90 mins | 1:00 PM UK
Pharmacokinetic analysis
First and Zero Order Processes
Non-compartmental Analysis
Compartmental Analysis
Elimination Half-life
Clearance
Volume of Distribution
Case study
Module 3
13 June 2023 | 90 mins | 1:00 PM UK
Drug-Drug interactions
Definitions of drug interactions
Drug metabolism
Enzyme inhibition and induction
Reaction phenotyping
Study design
Transporter interactions
Case study
Module 4
14 June 2023 | 90 mins | 1:00 PM UK
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
15 June 2023 | 90 mins | 1:00 PM UK
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
16 June 2023 | 90 mins | 1:00 PM UK
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 Online Module and Pricing
Module 1 is free to attend and is delivered online and is recorded.
To enrol onto module 1, please submit your details in the form.
Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
There are price tiers for this course. The dates of these are at the located above the course overview.
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.
Complete our contact form by following the link. Get in touch.
*
• 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.
