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overview
Key Learning Objectives
- Familiarise yourself with the key principles of Pharmacokinetics, including absorption, distribution, metabolism and excretion.
- Understand how to present Pharmacokinetic results to the regulators.
- Consolidate your knowledge with case studies and understand the relevance of Pharmacokinetics in practice
- Address the fundamental areas of PK, including definitions, data analysis and regulatory expectations.
About the Course
Pharmacokinetics is an important discipline, imperative to the development of new medicines. With no prior knowledge assumed, this six-module course will familiarise you with the core aspects of pharmacokinetics. You will learn important definitions, how to analyse pharmacokinetic data, the relationship between pharmacokinetics and pharmacodynamics, drug-drug interactions and regulatory requirements. On top of this, you will be able to consolidate your knowledge with two case studies, both detailing practical uses of pharmacokinetics.
Who Will Benefit
This course is aimed at anyone who comes into contact with PK/PD data but does not require specialist knowledge in the field. No previous knowledge of PK/PD is assumed.
Relevant Departments include:
- Research & Development
- Preclinical Development
- Licensing & Business Development
- Clinical Operations
- Regulatory Affairs
- Clinical Pharmacology
Benefits of Learning Online
Informa Corporate Learning’s online courses are new digital, interactive and engaging educational experience designed to maximise learning for professionals with busy schedules and/or small training budgets.
Our online courses are perfect opportunity for busy professionals as they require just 2 hours per week of your time and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis, so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
Agenda
Module 1: Fundamentals of Pharmacokinetics
Learning Outcomes
- Role of PK
- Absorption
- Distribution
- Metabolism
- Excretion
- Disposition
Module 2: Pharmacokinetic Analysis
Learning Outcomes
- First and Zero Order Processes
- Non-compartmental Analysis
- Compartmental Analysis
- Elimination Half-life
- Clearance
- Volume of Distribution
Module 3: Drug-Drug Analysis
Learning Outcomes
- Definitions of Drug Interactions
- Drug Metabolism
- Enzyme Inhibition and Induction
- Reaction Phenotyping
- Study Design
- Transporter Interactions
Module 4: Regulatory Guidelines
Learning Outcomes
- 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: PK/PD Studies
Learning Outcomes
- 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: Pharmacokinetics of Biologics & Population Pharmacokinetics
Learning Outcomes
- Definitions of Biological Drugs
- Biological Drugs ADME
- PK of Biological Drugs Guideline
- Fundamental of Population PK
- Role of Population PK
- Application of Population PK
when & where
06 Mar 2023
Online Course
03 Jul 2023
Online Course
30 Oct 2023
Online Course
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.