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01-11-2021 (Online Course)

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Online Course:
Fundamentals of Pharmacokinetics (PK) for the Non-Specialist

Understand how PK data is used in drug development to improve regulatory submission efficiency

6-week online course
1 November – 13 December 2021

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overview

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.

What Will You Learn?

  • 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

Who Should Attend?

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

trainer

Dr. Stefano Persiani

Director of Translational Sciences and Pharmacokinetics, Rottapharm Biotech, Italy

pricing

Packages Price
Online Course$1659+GST

Great Savings when you book 4 or more participants! Call us today on 02 9080 4395 or email training@informa.com.au to take advantage of this offer.


Important • Live Online Training bookings
For Live Online Training bookings, please read below before proceeding:

  • All delegate registrations must use their own email address to ensure each delegate receives a unique password to join the digital event. You cannot use one email for multiple profiles.
  • If your company is not based in Australia, check the GST box on the next page as you are not required to pay GST.

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.

Course Outline

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

01 Nov 2021

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.

contact

Still have a question?

Sushil Kunwar
Training Consultant
+61 (0)2 9080 4395
Sushil.Kunwar@informa.com

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