ZOOM Online: Pharmacokinetics in Drug Development – an integrated approach

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This course will provide participants with a comprehensive introduction to pharmacokinetics (PK) and the principles of pharmacokinetic/pharmacodynamic (PK/PD) modelling. PK and PK/PD concepts will be considered alongside regulatory guidances to demonstrate how they can be used to deliver effective drug development programmes.

In drug development clinical pharmacology is tasked to ensure that patients receive the right dose at the right time. This ensures that the new medicine is safe and effective throughout the patient population. To achieve this goal, it is necessary to recognise the factors that can alter drug response. Knowledge of PK and PK/PD relationships is at the heart of this endeavour. For many drugs, clinical pharmacology information accounts for almost 50% of the final drug label, further emphasising the importance of PK understanding in drug development.

Throughout the course participants will learn how to apply the knowledge gained to enable them to be more effective in their professional roles.

What will participants gain-

  • Increased confidence to discuss PK issues within their drug projects
  • Understanding of the common PK terms and their importance
  • Understanding of how PK data influences the clinical development programme
  • An understanding of the factors that contribute to variability in PK
  • The role of PK/PD modelling in drug development
  • An appreciation of how regulatory guidances influence PK strategy

Course will commence with registration at 8.30am, course proper at 9.00am and will finish at 5.00pm each day.

The principle processes involved in PK will be discussed and the jargon used in their description and estimation will be explained. The application of PK in drug development will be addressed through broadly answering the following questions.

What is PK and why is it important”

  • Absorption, distribution, metabolism and elimination
  • Therapeutic windows
  • PK terminology including clearance and volume of distribution
  • PK input into study design

How are PK parameters estimated and interpreted”

  • Non compartmental Analysis
  • Compartmental modelling
  • PK/PD modelling
  • Population PK
  • Physiologically Based PK models
  • Regulatory environment
  • Data interpretation
  • Reporting

How do biologics differ to small molecules”

  • PK disposition
  • Study Design
  • Application of PK methodology
  • Variability

How is pre-clinical PK information used”

  • Candidate selection
  • Therapeutic dose estimation

What are the aims of early phase development”

  • Dose choice in first in human studies
  • Drug interactions; CYPs and transporters
  • Radiolabel studies to assess routes of elimination
  • Assessing bioavailability and bioequivalence

How does variability in PK affect the dose”

  • Pharmacogenetics
  • Demographics
  • Food effects
  • Renal and hepatic impairment

Several “learning in action” workshops during both days will provide participants with the opportunity to apply the knowledge gained during the lectures. These include interactive quizzes (with prizes!), in addition to case histories covering the application of PK principles to drug development challenges

The course is intended for all professionals in the drug development arena but does not require specialist knowledge of the subject. In particular the course will benefit professionals working in; regulatory affairs, clinical operations, medical affairs, medical writing, project management, drug safety, formulation development and data management. In essence, anyone who wishes to further their knowledge of the usefulness of PK in their projects will profit from the course.

Numbers are restricted for maximum benefit to participants

Well judged depth and diverse subject matter/topics”

“Excellent course, I learnt a lot of new facts”

“Very good interactive lectures”

“I really enjoyed the course and I liked that it went from fairly basic principles to start, then on to more complex”

This course was recommended by Manager (previous attendee), course was still better than expected”

“I particularly appreciated the quizzes and case histories”

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