A PSI Training Course on
Introduction to Pharmacokinetics and Bioequivalence
Simon Day (CTCT Limited)
Nelson Kinnersley (Roche Products Ltd)
4 – 5 February 2014
Denham Grove, Tilehouse Lane, Denham, nr Uxbridge,
Buckinghamshire UB9 5DU
This course serves as an introduction to pharmacokinetics and bioequivalence. It aims to introduce much of the terminology that is used. It will be most suited to Statisticians or Statistical Programmers who have familiarity with clinical trials but have had limited previous experience with designing or analysing trials with pharmacokinetics or bioequivalence objectives. A basic understanding of ANOVA will be assumed.
We will include many practical exercises to calculate pharmacokinetic parameters and discuss what they mean and why they are important. We will illustrate common study designs for single- and multiple-dose studies and accepted approaches to their analysis. Topics such as non-linear mixed effects models in population pharmacokinetics are beyond the scope of this introductory course and will not be covered.
The bioequivalence part of the course will discuss the accepted limits for bioequivalence and how these have developed historically. We will contrast individual bioequivalence and population bioequivalence and present some of the arguments for and against each approach. Study designs and sample size calculations will be covered. EU and FDA regulatory guidance documents will be described and other regulatory guidelines also highlighted.
The following key topics will be addressed:
Study objectives; MTD (Maximum Tolerated Dose) ADME – absorption, distribution, metabolism, excretion Single IV administration
Zero- and first-order elimination; elimination rate constant (k); volume of distribution (Vd); half-life (t1/2); clearance (CL); area under the plasma-concentration curve (AUC0–t, AUC0–∞) Oral administration
How drugs gets into the bloodstream; different types of oral formulations; rate of drug absorption; amount of drug in the body; plasma-concentration time curve; absorption rate constant (ka); bioavailability Multiple dose administration
Time to reach steady state; loading doses Bioequivalence
Introduction and basic principles
Average, individual and population bioequivalence
Analysis of simple 2-formulation experiments
75/75 rule, 80/20 rule, ±20 rule, 80/125 rule
Common study designs
FDA, CHMP and others.
Use of Computers:
A calculator will be useful for some of the worked examples. You may also like to bring your own laptop to work through other examples. SAS and R code will be available for you to practise those examples. If you do not have the option to bring a laptop then we hope to be able to pair you with another attendee but we cannot guarantee that option.
About the presenters:
Simon has spent most of his career in the pharmaceutical industry working in all phases of drug development and including five years heading the statistics unit at the UK regulatory authority (the Medicines and Healthcare products Regulatory Agency). He now runs his own consulting company, Clinical Trials Consulting & Training Limited.
Nelson has spent over 20 years in the pharmaceutical industry (CRO, Independent Consultant and Pharma) in a range of statistical, statistical programming and management roles. He has worked on many Phase 1 to IV trials across a range of therapeutic areas. While at Roche, he has focussed on early development clinical trials supporting Roche to reduce its Phase I cycle times while also helping to incorporate pharmacodynamic endpoints and biomarkers to assist earlier decision making.
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1 and
09:00 – 16:00 on Day 2.
Please register online at www.psiweb.org and click on Events; payment now available online.
Registration costs (includes lunch and refreshments)
Registration before 29 November 2013 PSI Members: £495 plus vat
Non-members: £540 plus vat
Registration on or after 29 November 2013
PSI Members: £595 plus vat
Non-members: £640 plus vat
Accommodation can’t be guaranteed after the early bird deadline
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)845 180349 or at PSI@mci-group.com for further information.
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