On behalf of PSI  (Statisticians in the Pharmaceutical Industry) I am pleased 
to announce the following training course : 

 

Introductory workshop on Optimum Design Theory and its application to 
Pharmaceutical Drug Development, presented by Patrick Johnson (JPharma 
Solutions), Gordon Graham (Novartis) , and Barbara Bogacka (Queen Mary, 
University of London).

 

The course will run on 6-7th November 2013 at the Park Inn Hotel, Bath Road, 
Heathrow UB7 0DU.

 

Course outline: 

Pre-clinical and clinical studies are performed in drug development with one of 
the main objectives being the description of observed data through the use of 
regression models.  When designing these studies it is desirable that the 
collected data will be informative for these model fitting purposes.  This 
course will look at the application of experimental design optimality criteria 
for selecting design variables in the context of fitting a range of regression 
models.  Example models include:

 

·         Linear regression models

·         Nonlinear models:  sampling time selection for pharmacokinetic models 
and dose selection for dose-response models

·         Nonlinear mixed effect models: blood sampling time selection for 
population pharmacokinetic models

 

This two day course provides an introduction to optimum design theory and its 
application for the efficient design of studies for the purposes of regression 
modelling. The emphasis will be to deliver a course that mixes theory and 
practical examples explored in hands-on workshops.  

 


Theory 

Provide an overview of optimum design theory for the purpose of regression 
modelling, including linear and nonlinear models and mixed effects models.


Application 

Discuss application of optimum design theory in drug development, in particular 
dose-response and pharmacokinetic models, illustrated with simulated examples 
and real examples taken from the literature.


Software Tools 

The course will use R and PFIM, a program written for R that evaluates and 
optimises designs for nonlinear mixed effects models


Workshops 

To reinforce the optimum design theory, hands-on examples will be explored in 
workshops. The workshops will introduce a range of modelling and design 
problems, which the delegates will explore through hands-on tasks. Examples 
will start with simple models such as linear models, building to complex models 
such as nonlinear mixed effect models.

 

The workshop is targeted at statisticians and pharmacometricians who are 
involved in selecting the key design variables such as doses, sampling times 
and sample size in pre-clinical and clinical studies for the purposes of 
regression modelling.

 

To book a place, go to the PSI website.

 


Please register online at  <http://www.psiweb.org/> www.psiweb.org  (click on 
Events); payment is now available online.

Registration costs (includes lunch and refreshments):


Early-Bird Registration on or before 

01 October 2013

PSI Members: £495 plus vat 

Non-members: £530 plus vat

Registration after 

01 October 2013 

PSI Members: £595 plus vat 

Non-members: £630 plus vat 

 

 

PSI reserves the right to cancel the course if an insufficient number of 
delegates is registered by the early-bird deadline, in which case the course 
fees and any hotel booking costs made through PSI will be refunded.

 

For further information please contact: 

Emma Lovett, Tel: +44 (0)845 180 349, Fax: +44 (0)1730 715291, Email: 
[email protected]

 

 

Gemma Hodgson

Qi Statistics Ltd

 

http://www.qistatistics.co.uk <http://www.qistatistics.co.uk/> 

 

Direct Dial: +44 (0)1732 848606

Mobile:      +44 (0)7708 700503

 

Trading Address:  Penhales House, Ruscombe Lane, Ruscombe, Reading RG10 9JN

VAT Registration: 527 2571 45

Company registration:  4203486

Registered Address:  Overdene House, 49 Church Street, Theale, Berkshire RG7 5BX

 

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IMPORTANT: This communication is to be treated as confidential and the 
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