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The Experts Teach Optimal Design for Pharmacometrics: March 10-13, 2014 (new dates)

From: Helen Moore <Helen.Moore>
Date: Mon, 21 Oct 2013 12:22:11 -0400

How do we use prior study information to improve the next study? Optimal De=
sign does exactly this. We can predict better sampling times, better dose l=
evels to use, the number of groups and subjects to use to achieve needed po=
wer, and more.

Three of the world's top experts in Optimal Design for Pharmacometrics (Ste=
phen Duffull, Andrew Hooker, and France Mentré) have teamed up and create=
d a four-day course on the topic. The course has been rescheduled, and so t=
he first public offering will now be March 10-13, 2014 in Cary, NC. Each da=
y includes small group discussion sessions/consultations to help attendees =
learn how to implement these techniques in their own studies. An entire day=
 is devoted to hands-on examples using PFIMOpt software.

Topics Include:

- Introduction to the study design

- Introduction to the Fisher Information Matrix (FIM)

- FIM for nonlinear models and nonlinear mixed effects models

- Design optimization

- D-optimality, C-optimality, etc. and their interpretations

- Accounting for uncertainty in beliefs about the parameter and model space

- Design constraints in optimization (number of samples, time ranges, group=
s, etc.)

- Multiple response models - turnover models and others in PKPD

- Maximizing the probability of experimental success, the ability to discri=
minate between models

- An introduction to adaptive design

- Handling data below the limit of quantitation

- Study power and optimal design

Sign up and learn how to improve your preclinical and clinical study design=
s using prior study information. Seating is limited.

Course dates: March 10 - 13, 2014, in Cary, NC

Course information and registration: (Corr=

Advertisement for course (dates will actually be March 10-13, 2014): ftp://=

Course outline (dates will actually be March 10-13, 2014): ftp://ftp_train=

Biographies of the instructors:

Stephen Duffull is Professor of Clinical Pharmacy and the Dean of the Schoo=
l of Pharmacy at the University of Otago, Dunedin, New Zealand. He runs a m=
odelling and simulation lab within the School of Pharmacy. Research interes=
ts include optimal design, MCMC methods particularly in clinical toxicology=
 and haemostasis. He has been involved in the area of PKPD and nonlinear mi=
xed effects modelling for 20 years. Stephen is the primary developer of Win=

Andrew Hooker is an Associate Professor of Pharmacometrics at Uppsala Unive=
rsity, Sweden. Andrew received a PhD and MSc in Bioengineering from the Un=
iversity of Washington and a BS in Physics (Minor in Mathematics) from the =
University of Colorado. His research interests range between methodologica=
l and applied pharmacometrics including: optimal experimental design, metho=
dological problems associated with building and evaluating pharmacometric m=
odels, (repeated) time-to-event model building and the development and use =
of PKPD models in drug development. Therapeutic areas of interest for Andr=
ew include cancer, addiction, PET, biologics, etc. Andrew is a primary deve=
loper of the software programs Xpose 4, PsN and the optimal design program =

France Mentré is Professor of Biostatistics at the University Paris Dider=
ot (Paris 7), France. She heads an INSERM research team on Biostatistical =
Modelling and Pharmacometrics. She has worked on development and applicati=
on of methods for nonlinear mixed-effects models in pharmacokinetics and ph=
armacodynamics for more than 20 years. Her main research areas in this fiel=
d are optimal design, model evaluation and anti-infective agents. France is=
 the primary developer for PFIM and PFIM Interface.

This course is hosted by Pharsight, A Certara Company.

Helen Moore, PhD
Senior Scientific Consultant
Implementing Translational Science
100 Mathilda Place, Suite 160, Sunnyvale, CA 94086
Email Helen.Moore

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Received on Mon Oct 21 2013 - 12:22:11 EDT

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