How do we use prior study information to improve the next study? Optimal Design
does exactly this. We can predict better sampling times, better dose levels to
use, the number of groups and subjects to use to achieve needed power, and more.
Three of the world's top experts in Optimal Design for Pharmacometrics (Stephen
Duffull, Andrew Hooker, and France Mentré) have teamed up and created a
four-day course on the topic. The course has been rescheduled, and so the first
public offering will now be March 10-13, 2014 in Cary, NC. Each day 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, groups,
etc.)
- Multiple response models - turnover models and others in PKPD
- Maximizing the probability of experimental success, the ability to
discriminate 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 designs
using prior study information. Seating is limited.
Course dates: March 10 - 13, 2014, in Cary, NC
Course information and registration:
http://www.pharsight.com/training/course_display_new.php?details_id=116
Advertisement for course:
ftp://ftp_training:[email protected]/training/OD-Sept30-Oct3.pdf
Course outline:
ftp://ftp_training:[email protected]/training/OD-Outline.pdf
Biographies of the instructors:
Stephen Duffull is Professor of Clinical Pharmacy and the Dean of the School of
Pharmacy at the University of Otago, Dunedin, New Zealand. He runs a modelling
and simulation lab within the School of Pharmacy. Research interests include
optimal design, MCMC methods particularly in clinical toxicology and
haemostasis. He has been involved in the area of PKPD and nonlinear mixed
effects modelling for 20 years. Stephen is the primary developer of WinPOPT and
POPT.
Andrew Hooker is an Associate Professor of Pharmacometrics at Uppsala
University, Sweden. Andrew received a PhD and MSc in Bioengineering from the
University of Washington and a BS in Physics (Minor in Mathematics) from the
University of Colorado. His research interests range between methodological
and applied pharmacometrics including: optimal experimental design,
methodological problems associated with building and evaluating pharmacometric
models, (repeated) time-to-event model building and the development and use of
PKPD models in drug development. Therapeutic areas of interest for Andrew
include cancer, addiction, PET, biologics, etc. Andrew is a primary developer
of the software programs Xpose 4, PsN and the optimal design program PopED.
France Mentré is Professor of Biostatistics at the University Paris Diderot
(Paris 7), France. She heads an INSERM research team on Biostatistical
Modelling and Pharmacometrics. She has worked on development and application
of methods for nonlinear mixed-effects models in pharmacokinetics and
pharmacodynamics for more than 20 years. Her main research areas in this field
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
Certara(tm)
Implementing Translational Science
100 Mathilda Place, Suite 160, Sunnyvale, CA 94086
Email [email protected]<mailto:[email protected]>
Certara: The name behind the names you know
Tripos - Simcyp - Pharsight
http://www.certara.com/