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 Mentr) 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: https://www.certara.com/training (Corrected)
Advertisement for course (dates will actually be March 10-13, 2014): ftp://ftp_training:NYXuZRBdfY9O
Course outline (dates will actually be March 10-13, 2014): ftp://ftp_training:NYXuZRBdfY9O
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 Mentr 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
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Email Helen.Moore
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