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 first public offering is Sept 30-Oct 3, 2013, 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: September 30 - October 3, 2013, 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<http://xpose.sf.net/>, PsN <http://psn.sf.net/> and the optimal design program PopED<http://poped.sf.net/>. 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. Course is hosted by Pharsight, A CertaraTM 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 www.certara.com<http://www.certara.com/> NOTICE: The information contained in this electronic mail message is intended only for the personal and confidential use of the designated recipient(s) named above. This message may be an attorney-client communication, may be protected by the work product doctrine, and may be subject to a protective order. As such, this message is privileged and confidential. If the reader of this message is not the intended recipient or an agent responsible for delivering it to the intended recipient, you are hereby notified that you have received this message in error and that any review, dissemination, distribution, or copying of this message is strictly prohibited. If you have received this communication in error, please notify us immediately by telephone and e-mail and destroy any and all copies of this message in your possession (whether hard copies or electronically stored copies). Thank you. buSp9xeMeKEbrUze
