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Cost - $1,000 (Academia $500, India $250) Course Description This course is designed to explore advanced techniques in pharmacokinetic and pharmacodynamics modelling and simulation that are directly applicable to current challenges in drug development. In depth theory is coupled with examples from current literature to provide a complete training experience. Topics include complicated population pharmacokinetic models, PK/PD modelling of oncology studies, modelling transit compartments, target mediated drug disposition, and extrapolation from adults to children. If you are an academic user, please contact us so we can update your account profile to give you access to academic pricing.  Note that you must register with an email address that is associated with an academic institution to get academic pricing. If you are located in India, please contact us so we can provide a coupon that will give 75% off the full price of the course.  You will need to provide proof that you are physically located in India to get the coupon. Software Used Phoenix NLME™ A temporary (30-day) license is provided to subscribers of this course.  When you are ready to start the practice exercises in this course, contact us to request your license. Accessing the Course After registering for this course, login to www.certarauniversity.com and you will see the course on your Dashboard. You will have access to this course for a period of 3 years after the purchase. The purchase is for a single seat in the course. No sharing the login between different individuals is allowed. Additional seats must be purchased if more than one person wishes to take the training course. Course Length:  The course provides approximately 3 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 12+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites Before attending this course, attendees should be familiar with creating models using PML (Phoenix Modeling Language). Participants should also be able to perform the tasks in the following Certara University courses: Introduction to Population Modeling using Phoenix NLME (On-Demand 101-OD) Intermediate Population Modeling using Phoenix NLME (On-Demand 201-OD) Instructor Carlos Rodríguez, Ph.D. Director, Clinical Pharmacology and PK/PD, PharmaPolaris International, Inc. Carlos Rodríguez has over 25 years of experience in the pharmaceutical industry in the areas of Clinical and Preclinical Pharmacokinetics, Drug Metabolism, Clinical Pharmacology, and Pharmacometrics. Dr. Rodríguez obtained a B.S. in Pharmacy from the University of Puerto Rico in 1986, and Ph.D. in Pharmaceutics from The University of Michigan in 1991. He joined The Upjohn Company in 1991 as a Scientist supporting preclinical pharmacokinetics and bioanalysis in the areas of CNS, metabolic diseases, cardiovascular, and anti-infectives. In 1997 he joined the clinical pharmacology unit (then Pharmacia & Upjohn), where he supported development projects in CNS and infectious diseases. In 2001, he became Associate Director of Pharmacokinetics at Chiron Corporation, where he supported small and large molecule programs in anti-infectives, oncology, and organ transplantation. In 2005, he became Director of Clinical Pharmacology at Roche Palo Alto, where he had direct responsibility over the clinical pharmacology development aspects of compounds in the anti-infective and inflammation therapeutic areas, including small and large molecules. He joined PharmaPolaris in 2007. Dr. Rodríguez has been involved in numerous IND submissions and participated in at least 10 NDA filings. In addition to Clinical Pharmacology, his research interests include Renal Drug Transport, Pharmacostatistical Modeling, Clinical Trial Simulation, and Population PK/PD. Dr. Rodríguez serves in the faculty of The University of Michigan, where he is Adjunct Associate Professor of Pharmaceutical Sciences, and in the faculty of the University of the Pacific, where he is Adjunct Professor of Pharmaceutics and Medicinal Chemistry. He lectures at the undergraduate and graduate levels in the areas of Pharmacokinetics, Physical Pharmacy, and Pharmacometrics. Read More

Cost - Free Several easy-to-use templates, that require minimum user input, have been developed to address a series of BE regulatory guidances.  In this course, we discuss the purpose of each Phoenix workflow template,  show you how to download templates, and teach you and how to use them. Current Available Phoenix Workflow Templates: Assessing Reference Scaled Average Bioequivalence (RSABE) for Highly Variable Drugs (HVD) - FDA + EMA Assessing Reference Scaled Average Bioequivalence (RSABE) for Narrow Therapeutic Index Drugs (NTID) - FDA Assessing Bioequivalence to Methylphenidate Hydrochloride (Concerta) - FDA   Read More

Cost - Free PML-School: Learn How to Build Custom PK and PK/PD Models in Phoenix WinNonlin In this series of videos you will learn how to create models using Phoenix Modeling Language (PML).  These are the recordings of the PML school webinars which can also be found on the Phoenix Support Forum. Read More

Cost - Free This course will teach you the new features, functionality and improvements available in Phoenix WinNonlin 8.3 (released June 2020). The course explains the new features that have been added in Phoenix version 8.3.  Complimentary videos explaining enhancements in previous versions are also available at Certara University. This course is intended for users upgrading to Phoenix WinNonlin version 8.3 who have prior experience with Phoenix version 8.2. There is no need to have the software installed to take this course. Software Used Phoenix WinNonlin 8.3.  You can download Phoenix 8.3 here. Accessing the Course After registering for this course, login to www.certarauniversity.com and start/resume the course on your Dashboard. Course Length:  The course provides approximately 2 hours of video instruction that you can do at your own pace.  Prerequisites Participants should have a good background in pharmacokinetics, and prior experience with Phoenix WinNonlin 8.2. Read More

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