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Cost - $500 (Academia $250, India $125) Course Description The objective of this course is to train Phoenix WinNonlin users how to perform population PK using Phoenix NLME. Population PK/PD modeling is being used increasingly in regulatory submissions.  Population PK modeling can handle sparse data and also data combined from several studies.   The population approach estimates the variability between subjects in the PK parameters and can help you understand potential sources of PK variability. Through a series of practical exercises, learners will create population PK models, add covariates to models to help explain and quantify individual variation, and validate their models using bootstrap and VPC. Learners will become familiar with the theory necessary to make effective use of population modeling. 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. Course Format, Language and Dates This course format is as a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times.  This format provides the benefit of the classroom setting, with real-time interaction with the instructor but without the travel.  Although live attending is encouraged, recordings of the sessions are available to participants during the length of the course.  This course will be delivered in English. Although we have not finalized the dates for this course in 2022, you can enroll in this course now and we will hold a spot for you in one of our upcoming offerings.  When we set the dates for 2022, you can select which course you want to attend. Prerequisites and Time Commitment Fundamental knowledge of PK/PD concepts including basic compartmental models.  Familiarity with the functionality of Phoenix WinNonlin software.  Recommended background courses include: (103-OD) Fundamentals of Pharmacokinetics, and either (100-OD) Introduction to Phoenix WinNonlin or (123-LO) PK Modeling and Simulation using Phoenix WinNonlin. Students are expected to be able to commit 5 hrs a week to attend sessions and complete assignments. Software Phoenix NLME Participants are expected to have a current license to Phoenix NLME.  If a 60-day software license is needed one can be provided for an additional fee.  Contact us if you want to order a license. Certara Professional Certification [Optional] Participants may opt to pay a fee ($50) to obtain an additional professional certification as a Level 1 Pharmacometrician.  This certification requires passing an exam that this course will give you the sufficient knowledge to pass.  Contact us to add this certification to this course registration.  Click here for more details on Certara Professional Certifications.   Read More

Cost - $1000 (Academia $500, India $250) Course Description This course focuses on PK/PD individual data analysis using PK compartmental models and PK/PD models. The intermediate PK/PD course will teach you how to set the models in Phoenix WinNonlin and how to interpret the results. The course will guide you through the process of selecting the best model and how to make predictions with the final model. Model selection is performed selecting library models, building the model graphically or coding the model in PML language. Course topics include nonlinear modelling theory, fitting PK data, effect compartment PK/PD models, direct and indirect response PK/PD models, analyzing binary data, designing better studies and combining data among subjects. A high level overview of population methods is provided (Note that population methods are covered in detail in courses that use Phoenix NLME). The concepts of each topic are explained in detail via instructional videos. Exercises are introduced and you are expected to practice concepts learned by performing the exercises on your own. Step by step solution videos are also provided to check your work. Your understanding of the concepts discussed is tested via short quizzes throughout the course. 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 WinNonlin™  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 see the course under the Catalog Section ‘My Courses’.  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 16 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 40+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites It is assumed that learners have familiarity with NCA and individual PK/PD modeling, a good background in pharmacokinetics and pharmacodynamics, and prior experience with the Phoenix is recommended. Participants should also be able to perform the tasks in the following Certara University courses: Introduction to PK/PD Modeling using Phoenix WinNonlin (On-Demand 100-OD) Instructor Ana Henry has extensive experience in a variety of roles in the Pharmaceutical industry. Most recently she acted as product manager for the complete suite of Certara Pharsight desktop products, personally leading the development of Phoenix®, the industry’s premier PK/PD software platform. Currently, she is with Certara University’s Scientific Training and Education Department, tasked with training and content development of on-demand courses. Ana has extensive experience in software demonstration and training and is adept at offering technical expertise and evaluation of software products. She has trained and provided support for Phoenix WinNonlin, Phoenix Connect, Phoenix NLME, Pharsight Knowledgebase Suite, AutoPilot, PKS Reporter, Trial Simulator, and PK/PD methodology courses. Prior to Certara, Ana worked in the pharmaceutical industry as a biostatistician and a pharmacokineticist, designing, analyzing and reporting on clinical studies. Ana is also a regular guest speaker in the graduate PK/PD course at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. Read More

Cost - $1,000 (Academia $500, India $250) Course Description This course will help you fill the gaps to become a better Population Pharmacokinetic and Pharmacodynamic (PK/PD) modeler.  This e-learning course focuses on Population PK/PD modeling and simulation using the intuitive interface of Phoenix NLME.   This course topics include: population PK analysis with covariates, covariate search methods, complex PK models including multiple absorption processes and parent-metabolite models, Emax PK/PD models, an introduction to categorical response PD models, and modeling BLQ data in Phoenix NLME.  The concepts of each topic are explained in detail via instructional videos. Exercises are introduced and you are expected to practice concepts learned by performing the exercises on your own. Step by step solution videos are also provided to check your work. Your understanding of the concepts discussed is tested via short quizzes throughout the course. 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 10 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 40+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites It is assumed that learners have familiarity with individual PK/PD modeling as well as introductory level population PK/PD modeling experience. Participants should have a good background in pharmacokinetics and pharmacodynamics, and prior experience with the Phoenix is recommended. Participants should also be able to perform the tasks in both the following Certara University courses: Intermediate PK/PD Modeling using Phoenix WinNonlin (On-Demand 200-OD) Introduction to Population PK/PD Modeling using Phoenix NLME (On-Demand 101-OD) Instructor Christopher Mehl Christopher Mehl is a Senior Software Trainer with Certara University, and has been with Certara since 2003. His educational background is a BS in Molecular Biology from the Ohio State University, and an MS in Pharmacology from the University of Wisconsin. He has conducted over 200 training courses with Certara products such as Phoenix WinNonlin, IVIVC, NLME, PKS, and Trial Simulator. These include workshops at the US Food and Drug Administration, universities, customer sites, and courses open to the public. Read More

Cost - $500 (Academia $250, India $125) Course Description This course is intended for Phoenix users who want to extend beyond library models, to model their own data.  It provides a solid foundation and a structured approach to model building, to create your own PK and PK/PD models.  This highly practical course gives an accelerated introduction to customizing models with both the Graphical and Textual model editors in Phoenix.  It assumes that you have ideas for PK and/or PK/PD models that you want to construct, and you mainly need to know how to implement them in either the Graphical or Textual modes.  The course includes a basic introduction to PK/PD modeling and population PK modeling. There are about 3 hours of video in the course, plus interactive exercises.  You should expect to spend about 12 hours of work to finish.  You will have access to this course for a period of 3 years after purchase. 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. Prerequisites Learners who take either the e-learning course (100-OD) Introduction to Phoenix WinNonlin or the live online course (123-LO) PK Modeling and Simulation using Phoenix WinNonlin should have sufficient background to take this course.  Alternatively, learners should have knowledge/skills in the following areas: Knowledge of basic concepts of PK models Using Phoenix PK Library models (i.e., using the built-in options) Obtaining initial estimates for PK models (using NCA or other methods) Evaluating the fit of PK models Other Related Courses The following courses provide a deeper theoretical background, and provide a good complement to this course: (200-OD) Intermediate PK/PD Modeling using Phoenix WinNonlin (201-OD) Intermediate Population Modeling using Phoenix NLME Read More

Cost - $500 (Academia $250, India $125) Course Description The objective of this intermediate course is to consolidate knowledge of PK/PD concepts and advance to performing more complicated PK/PD modeling using Phoenix WinNonlin and Phoenix NLME.  You will learn how to customize your own models beyond library models, how to interpret and present your results, perform simulations, and how to deal with different types of covariates such as occasion covariates, and much more.  This course will also cover pharmacodynamic concepts and examples. Many case studies will be presented (please see agenda below).  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. Course Format, Language and Dates NEW: Starting in 2021, we offer 2 different office hours to provide Live support with this course around the globe. This course format is as a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times.  This format provides the benefit of the classroom setting, with real-time interaction with the instructor but without the travel.  Although live attending is encouraged, recordings of the sessions are available to participants during the length of the course.  This course will be delivered in English. The course runs from the 9 of November to the 14 of December,  2021. This course will start on 9 November 2021 and will run for 6 sessions every Tuesday from 10am to 12pm EST (New York).  There are two options for office hours to help with assignments: Option A: Fridays from 11am to 12pm EST (New York, GMT-5)  Option B: Fridays from 2pm to 3pm (Brisbane, Australia, GMT+10) Prerequisites and Time Commitment Good knowledge of PK/PD concepts including compartmental models for both individual and population.  Experience with the functionality of Phoenix WinNonlin and Phoenix NLME software.  Prerequisite background courses or similar experience include:  [(123-LO) PK Modeling and Simulation and (124) Introduction to Population Modeling] or [(100-OD) Introduction to Phoenix WinNonlin and (101-OD) Introduction to Population Modeling] Students are expected to be able to commit 5 hrs a week to attend sessions and complete assignments. Software Phoenix WinNonlin and Phoenix NLME Participants are expected to have a current license to Phoenix WinNonlin and Phoenix NLME.  If a 60-day software license is needed one can be provided for an additional fee.  Contact us if you want to order a license. Certara Professional Certification [Optional] Participants may opt to pay a fee ($50) to obtain an additional professional certification as a Level 1 Pharmacometrician.  This certification requires passing an exam that this course will give you the sufficient knowledge to pass.  Contact us to add this certification to this course registration.  Click here for more details on Certara Professional Certifications. Read More

Cost - $500 (Academia $250, India $125) Course Description The objective of this intermediate course is to consolidate knowledge of PK/PD concepts and advance to performing more complicated PK/PD modeling using Phoenix WinNonlin and Phoenix NLME.  You will learn how to customize your own models beyond library models, how to interpret and present your results, perform simulations, and how to deal with different types of covariates such as occasion covariates, and much more.  This course will also cover pharmacodynamic concepts and examples. Many case studies will be presented (please see agenda below).  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. Course Format, Language and Dates NEW: Starting in 2021, we offer 2 different office hours to provide Live support with this course around the globe. This course format is as a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times.  This format provides the benefit of the classroom setting, with real-time interaction with the instructor but without the travel.  Although live attending is encouraged, recordings of the sessions are available to participants during the length of the course.  This course will be delivered in English. We are working on the schedule for 2022.  You can enroll in this course now, and we will save a seat for you in a 207-LO course that we offer in 2022.  If we have more than one offering in 2022 you can choose which one you want to attend. Prerequisites and Time Commitment Good knowledge of PK/PD concepts including compartmental models for both individual and population.  Experience with the functionality of Phoenix WinNonlin and Phoenix NLME software.  Prerequisite background courses or similar experience include:  [(123-LO) PK Modeling and Simulation and (124) Introduction to Population Modeling] or [(100-OD) Introduction to Phoenix WinNonlin and (101-OD) Introduction to Population Modeling] Students are expected to be able to commit 5 hrs a week to attend sessions and complete assignments. Software Phoenix WinNonlin and Phoenix NLME Participants are expected to have a current license to Phoenix WinNonlin and Phoenix NLME.  If a 60-day software license is needed one can be provided for an additional fee.  Contact us if you want to order a license. Certara Professional Certification [Optional] Participants may opt to pay a fee ($50) to obtain an additional professional certification as a Level 1 Pharmacometrician.  This certification requires passing an exam that this course will give you the sufficient knowledge to pass.  Contact us to add this certification to this course registration.  Click here for more details on Certara Professional Certifications. Read More

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