Cost - $500 (Academia $250, Africa/India $125) Course Description This training will utilize hands-on examples to instruct attendees in the use of the IVIVC Toolkit for Phoenix WinNonlin, which expands the capabilities of Phoenix WinNonlin to include in vivo-in vitro correlations (IVIVC) analysis. The Toolkit contains advanced tools for deconvolution methods, numerical convolution, new plotting capability, and the IVIVC Wizard. 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 Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing. You will need to provide proof that you are physically located in India to get the pricing. Software Used Phoenix IVIVC™ 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, access 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 4.5 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 18+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites Basic knowledge of Phoenix WinNonlin is recommended, particularly in conducting NCA analyses. It is also useful for learners to have some PK modeling experience. We recommend that participants know how to perform the tasks in the following Certara University course: Phoenix WinNonlin (Part 1) NCA Certification Course | e-Learning (122-OD-CERT) Instructor Simon Davis has been supporting and training scientists in the pharmaceutical industry to configure and use PKPD modelling tools effectively. Initially working in Covance’s Phase I clinic analysing BE, FIM studies etc. using WinNonlin & SAS, he spent several years providing Support and Training for Watson, EP and Kinetica software whilst at InnaPhase, (now ThermoFisher). Since 2005 he has focused on the Phoenix platform modules of WinNonlin, IVIVC, Connect, PKS & NLME. As well as providing hands on training to users he also gives development direction to ensure this suite of tools meet the needs of our diverse users; from simple NCA and IVIVC under GxP, to advanced modelers and connect with other industry databases and analytical tools e.g. R & NONMEM. Read more
Cost - $299 (Academia $150, Africa/India $75) - [Conceptual Course] Course Description This course teaches the basic principles of pharmacokinetics including absorption, distribution, metabolism, and excretion. The lessons are taught by a vibrant instructor who uses real-world examples to explain the key concepts. This course will provide the student confidence to discuss basic pharmacokinetic concepts. 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 Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing. You will need to provide proof that you are physically located in India to get the pricing. Software Used None 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 1.5 hours of video instruction and quizzes that you can do at your own pace. It is expected to take participants about 3+ hours to complete. Prerequisites None Instructor Ana Henry 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.span> Read more
Cost - $299 (Academia $150, Africa/India $75) - [Conceptual Course] Course Description This course is a comprehensive overview of noncompartmental analysis of pharmacokinetic data. This course will cover the basics through the most complex areas of noncompartmental analysis. The course includes video presentations, spreadsheet-based problems, and guided answers. Anyone with interest in pharmacokinetics, drug disposition, drug metabolism should take this course. In addition, this course is an excellent primer for pharmacists, physicians, and other healthcare professions that work with pharmaceutical agents. In addition, clinical trial managers and clinical research associates would benefit from this 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 on a permanent basis in Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing. You will need to provide proof that you are physically located in India to get the pricing. Software Used Using a spreadsheet (such as Microsoft Excel™) is recommended for doing the calculations. This course teaches NCA concepts and doesn't include the use of Phoenix WinNonlin. To learn how to use Phoenix WinNonlin to do NCA, see courses (122-LO) or (100-OD). Accessing the Course After registering for this course, login to certarauniversity.com and access 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 2 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 4 hours to complete, including time to perform the tasks in a spreadsheet program. Prerequisites None Instructor Tom Jones Tom Jones has helped thousands of scientists become proficient with using Certara software in their research in the pharmaceutical industry. After completing his Ph.D. in analytical chemistry, he spent several years as an assistant professor, during which time he applied molecular modeling to teaching and research in chemistry, and then came to Certara, where for 18 years he has applied his passion for teaching scientific software applications. At first Tom was focused exclusively on molecular modeling applications in drug discovery and later broadened his expertise to include informatics and PK/PD modeling and analysis. He has created many training manuals, and you may very well have heard his voice in one of the numerous webinars and video demos he has created to help scientists become more proficient with Certara software. Read more
Complimentary Phoenix Templates for Bioequivalence. Several easy-to-use Phoenix 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. Course Content: Module 1: Template Downloads Module 2: Assessing Reference Scaled Average Bioequivalence (RSABE) for Highly Variable Drugs (HVD) - FDA + EMA Module 3: Assessing Reference Scaled Average Bioequivalence (RSABE) for Narrow Therapeutic Index Drugs (NTID) - FDA Module 4: Assessing Bioequivalence to Methylphenidate Hydrochloride (Concerta) - FDA Module 5: Assessing ABE and PBE for In Vitro Data of Inhaled Products (Guidance on Budesonide) - 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
Course Registration: $550 (Academic Discounts Available) If you are an academic user, please contact us for available discounts. Course Description: Embark on a captivating journey into the realm of pharmacokinetics. This on-demand course will introduce you to the intricate science of pharmacokinetics and its practical applications in clinical settings, where understanding drug kinetics isn't just academic—it's the cornerstone of effective patient care. Developed as a conceptual course, this immersive learning experience, led by esteemed instructor Dr. Stephan Schmidt, UF-Certara Professor, offers a dynamic exploration of drug kinetics tailored to your learning pace and preferences. This course is designed to introduce you to drug kinetics and their practical applications in clinical practice. Throughout the course, participants will engage in hands-on exercises, case studies, quizzes, and simulations to reinforce theoretical concepts and enhance practical skills. By the end of the program, participants will gain proficiency in applying pharmacokinetic principles to optimize drug dosing regimens and improve therapeutic outcomes in clinical settings. You will benefit from Dr. Stephan Schmidt's expertise and guidance as he navigates you through complex pharmacokinetic principles and real-world applications. Course Structure: Duration: Accessible for one year post-registration, providing ample time for comprehensive learning and review. Certificate of Completion: Earn a prestigious certificate by achieving a minimum grade of 80% on all quizzes, designed for unlimited attempts to ensure mastery. Sequential Learning: Modules are meticulously sequenced, guiding learners through a logical progression of topics for enhanced comprehension. Interactive Quizzes: Embedded quizzes offer opportunities for self-assessment, ensuring understanding before advancing to subsequent modules. Practical Assignments: Engage with hands-on assignments integrated within modules, complete with detailed instructions and downloadable solution links. No Downloadable Materials: To prioritize active engagement, recordings and lecture slides are unavailable for download, fostering focused learning. Software Used None Accessing the Course After registering for this course, login to https://www.certarauniversity.com/learner-dashboard to start the course You will have access to this course for a period of 1 year 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 6 hours of video instruction, quizzes, and practice exercises that you can do at your own pace. In addition, It is expected to take participants about 40+ hours to complete. Prerequisites None Instructor Stephan Schmidt, B.Pharm., Ph.D., F.C.P. Stephan Schmidt is an endowed Professor in the Department of Pharmaceutics at the University of Florida, where he also serves as the Director for the Center for Pharmacometrics and Systems Pharmacology. He received his B.S. in Pharmacy from the Friedrich-Alexander University in Erlangen, Germany, and his PhD in Pharmacy from the University of Florida in Gainesville, USA. Following a post-doctoral fellowship at the Leiden-Amsterdam Center for Drug Research, he rejoined the University of Florida as faculty in 2012. Dr. Schmidt’s research focuses on the development and application of mechanism/physiologically-based drug-disease trial models to address clinically relevant questions in the area of antimicrobial chemotherapy, chronic progressive diseases, special patient populations, and drug-drug interactions. He published more than 150 peer-reviewed scientific manuscripts, 8 book chapters, and 2 textbooks, including the fifth edition of Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics textbook, one of the world-wide leading textbooks in the quantitative clinical pharmacology arena. He received numerous awards including the University of Florida Excellence Award for Assistant Professors in 2013, the Tanabe Young Investigator Award from the American College of Clinical Pharmacology (ACCP) in 2016, the Outstanding Doctoral Thesis Mentoring Award from UF’s College of Pharmacy in 2018, the Excellence in Academia, MIDD+ Scientific Conference Award in 2021, and the University of Florida Research Foundation Professor Award in 2023. Dr. Schmidt serves as clinical pharmacology section editor of the European Journal of Pharmaceutical Sciences as well as editorial board member of the Journal of Clinical Pharmacology and the European Journal of Pharmaceutical Sciences, and Scientific Advisor to the Editors of the Journal of Pharmaceutical Sciences. Certificates: Participants who complete this course within 1 year will be provided with a Certificate of Completion from Certara University. Contact Us: For additional information, please contact us. Read more
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