Using Virtual Twin™ Technology to Predict Drug Exposure in Individual Patients

Thomas Polasek

Physiologically-based pharmacokinetics (PBPK) is a valuable resource to support decisions throughout drug development for sponsors and regulators. PBPK is used extensively to predict drug-drug interactions (DDIs), to inform dosing and clinical study design, to predict drug exposure, to predict variation in drug clearance, and to understand mechanisms of drug disposition. Virtual Twin technology, based on […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

Using Virtual Twin™ Technology for Model-informed Precision Dosing

Thomas Polasek

In a recent Expert Review of Clinical Pharmacology article, I assessed the status and future direction of precision dosing in clinical medicine.1 Model-informed precision dosing (MIPD) is a modeling and simulation (M&S) approach in healthcare that is used to predict the most effective and/or least toxic drug dose for a patient. MIPD could revolutionize healthcare […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

Using M&S to Evaluate Oncology Drug Dosing

Maria Saluta

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions

Maria Saluta

Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and regulators also need to determine how to best utilize and report modeling and simulation results […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Regulatory Submissions Management

Training Your Way

E-learning Courses: Training at Your Convenience Certara University has expanded its educational reach via the introduction of an e-learning platform. E-learning classes are now available in various topics such as Introduction to Phoenix Winnonlin, Population Modeling Using Phoenix NLME, Fundamentals of Pharmacokinetics, Non-compartmental Data Analysis, Introduction to Statistics with R, and many other courses. See […]

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Pharmacology to Payer

Focus on Patient Centricity In traditional drug development, limited engagement—or engagement too late in the development program—between sponsors, regulators, and payers can result in unacceptable delays of patient access to life-saving medicines. While alternative approaches such as Adaptive Licensing, which includes staggered approval, managed entry, and progressive authorization have expedited the process, it addresses only […]

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Quantitative Systems Toxicology and Safety

A Pathway-based Approach to More Efficient Chemical Risk Assessment A major challenge in developing efficacious and safe drugs is the ability to understand and effectively predict adverse effects of xenobiotic substances on extremely complex biological systems early in the drug discovery process. An alarming fact is that thirty percent of adverse drug reactions (ADRs) cannot […]

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Drug Development and Clinical Pharmacology Strategy

Strategic Drug Development Involves Thinking Without Borders™ Certara has demonstrated that a modern, state-of-the-art integrated drug development approach, using quantitative methods to inform, guide, and supplant traditional development methods, will dramatically improve efficiency and reduce costs. Creating unquestionable value for our clients is our objective. To achieve these objectives, Certara employs a strategic and programmatic […]

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Trainers

Meet the Certara University Trainers Nathan Teuscher is a leader in the pharmaceutical industry as a scientist, consultant, and teacher. Nathan has been teaching and training for over 15 years in the pharmaceutical industry, providing lectures in general pharmacokinetics to non-scientists, and specialized training in population pharmacokinetics and drug development to industry experts. Nathan also […]

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Training Your Way

Classroom Courses: Training in Group Settings Certara’s classroom trainings are offered by our scientific experts and leadership in variety of topics including: Population Modeling Methodology IVIVC Toolkit for Phoenix WinNonlin—In Vivo-In Vitro Correlations Intermediate PK/PD Modeling Methodology Variety of Simcyp Workshops Classroom trainings are offered around the globe and course schedules are posted on the Certara […]

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On-site Training

On-site Training: We’ll Come to You Certara University trainers deliver PK/PD modeling and simulation courses at your site! Certara’s on-site training is one of the most cost-effective ways to facilitate your organization’s learning and development goals. Choose from our standard curriculum or customize training to fit your organization’s needs with an expert on-site. We will […]

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Clinical Outcomes Databases for Specific Therapeutic Areas

About our Clinical Trial Outcomes Databases Our Clinical Trial Outcomes Databases form a quantitative framework to leverage valuable external data, providing key development insights to maximize the probability of success for a new drug. Comparative effectiveness Endpoint and subpopulation relationships Biomarker efficacy and safety outcome Trial design optimization Competitive analysis and commercial viability Gathering, formatting, […]

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Quantitative Systems Pharmacology

QSP: Integrating Quantitative Drug Data with Knowledge of Its Mechanism of Action One of the biggest challenges—and, hence, the biggest opportunity for QSP—is drug attrition in Phase 2 clinical trials. Investigational medicines are usually tested for the first time in patients in Phase 2 clinical trials. This is the point when many drug programs fail. […]

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Certara University

The Importance of Modeling & Simulation Education Certara University is dedicated to shaping the future of healthcare innovation through modeling and simulation education. Certara University provides modeling and simulation education, skills, and expertise in the global healthcare industry. We recognize that continuing education in both the theory and practice of modeling and simulation in drug […]

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Simcyp Workshops FAQ

Learn More About Our Simcyp Workshops What are the benefits of the Simcyp week-long workshops? Participants will learn about the application of “prior knowledge” to improve the selection and design of clinical studies. The workshops are designed to provide the necessary understanding and skills to simulate and predict the pharmacokinetics of drugs in any relevant […]

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Simcyp Workshops

About Our Workshops Learn About The Simcyp Workshops The model-based approach to various aspects of drug development is rapidly being adopted by many of the leading pharmaceutical companies and has been identified by the FDA as a valuable tool to improve efficiency in drug development. These workshops focus on the optimal use of compound-specific in […]

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Prediction of Drug-drug Interactions

Predicting Drug-drug Interactions Using the Simcyp Simulator Unmanageable drug-drug interactions have led to the withdrawal of numerous drugs from the market. Many of these interactions involve inhibition and, to a lesser extent, induction of drug metabolizing enzymes. Consequently, the ability to predict metabolically-based drug-drug interactions (mDDI) early in the drug development process is essential. The sophisticated […]

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