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

Integrating In Vitro and In Vivo Toxicity Data with Computational Modeling to Achieve 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. […]

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Drug Development and Clinical Pharmacology Strategy

Changing the Game in Drug Development through a Strategic and Programmatic Approach Far too many cases treat drug development like a relay race, with the baton handed from one participant to the next. But, this approach risks missing opportunities to develop medicines faster and better. And lacking a holistic and strategic roadmap to achieve milestones […]

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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

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 […]

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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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Prediction of Clearance

Predicting Drug Clearance Using the Simcyp Simulator The Simcyp® Simulator predicts in vivo drug clearance from in vitro data, for the average individual and across populations. It also measures variability in clearance as a function of: Proportional metabolism by each enzyme Genetic/environmental variations in enzyme abundance Ethnic differences in genotype frequencies and levels of CYP and UGT […]

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Drug Metabolism

Assessing Drug Metabolism Using the Simcyp Simulator The Simcyp® Simulator extrapolates in vivo metabolic clearance from routine in vitro data generated during drug development using a variety of systems, including human liver microsomes (HLM), human intestinal microsomes (HIM), human hepatocytes (HHEP), recombinant cytochrome P450 and UGT enzymes (rCYP, rUGT), and cytosolic or S9 tissue fractions. […]

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