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

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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Clinical Pharmacology Gap Analysis

Increase your Odds of Regulatory Success with a Quantitative and Regulatory Science-based Strategy As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in performing a strategic assessment is a gap analysis and […]

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Quantitative Solutions

QuantitativeSolutions.net has moved to Certara.com Certara has acquired Quantitative Solutions, a global pharmacometrics consulting company headquartered in Menlo Park, California. This merger further strengthens Certara’s position in the burgeoning modeling and simulation/pharmacometric services field, broadening its modeling capabilities, deepening its therapeutic areas of expertise and adding new value-added services and clinical outcomes databases. The resulting organization is called Certara Strategic […]

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Model-based Meta-analysis

An Innovative Strategy to Make Better Use of Available Data The difference between getting a new medication to patients, and it ending up in the scrap heap of failed programs lies in making the right choices. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How […]

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Pharmacometrics

Crossing the Chasm: Pharmacometrics is a “Must Do” for a Successful Drug Program Successful drug development and commercialization requires getting critical decisions right—what is the exposure-response relationship for the drug, what is the optimal dosing strategy, and which patients would derive greatest benefit from it. Pharmacometrics uses mathematical and statistical models to quantify drug, disease, […]

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PK/PD Drug and Disease Modeling and Simulation

Quantifying Drug, Disease, and Trial Information to Aid Efficient Drug Development For almost 20 years, our pharmacometricians have combined insight and innovation to build quantitative models of the interactions between the human body, drug effects, and diseases. Our team develops models that are fit-for-purpose and meet strategic objectives, are aligned with regulatory authority requirements and […]

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About Our Consulting Services

Why Partner with our Drug Development, Regulatory, and Clinical Pharmacology Experts? Committed to scientific, regulatory, and commercial advancement, Certara creates impactful solutions facing the biopharm industry today—speed and cost. The largest and most comprehensive provider of strategic drug development, modeling and simulation, and regulatory science services, Certara partners with you to optimize drug development and […]

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