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

Pharmacometrics Skills Competition MIDD Gran Prix

Julie Dumond

Sitting around the Certara’s Raleigh office conference room, sketching out a pitch for a pharmacometrics contest at a national meeting, none of us were overly confident in its viability. Mark Lovern had been talking about the importance of communication skills for pharmacometricians. For them to influence critical drug development decisions, they should be able to […]

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Topics: PK/PD Modeling & Simulation

About Certara

Changing the Game in Drug Development and Patient Access At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and […]

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FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Ellen Leinfuss

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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

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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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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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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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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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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Therapeutic Areas

Therapeutic Areas of Expertise: Strategic Drug Development Services Certara’s global consulting team has unparalleled experience across all development phases and in all major therapeutic areas. We have collaborated with sponsors, both large and small, to provide insight into key decisions, including dosing and toxicity, efficacy and biological impact, comparative effectiveness, clinical trial design, regulatory strategy, and […]

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Orphan Drug Development

Orphan Drugs: Unique Challenges Require Unique Development Approaches Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patient populations are difficult to identify and recruit for clinical trials. Many orphan diseases are genetic. Often these patients have complex phenotypes that react very differently to proposed treatment […]

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Pediatric Drug Development

Understanding Drug Effects in Children Pediatric drug development continues to be a vexing challenge, yet pediatric research is increasingly being mandated by regulators and patients alike. Traditional development methods can be problematic for ethical and logistical reasons. Children are a heterogeneous population, especially neonates and infants, as organ maturation affects drug exposure and response. Leveraging […]

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Label Optimization

Drug Label Optimization Using Proven Modeling and Simulation Methodology The drug label is the culmination of years of work and millions, if not billions of dollars. Every inclusion and exclusion on that label will have a direct impact on the drug’s profitability. While modeling and simulation have been an important element in drug development for some time, […]

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Benefits of Modeling and Simulation

The Benefits of Modeling and Simulation in Drug Development Modeling and simulation, also known as “model-informed drug development,” has already had a profound impact on drug development, yet its full impact is just now coming to light.  Modeling and simulation (M&S) has the proven ability to influence every phase of the drug development process, including […]

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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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