Quantitative Drug Development – Certara

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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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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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d3 Medicine

Developing Medicines that Matter

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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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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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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 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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