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

Clinical Pharmacology Gap Analysis: Your FAQs

Julie Bullock

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 that performing that strategic assessment is a gap analysis and roadmap. Over the last couple of months, I’ve written a series of blog […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Clinical Pharmacology Gap Analysis: Lessons Learned

Julie Bullock

Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs. While gap analysis can be performed at any point in the drug development continuum, early engagement is best for maximizing its benefits. […]

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

Beam Me Up, Scotty! Probing the Mechanisms of Transporter-mediated Drug Disposition

Matthew Harwood

Over the last 15 years, the importance of drug transporters has become paramount for understanding drug absorption, distribution into tissues, and in particular, drug-drug interactions (DDIs). In vitro-in vivo extrapolation (IVIVE) is an approach to link in vitro systems to the human in vivo situation using algorithms and physiologically-based scaling factors. In this blog, I […]

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Topics: PBPK Modeling & Simulation

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

Certara’s Best of the Blog 2017

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

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Changing the Game in Drug Development

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 unlock millions of dollars in R&D savings.

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