Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
Apocalyptic clinical pharmacology helps drug developers save resources and time through providing a framework for understanding the interaction of the drug under development with the biological system. This framework also helps answer questions from regulatory authorities who are evaluating the safety and efficacy of the drug. Making informed decisions throughout the drug development process requires […]
Read MoreWatch this webinar with Nikunjkumar Patel, Shriram Pathak, and Rachel Rose to learn how the latest updates in the Simcyp Simulator v18 will help support developing safer, more effective medications.
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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 […]
Read MorePRINCETON, NJ – Nov. 14, 2018 – Certara today announced that it has been awarded two new dermal virtual bioequivalence grants by the US Food and Drug Administration (FDA).
Read MorePRINCETON, NJ – Oct. 9, 2018 – Certara today announced that the US Food and Drug Administration (FDA) has renewed, and in many cases increased, its number of Certara software licenses for reviewing new drug and biologics applications.
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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 […]
Read MoreBiologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.
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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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