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Month: February 2015

Japanese Regulatory Agency Licenses Certara’s Phoenix and Simcyp Software

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Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s biosimulation software PRINCETON, NJ – Feb. 26, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s Phoenix® biosimulation solutions … Continued

Meet FDA Bioequivalence Criteria with WinNonlin RSABE Templates

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A study by the FDA Office of Generic Drugs (OGD) reviewed over 1000 bioequivalence (BE) studies of 180 drugs, of which over 30% were highly variable (HV). Because of this high variability, studies designed to show whether generic HV drugs are bioequivalent to their corresponding HV reference drugs may need to enroll large numbers of … Continued

Phoenix WinNonlin Validation Suite: Decrease the Time and Cost of Your Validation

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Do you or your company spend weeks or months manually performing the necessary steps for software validation? In this webinar, the Certara team discussed the requirements for computer system validation, how it’s performed, and how Certara’s validation products can significantly reduce the time, resources, and cost of the on-site validation of your Phoenix WinNonlin computer … Continued

Certara Donates Software to University of Maryland to Develop New Approaches to Drug Development

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Gift of Phoenix® software licenses, workshop assistance, and training renews the strong partnership established between the two organizations in 2012 PRINCETON, NJ – Feb. 19, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that it has donated Phoenix software and licenses to the University of Maryland School … Continued

Supporting Pharmacometrics Education at the University of Maryland

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Nelson Mandela is quoted with saying, “Education is the most powerful weapon which you can use to change the world.” At Certara, we are helping change the world by aiding the development of novel medications through our technology-enabled solutions. Indeed, supporting the education of the next generation of pharmacometricians is essential to our mission. In … Continued

Certara Reinforces D360’s Position as Dominant Big Data Platform for the Biopharmaceutical Industry

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D360 version 8.0 supports connections to broader and more diverse data sets, increases collaboration across silos, and delivers faster time to insight for scientific decision making PRINCETON, NJ – Feb. 17, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that it will be launching version 8.0 of … Continued

Chemotherapy of Second Stage Human African Trypanosomiasis: Comparison Between the Parenteral Diamidine DB829 and Its Oral Prodrug DB868 in Vervet Monkeys

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Human African trypanosomiasis (HAT, sleeping sickness) ranks among the most neglected tropical diseases based on limited availability of drugs that are safe and efficacious, particularly against the second stage (central nervous system [CNS]) of infection. In response to this largely unmet need for new treatments, the Consortium for Parasitic Drug Development developed novel parenteral diamidines … Continued

Certara Staff to Demonstrate Drug Development Solutions at Scientific Webinar Series

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Topics to be presented will include PBPK modeling and simulation, population modeling of e-cigarettes, and artificial intelligence technology for clinical trial transparency. PRINCETON, NJ –  Feb. 6, 2015 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced that senior staff members from Certara will demonstrate their approaches to some of … Continued

Calculating the Elimination Rate Constant

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The elimination rate constant is the rate at which drug is cleared from the body assuming first-order elimination. Various abbreviations are used to represent the elimination rate constant including ke, kel, λ, and λz. The calculation of the elimination rate constant can be done using pharmacokinetic parameters or it can be done directly from a … Continued

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