Certara at AAPS PharmSci 360

AAPS Posters

Certara Scientific Posters at AAPS PharmSci 360 Presented on Monday, November 5 M1230-05-033: Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix® WinNonlin® Ana Henry, Christopher Mehl, Linda Hughes M1230-05-036: Multi-phase Multi-layer Mechanistic Physiologically-based Pharmacokinetic Dermal Absorption Model Verification Including Inter- and Intra-Individual Variability Assessment […]

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Trial Simulator

Certara Trial Simulator version 2.3 Powerful, Flexible, and Intuitive 9 out of 10 drugs in development fail to make it to market, costing pharmaceutical companies billions every year.1 One reason for these failures is suboptimal clinical trial design.1,2 Certara’s Trial Simulator has been trusted by leading pharmaceutical companies for over a decade to optimize trial design and […]

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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

ACoP Posters

Certara Scientific Posters at ACoP9 Presented on Monday, October 8 M-005: A Model-based Meta-analysis to Support Development of Drugs for Treatment of Diabetic Peripheral Neuropathy (DPN), Post Herpetic Neuralgia (PHN) and Fibromyalgia Richard Franzese, Mark Lovern (contributing authors) M-037: Physiologically-based Pharmacokinetics Model Application for Epacadostat to Estimate Starting Doses for Pediatric Clinical Evaluations Alice Ke […]

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Certara Software or Services Supported 95% of the US FDA Novel Drug Approvals in First Half of 2018

PRINCETON, NJ – Aug. 2, 2018 – Certara today reported that 95% of novel new drug approvals by the US Food and Drug Administration (FDA) in the first half of 2018 were supported by Certara software or services. Those results emphasize how much modeling and simulation has become an integral part of regulatory submissions and highlight Certara’s leadership role in the field.

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Accomplish More with Phoenix

Venkateswari Muthukrishnan

Phoenix 8.1, the newest version of Certara’s innovative PK/PD modeling and simulation software used globally by researchers and drug developers in pharma, academia, and regulatory agencies, will be available on June 15, 2018. Major enhancements were introduced in the Phoenix workbench last year. And as an ongoing commitment to support compliance and efficiency, many features […]

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Topics: PK/PD Modeling & Simulation

Accomplish More with Phoenix—New Phoenix 8.1 Release in June 2018!

As the gold standard for PK/PD software, our upcoming Phoenix 8.1 release delivers new capabilities to automate processes, reduce errors, and save you time. Dr. Nathan Teuscher, VP of Pharmacometric Consulting, Venkateswari Muthukrishnan, Phoenix WinNonlin Product Manager, and Ana Henry, Executive Director of Training, shared our latest innovations in WinNonlin and NLME and conducted a live demo.

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Spotlight on the PAGE Student Sponsorship Winners

Suzanne Minton

When I attend scientific conferences, I feel as though I have reached my own personal “Nerdvana.” I love everything about them! I love going to the sessions and learning the latest cutting edge insights from the leaders in our field. I love walking the aisles of posters and getting to talk one-on-one with scientists about […]

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Topics: PK/PD Modeling & Simulation

Certara Professional Certification Program

Get Certified with Certara’s Professional Certification Program Certara Professional Certification is an online accreditation of user competency and proficiency in analysis of PK/PD data using Certara software such as Phoenix WinNonlin, Phoenix NLME, etc. Earning a Certara Professional Certification provides validation that the necessary skills to perform PK/PD analysis using the industry-leading software have been […]

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Achieving Compliance with the FDA’s eCTD Mandate

Rob Labriola

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, […]

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Topics: Regulatory Submissions Management

Ready, Set, Model! Take PK/PD Analysis to New Heights with Phoenix 8.0

Maria Saluta

Dr. Scott Gottlieb, the Commissioner of Food and Drugs, has outlined the steps the US FDA will take to implement the 21st Century Cures Act. In outlining the plan, the Commissioner endorses modeling and simulation approaches to increase the efficiency of drug development. Certara has launched Phoenix® 8.0, the latest version of the innovative PK/PD […]

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Topics: PK/PD Modeling & Simulation

Using Virtual Cancer Patients to Probe the Mechanisms of Oncology Drug Disposition

Oliver Hatley

Oncology drug developers face a distinct set of challenges. Oncology drugs are often very toxic which precludes conducting clinical trials in healthy volunteers. In addition, cancer patients differ from healthy people in terms of their demographics and physiology. These changes mean that the pharmacokinetics of drugs may be altered in this population compared to healthy […]

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Topics: PBPK Modeling & Simulation

A Practical Approach to the Challenges of Pediatric Drug Development

Barry Mangum

Drug developers can’t take an adult clinical trial protocol and simply retool it for pediatrics. Yet, in my work at a pediatric clinical research organization (CRO), I frequently see sponsors attempt to do just that. Successfully implementing a pediatric drug development plan poses challenges regarding trial planning, design, and conduct. In this blog post, I’ll […]

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

Modeling & Simulation Take a Prominent Role in FDA’s Newly Published DDI Guidances

Ellen Leinfuss

On October 25, 2017, the FDA published two new guidance documents on drug-drug interactions (DDI). These guidance documents replace the February 2012 guidance, “Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.” According to the FDA, these new guidances reflect the agency’s current thinking and greater learnings on DDI and provides a […]

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Topics: PBPK Modeling & Simulation

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

Phoenix 8.1

Phoenix PK/PD Modeling and Simulation Software Certara’s Phoenix platform is the leading PK/PD modeling and simulation software used worldwide by 6,000 researchers at biopharmaceutical companies, academic institutions, and global regulatory agencies, including eleven divisions of the US FDA. Phoenix extends the winning formula of WinNonlin by combining its trusted algorithms with built-in, easy-to-use graphical user […]

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