Phoenix

Phoenix

Phoenix PK/PD Modeling and Simulation Software   Certara’s Phoenix® platform is the leading PK/PD modeling and simulation software used worldwide by more than 6,000 researchers at biopharmaceutical companies, academic institutions, and global regulatory agencies, including eleven divisions of the US FDA. Phoenix includes WinNonlin™, the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic […]

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Integral: Next Generation Data Repository

Certara Integral™ is a single, validated, 21 CFR Part 11 compliant data repository that streamlines clinical pharmacology workflow Secure and pre-validated technology provides a single source of truth for your data providing multiple benefits Make data-driven decisions earlier in the development process Increase clinical pharmacology efficiencies Successfully pass audits by regulatory agencies Be confident in […]

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Page Posters 2019

Certara Scientific Posters at PAGE Presented on Wednesday, June 12th – 9:50am – 11:15am I-03:  Integrating a Tumour Growth inhibition Model within a Physiologically-Based Pharmacokinetic Model to Predict Erlotinib Tumour Concentrations in Mice Khaled Abduljalil, Rachel H. Rose, Devendra Pade, Siri Kalyan Chirumamilla, Cong Liu, Isha Taneja, Anthonia Afuape, Linzhong Li, Iain Gardner I-13:  Predicting […]

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Certara’s Simcyp PBPK M&S Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

PRINCETON, NJ – June 12, 2019 – Certara’s Simcyp®️ physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) for the US Food and Drug Administration (FDA) approval of a complex generic drug on the agency’s abbreviated new drug application (ANDA) pathway.

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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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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

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