PBPK Modeling & Simulation

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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The Fantastic 4: Simcyp Rat, Mouse, Dog, and Monkey Simulators

June 27, 2019 – This webinar will explain how the Simcyp Animal Simulators support developing safer and more effective human and veterinary medications.

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Changing the Game in Oncology Drug Development and Patient Access

Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.

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PBPK for the Pill: An Approach to Assess the Risk-Benefit of Drugs

This webinar discussed how Certara’s PBPK platform, the Simcyp®️ Simulator, was used to assess the risk-benefit profile for ethinylestradiol, the estrogen component of most combined oral contraceptives.

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Development of a Physiologically-Based Pharmacokinetic Model for Topical Lidocaine in Order to Predict Systemic Absorption in Healthy Volunteers, Geriatrics, and Pediatrics

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Evaluation of Maternal Drug Exposure Following Administration of Dexamethasone and Betamethasone During Pregnancy Using Physiologically-Based Pharmacokinetic Modeling

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Certara Adds 4 Global Leaders to its Simcyp PBPK, QSP and QSTS M&S Division

New executives’ scientific, operational and consulting expertise will support Simcyp’s footprint in drug development and regulatory decision-making.

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Global Regulatory Agencies Increase Adoption of Phoenix PK/PD M&S Software for Drug Reviews

PRINCETON, NJ – Apr. 4, 2019- ANVISA, MHRA and PMDA join EMA, FDA, NMPA and TGA in expanding their Phoenix software licenses to evaluate drug regulatory submissions

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Computational Comparative Pharmacology: Designing Better Drugs for Animals (and Humans)

Modeling and simulation can help veterinarians provide better care for animals and guide research study design thereby maximizing the knowledge gained from research studies whilst minimizing the number of animals used. In this webinar, we looked at how PBPK modeling can be used to predict the absorption, distribution, metabolism, and excretion of drugs in humans and other animal species.

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Managing Immunogenicity Using Quantitative Systems Pharmacology

Posted by Piet van der Graaf

on Feb 22, 2019 1:46:07 PM

The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

PBPK’s Pivotal Role in Modern Drug Development: Busting Common Myths and Misconceptions

This white paper addresses common PBPK myths and misconceptions and demonstrates how this approach is an industrial and regulatory necessity in modern drug development.

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Certara Launches Version 18 of Its Physiologically-based Pharmacokinetic (PBPK) Simcyp Simulator

January 29, 2019 – New features designed to support the delivery of safer, more effective medications include advanced food staggering and tumor models for optimizing trial design and dose selection.

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Using Simcyp-guided ADME Biomarker Discovery to Prospectively Identify Patients at High Risk of Drug Toxicity

Posted by Thomas Polasek

on Jan 25, 2019 8:00:25 AM

As novel molecular targets are being continuously discovered and new treatments developed, oncology is one of the biggest therapeutic areas in precision medicine. In particular, new targeted anti-cancer medications that are taken orally, such as the protein kinase inhibitors (KIs), are ideal candidates for model-informed precision dosing (MIPD) technologies.1 One of these technologies is called physiologically-based […]

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

Lessons Learned: Case Studies of Apocalyptic Clinical Pharmacology

Posted by Graham Scott

on Dec 14, 2018 8:00:40 AM

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 […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

What’s New in the Simcyp Simulator v18?

Watch 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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Using Virtual Twin™ Technology to Predict Drug Exposure in Individual Patients

Posted by Thomas Polasek

on Nov 16, 2018 8:00:45 AM

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 […]

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

US FDA Awards Certara’s Simcyp Division Two New Dermal Virtual Bioequivalence Grants

PRINCETON, 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).

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