Pirana

Pirana is a flexible and extendible modeling workbench with an intuitive graphical user interface for facilitating pharmacometric workflows for NONMEM, PsN, Xpose/R, and more. Pirana’s research tools facilitate the iterative processes used to create Pop PK/PD models, resulting in better organization and more efficient analysis of results.

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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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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

Piet van der Graaf

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

A Beginner’s Guide to Performing Clinical Trial Simulation

Mark Lovern

The astronomical cost of conducting clinical drug trials means that a suboptimal trial design adds significant risk to a drug program. Clinical trial simulation allows drug developers to test different trial designs in silico before exposing patients to an experimental drug. In this blog post, I’ll explain how Certara’s Trial Simulator balances ease-of-use with robust […]

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Topics: PK/PD Modeling & Simulation

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

Thomas Polasek

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

Trial Simulation: An Innovative Approach to Assess Pediatric Drug Dosing

Edward Nehus

As a pediatric nephrologist, I help care for some very sick kids. And because our young patients are so ill, it’s a challenge to recruit them into clinical studies. Of course, we want to provide our patients with the best care; getting the dose right on their medications is a big part of that. However, […]

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Topics: PK/PD Modeling & Simulation

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

Thomas Polasek

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
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