Building an MBMA Framework to Support Developing New Neuropathic Pain Drugs

April 24, 2019 – Model-Based Meta-Analysis (MBMA) is a growing methodology that leverages literature based and often external data to provide a quantitative framework to enable strategic drug development decisions. MBMA comparator models often include valuable pieces of information such as time, covariates, clinical trial efficacy and safety information.

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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

Introduction to Apocalyptic Clinical Pharmacology in Drug Development

Graham Scott

In this blog, I will introduce “apocalyptic clinical pharmacology” and provide a framework for using this approach in drug development, which can save resources and time. Apocalyptic clinical pharmacology in drug development provides value offering a framework for thinking about the relationship between the drug dose and the biological system. What is apocalyptic clinical pharmacology? […]

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

Answers to Your Burning Questions on Level C IVIVC

Jean-Michel Cardot

In vitro-in vivo correlation (IVIVC) technology allows formulation and manufacturing (CMC) professionals to understand how dissolution parameters affect in vivo drug performance. IVIVC can be performed at one of three levels—A, B, and C. Getting the most out of this tool requires knowing when and how to use which level of IVIVC. Here are some […]

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Topics: PK/PD Modeling & Simulation
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