PK/PD Modeling & Simulation

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

Using M&S to Evaluate Oncology Drug Dosing

Maria Saluta

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk […]

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

Certara’s Best of the Blog 2017

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

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Using a Pharmacology to Payer Framework to Support Product Development

C. Kirkpatrick, C. Rayner

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, […]

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Topics: Clinical Pharmacology Strategy

How to Maximize the Benefits of Clinical Pharmacology Gap Analysis

Julie Bullock

Many companies have tried and true clinical pharmacology practices. But when the rubber hits the road for your drug program, will these practices support regulatory success? Has your historic approach to drug development been updated to include the latest modeling and simulation innovations? It’s hard to change how you’ve historically done things. But, do you […]

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

How to Plan and Implement a Pharmacology to Payer Framework

C. Kirkpatrick, C. Rayner

Pharmacology to the payer (P2P) is an innovative approach to create a framework for dialogue between drug sponsors, regulators, and payers. The core structure is the sequential linking of quantitative mathematical models—pharmacology, pharmacokinetics/pharmacodynamics (PK/PD), disease progression, epidemiology, health utilization, and health economics. In this blog post, we discuss how working with an amazing team of […]

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Topics: Clinical Pharmacology Strategy

Apocalyptic Clinical Pharmacology: A Comprehensive Approach to Drug Development

Watch this webinar with Dr. Graham Scott, Senior Director of Clinical Pharmacology at Certara Strategic Consulting, to learn why you should invest in “apocalyptic clinical pharmacology.” Dr. Scott presented case studies that illustrate how sponsors can benefit from a clinical pharmacology strategy that uses model-informed approaches to inform and “fill in the gaps” of clinical trials.

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Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions

Maria Saluta

Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and regulators also need to determine how to best utilize and report modeling and simulation results […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Regulatory Submissions Management

How Clinical Pharmacology Gap Analysis Can Create Value

Julie Bullock

During my years reviewing applications for the US FDA, I encountered a lot of poor planning concerning a drug’s clinical pharmacology program. This poor planning left the company either lacking data to make informed decisions or scrambling at the end of development to address unanswered issues. Early planning is key to regulatory success, not only […]

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

Pharmacology to Payer: One Quantitative Drug Development Framework to Rule Them All

Craig Rayner

In JRR Tolkien’s Lord of the Rings, the power of the one ring forged by the evil sorcerer, Sauron, is used to control all of the disaggregated, independent kingdoms of Middle Earth. Similarly, but without the malice, the “pharmacology to the payer” (P2P) quantitative framework can be viewed as a way to unite and connect […]

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Topics: Clinical Pharmacology Strategy

Using Model-informed Drug Development Approaches to Accelerate Orphan Drug Development

Maria Saluta

Orphan drugs are used to treat rare diseases and disorders. This year marks the 35th anniversary of both the landmark Orphan Drug Act, a law passed by the US FDA that created legal and financial incentives for pharma and biotech to pursue rare disease R&D, and the formation of the National Organization for Rare Disorders […]

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

The European Regulatory Landscape for Pediatric Drug Development

Barry Mangum

In my 35 years of working to develop safer, more effective medications for children, I’ve often been asked about how to navigate the regulatory landscape in the US and Europe. In a previous blog post, I discussed the latest FDA trends regarding pediatric drug development. In this blog, I’ll focus on the path for achieving […]

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