The Certara Blog: PK/PD Modeling & Simulation

Introduction to Apocalyptic Clinical Pharmacology in Drug Development

Introduction to Apocalyptic Clinical Pharmacology in Drug Development

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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Clinical Pharmacology Gap Analysis - Lessons Learned

Clinical Pharmacology Gap Analysis: Lessons Learned

Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs. While gap analysis can be performed at any point in the drug development continuum, early engagement is best for maximizing its benefits. […]

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How to Maximize the Benefits of Clinical Pharmacology Gap Analysis

How to Maximize the Benefits of Clinical Pharmacology Gap Analysis

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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How Clinical Pharmacology Gap Analysis Can Create Value

How Clinical Pharmacology Gap Analysis Can Create Value

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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What are Clinical Trial Outcomes Databases? How and Why You Should Use Them

What are Clinical Trial Outcomes Databases? How and Why You Should Use Them

Publicly available clinical trial data represents an underutilized source of information. If properly extracted and analyzed, they provide valuable information to support drug development decisions. When you think of the volumes of public information and databases that are available to determine, for example, commercial viability of a therapeutic in development, your first inclination is—“great!” But […]

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Highlights of the Quebec Drug Discovery to Development Symposium

Highlights of the Quebec “Drug Discovery to Development” Symposium

In today’s drug development climate, we’re encouraged to “think global, act local.” I have had the privilege of supporting the development of important new therapies for clients around the globe. But sometimes, it is helpful to take a step back and look at the exciting science going on in your own backyard. With that spirit […]

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The Rise of Model-informed Drug Development in China

The Rise of Model-informed Drug Development in China

China’s pharmaceutical market is poised for growth. By 2020, it is expected to grow to approximately $120 billion. Today, China’s 1.36 billion people represent 20 percent of the world’s population. Yet, they comprise only 1.5 percent of the global drug market. From a demographic perspective, nine percent of the Chinese population today is over 65 […]

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How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients

How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients

Immuno-oncology, which harnesses the patient’s own immune system to fight cancer, is one of the hottest areas in drug development today. In recent years, the FDA has granted breakthrough therapy designations to multiple immuno-oncology drugs for a variety of oncology indications including advanced non-small cell lung cancer and melanoma. Over the last two decades, PK/PD […]

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The Anatomy of a Great Modeling and Simulation Project

The Anatomy of a Great Modeling and Simulation Project

In therapeutic areas with tough competition, it is challenging to establish a complete, confident understanding of a drug’s safety and efficacy profile. Any misunderstanding of a drug’s characteristics can derail the entire development program. Modeling and simulation, also known as model-based drug development, uses a number of techniques, such as population PK modeling, model-based meta-analysis, […]

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A Change of Heart at the Cardiac Safety Research Consortium

A Change of Heart at the Cardiac Safety Research Consortium

The ICH E14 guidance recommends that all new drugs with systemic bioavailability are assessed for the ability to delay cardiac repolarization as measured by the QT/QTc interval on the surface ECG. For most drugs, this evaluation is performed in the Thorough QT/QTc (TQT) study. Could using model-based approaches during routine early studies influence the current […]

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The Challenges of Determining Drug Dosing for Rare Diseases

The Challenges of Determining Drug Dosing for Rare Diseases

Most people are familiar with the leading causes of morbidity and mortality in the United States—heart disease, cancer, and diabetes. However, did you know that an estimated 350 million people worldwide suffer from rare diseases? In this blog post, I’ll be discussing what constitutes a rare disease, how developing orphan drugs to treat rare diseases […]

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