Mind the Gap: Best Practices in Clinical Pharmacology Gap Analysis

Julie Bullock

Do you get anxious about taking tests? Many people do because they want to show their best efforts. Submitting your New Drug Application (NDA) to the FDA can be thought of as the ultimate test of a drug program. Are you confident that you’ll have robust answers to the 40 different questions that the agency […]

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Topics: Clinical Pharmacology Strategy

How Model-informed Drug Development Will Increase R&D Productivity

Suzanne Minton

Will 2017 finally be the year that we overcome the blight of late-stage attrition of promising drug candidates? In a recent commentary, “Improving the Tools of Clinical Pharmacology: Goals for 2017 and Beyond,” in Clinical Pharmacology & Therapeutics, Issam Zineh and colleagues describe several areas where clinical pharmacology approaches can help reduce late-stage attrition and […]

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Topics: Clinical Pharmacology Strategy, Systems Pharmacology

Revolutionizing Drug Development—d3 Medicine Joins the Certara Family

Craig Rayner

Thinking Without BordersTM Developing Medicines that MatterTM These guiding principles fueled the creation of d3 Medicine. With a goal of revolutionizing the pharmaceutical paradigm to accelerate developing medicines that benefit society, combining d3 and Certara was a ‘no brainer.’ Delivering on our clients’ mission The d3 Medicine staff join Certara’s Strategic Consulting (CSC) division, which […]

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Topics: Clinical Pharmacology Strategy

Quantitative Pharmacology Strategies for Pediatric Drug Development

Patrick Smith

Pediatric patients are not simply small adults. Children differ from adults in both disease pathophysiology and pharmacokinetics/pharmacodynamics (PK/PD). Yet historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. In this blog post, I’ll discuss the challenges of developing drugs for children and explain how quantitative pharmacology […]

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

What is Model-based Drug Development Worth?

Mark Hovde

If you have ever argued, as we have, for the resources and time needed for model-based drug development (MBDD), you have likely encountered that irritating accountant in the room who says, “Sure, this modeling stuff sounds interesting, but how much MONEY will this save us?” My answer: $97M of savings per New Drug Application (NDA). […]

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Topics: Clinical Pharmacology Strategy

Trial Designs—Non-inferiority vs. Superiority vs. Equivalence

Nathan Teuscher

The primary purpose of a clinical trial is to address a scientific hypothesis. To address a hypothesis, different statistical methods are used depending on the type of question to be answered. Most often the hypothesis is related to the effect of one treatment as compared to another. For example, one trial could compare the effectiveness […]

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Topics: Clinical Pharmacology Strategy
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