Clinical Pharmacology Strategy

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

How Modeling and Simulation Technology Impacted the “Class of ’15”

Ellen Leinfuss

It’s been almost 20 years since the FDA approved a group of New Drug Applications (NDA) and Biologic License Applications (BLA) as large as the class of ’15. The 45 approved drugs represent a 10% increase over the prior year and an increase of 114% from the beginning of the decade. What accounts for this […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Is the Maturation of Quantitative Systems Pharmacology a Moonshot?

Mark Hovde

At Certara, we are not afraid to think big. In fact, solving the hardest problems in pharmaceutical R&D is our passion. You might say that some of our ambitions could be described as “moonshots.” After all, they meet the criteria put forth by the Google X moonshot program. We seek to address the huge problem […]

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Topics: Systems Pharmacology

Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland

Suzanne Minton

Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation of a mechanistic understanding of pharmacokinetics since the 1960s. So you might think that he’d be ready for quieter pursuits. But this professor emeritus at the University of Manchester has no plans to stop actively teaching and guiding the pharmaceutical industry’s […]

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Topics: PBPK Modeling & Simulation

Tips for Custom IVIVC Models in Phoenix

Simon Davis

The IVIVC tool within Phoenix is a convenient and powerful tool to build an in vivo-in vitro correlation model using dissolution experiments and real in vivo profiles. This module can support your organization in formulation development and even in applying for biowaivers. The tool has a flexible library of built-in models that can be modified […]

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Topics: PK/PD Modeling & Simulation

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

Rik de Greef

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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Topics: PK/PD Modeling & Simulation

Conventional & Mechanistic IVIVC: Complementary or Clashing Methods?

Venkateswari Muthukrishnan

An IVIVC (in vitro-in vivo correlation) is a mathematical relationship that predicts key pharmacokinetic parameters (Cmax, AUC) from in vitro dissolution data. Drug developers use IVIVCs for 3 major reasons: To serve as a surrogate for human bioequivalence (BE) studies To support and/or validate the use of dissolution methods and specifications To assist in quality […]

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Topics: PK/PD Modeling & Simulation

Seeing the Strategic Value of Modeling and Simulation Technology

Mark Hovde

They say beauty is in the eye of the beholder. One could also say that the benefits of modeling and simulation (M&S) are in the eye of the beholder. How does the beholder, in this case, a drug developer, see the benefits of these approaches? All reputable businesses use “generally accepted accounting principles” to manage, […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Insights on Quantitative Systems Pharmacology with Piet van der Graaf

Suzanne Minton

Quantitative systems pharmacology (QSP) is an emerging biosimulation technology that is going to increase pharmaceutical R&D productivity. This week at the Roundtable, we’re talking with Dr. Piet van der Graaf, PharmD, PhD about QSP and his vision for how it supports meeting the goal of precision medicine. Dr. van der Graaf is a professor of […]

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Topics: Systems Pharmacology

Pharma Leaders in China Embrace Simcyp Science

Bo Liu

Will the 21st century go down in history as the “Chinese Century”? If the status of its pharmaceutical industry is a barometer for China’s global position, then the answer may be “yes.” The size of the Chinese pharmaceutical market is second only to the US. In 2014, it was worth $105 billion. By 2020, the […]

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Topics: PBPK Modeling & Simulation

7 Horrible Mistakes You’re Making with Your Drug Development Strategy

Mark Hovde

In thinking about the complex nature of drug development, I’m often reminded of a Dwight Eisenhower quote: “In preparing for battle, I’ve always found that plans are useless, but planning is essential,” Drug development is a risky business. According to a 2014 study from the Tufts Center for the Study of Drug Development, “the estimated […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing

The Year in Review for Modeling and Simulation and Regulatory Writing

Suzanne Minton

Happy New Year! 2015 was a year of huge growth—both personally and professionally—for our Certara® family. We’re so grateful for our clients who give us the privilege of supporting them in their work to bring safer and more effective treatments to patients. In this blog post, I’ll be looking back at the top 10 most popular […]

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Topics: PBPK Modeling & Simulation, Regulatory & Medical Writing
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