Regulatory & Medical Writing

Improve Your Approach to Sharing Clinical Trial Data

Kim Green

Transparency and disclosure of clinical trial data has been a hot topic, growing in prominence and strategic discussions over the past few years. Disclosing clinical trial information and creating transparency around clinical trial results are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur […]

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Topics: Regulatory & Medical Writing

The Best Meds for Man’s Best Friend: PBPK Models for Animal Health

Devendra Pade

When people find out that you’re working to improve drug development for companion animals, you hear some colorful stories. The other day, one of my colleagues recounted to me the wild antics of Jinjer, her childhood dog. Jinjer was a 60 pound, fawn boxer, with a tiny stump of a tail, who loved everyone. This […]

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Topics: PBPK Modeling & Simulation

How Pharmacometric Analyses Can Add Value to Oncology Drug Programs

Suzanne Minton

We are standing on the precipice of a new era in oncology drug development. In his Pulitzer prize winning book, The Emperor of All Maladies: A Biography of Cancer, Dr. Siddhartha Mukherjee traces the evolution of the approach to treating cancer. He identifies four major paradigms in our understanding of this disease: Ancient views of […]

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

Derivation for Logarithmic Trapezoidal AUC Calculation

Nathan Teuscher

Calculating area under the curve requires the use of two separate equations: one is follows the “linear trapezoidal rule” and the other follows the “logarithmic trapezoidal rule.” These equations are normally presented in textbooks without derivations so all you have to do is insert the concentrations and times and you can calculate the area under […]

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Topics: PK/PD Modeling & Simulation

That’s So Meta: How Model-based Meta-analysis Informs Drug Development

Mark Lovern

Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publically available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into […]

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Topics: Model-based Meta-analysis