PBPK Modeling & Simulation

A Chat with Biopharmaceutics Expert, Professor Jennifer Dressman

Suzanne Minton

Professor Jennifer Dressman is fearless—both in her science and her career. Born and raised in Australia, she holds degrees in pharmacy and a doctorate in pharmaceutics. Having held positions at Burroughs Wellcome and the University of Michigan, College of Pharmacy in the United States, she was offered her dream job as a professor at the […]

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Topics: PBPK 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

Agreeing to Submission Document Timelines and Sticking to Them: Fairy Tale or Reality?

Steve Sibley

Does the thought of developing a submission for the marketing approval of a new drug fill you with dread? How do you avoid losing all of your holidays and weekends when developing a submission? Or burning out your team? In my career, I’ve helped teams develop robust submissions with minimal disruption to people’s lives and […]

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Topics: Regulatory & Medical Writing

FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Ellen Leinfuss

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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