PBPK Modeling & Simulation

How to Optimize Your Drug Label Using Biosimulation Technology

Steve Toon

As a trained pharmacist and scientist, I think a lot about patient care and how the drug development process impacts drug labels and the clinical use of medicines. Biosimulation technology encompasses methods such as physiologically based pharmacokinetic (PBPK) models. PBPK provides insight into drug mechanisms. It also helps clinicians provide the safest and most effective […]

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Topics: PBPK Modeling & Simulation

Regulatory Writing Experts Can Make You a Lean, Mean Pharma Machine

Kelley Hill

Getting your body into shape has a lot in common with helping implement regulatory medical writing best practices at a biopharmaceutical organization. Specifically, there are a number of similarities between engaging a regulatory writing consultancy and hiring a physical trainer. Unlike “Hans and Franz” of Saturday Night Live fame, who just want to “Pump YOU […]

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Topics: Regulatory & Medical Writing

9 Things Your Boss Wishes You Knew About PK/PD Modeling

Nathan Teuscher

Over the course of my career, I have taught the theory and practical applications of PK/PD modeling to hundreds of scientists. In this blog post, I’ll share some of my most popular tips for solving common difficulties encountered by pharmacometricians. The tools of the trade While I have worked with a number of pharmacometrics tools, I […]

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Topics: PK/PD Modeling & Simulation

The Future is Now: How 3D Printing Could Deliver Personalized Medicine

Adam Calderon

“It will take a few minutes to upload the instructions for your prescription to the 3D printer. We will call you once your medication is ready to be picked up.”  While it seems like science fiction, your pharmacist may describe filling your prescription using this emerging technology sooner than you might think. In this blog […]

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Topics: PK/PD Modeling & Simulation

The Anatomy of a Great Biosimulation Project

Nastya Kassir

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. Biosimulation, also known as model-based drug development, uses a number of techniques, such as population PK modeling, model-based meta-analysis, and PBPK […]

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Topics: PK/PD Modeling & Simulation
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