PK/PD Modeling & Simulation

Common Misconceptions About Computer System Validation

Debra Fontana

Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and pharmacodynamics (PD) of an investigational drug. To satisfy regulatory expectations, these computer systems should be validated. As a recent article points out, failure to do computer system validation for the software functionality that a user intends to use, with data […]

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Topics: PK/PD Modeling & Simulation

Clinical Data Transparency Mandates Are Reshaping Regulatory Writing

Keith Kleeman

New European and U.S. clinical trial data transparency initiatives—such as EMA Policy 70, which goes into effect this month—are creating additional disclosure compliance requirements for pharma and biotech companies. In this blog post, I’ll discuss the implications of these data transparency initiatives and present how Synchrogenix, powered by ClinGenuity and a Certara company, is addressing this emerging […]

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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing

Using Biosimulation to Quantify the PK of an Anti-HIV Drug for Babies

Martin Beliveau

As a scientist at Certara and proud Dad to my three kids, pediatric drug development is a topic that is near to my heart. Clearly, children are not just “small adults.” They require special consideration for their distinct physiology during drug development. Likewise, for ethical reasons, it is important to minimize children’s exposure to experimental […]

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Topics: PK/PD Modeling & Simulation

Strategic Regulatory Writing for Drug Development Success

Kelley Kendle

Happy New Year! The start of a new year brings the promise of new opportunities for growth—both personally and professionally. As the CEO for Synchrogenix, Certara’s regulatory writing consultancy, I’ve been thinking a lot lately about how changes in the regulatory writing landscape will shape the drug development process in 2015. It’s becoming more and more […]

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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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