PK/PD Modeling & Simulation

Heartbreaking Works of Staggering Genius: Cardiac Safety for Oncology

Michael Eckstut

I could give you some of facts and figures about cancer. Like the fact that the American Cancer Society estimates there will be 1,658,370 new cancer cases diagnosed and 589,430 cancer deaths in the US this year. Or that pancreatic cancer has only a 5-year survival rate of 5%. But, these statistics belie the heartbreaking reality […]

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Topics: PK/PD Modeling & Simulation

Predicting mAb Pharmacokinetics in Humans with a Minimal PBPK Model

Iain Gardner

Monoclonal antibodies (mAbs) and their derivatives are a rapidly growing segment of the pharmaceutical industry’s pipeline. In fact, more than 40 mAbs and derivatives have been approved for a variety of therapeutic applications; around 500 mAbs and derivatives are currently in different stages of development. Monoclonal antibodies have pharmacokinetic (PK) properties that are quite distinct from that […]

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Topics: PBPK Modeling & Simulation

Meet FDA Bioequivalence Criteria with WinNonlin RSABE Templates

Ana Henry

A study by the FDA Office of Generic Drugs (OGD) reviewed over 1000 bioequivalence (BE) studies of 180 drugs, of which over 30% were highly variable (HV). Because of this high variability, studies designed to show whether generic HV drugs are bioequivalent to their corresponding HV reference drugs may need to enroll large numbers of […]

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Topics: PK/PD Modeling & Simulation

Supporting Pharmacometrics Education at the University of Maryland

Ellen Leinfuss

Nelson Mandela is quoted with saying, “Education is the most powerful weapon which you can use to change the world.” At Certara, we are helping change the world by aiding the development of novel medications through our technology-enabled solutions. Indeed, supporting the education of the next generation of pharmacometricians is essential to our mission. In […]

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Topics: PK/PD Modeling & Simulation

Positive Stats About PK/PD Modeling in the Pharmaceutical Industry

Suzanne Minton

Pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation (M&S) is an important tool that can help researchers gain a better understanding of their drug’s efficacy— especially at the early stages of drug development. In this blog post, I’ll discuss some positive statistics uncovered in a recent IQ Consortium survey that examined the current landscape for preclinical PK/PD modeling […]

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

Fighting Superbugs: Supporting FDA Approval of a New Antibiotic

Michael Eckstut

One of the most rewarding parts of leading Certara’s consulting services is recognizing how our work supports new drug approvals to positively impact patients’ health. In this blog post, I’ll discuss how Certara helped Cubist obtain FDA approval for Zerbaxa™ (ceftolozane/tazobactam), a new antibacterial drug to treat adults with complicated infections. The growing threat of […]

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Topics: PK/PD Modeling & Simulation

Calculating the Elimination Rate Constant

Nathan Teuscher

The elimination rate constant is the rate at which drug is cleared from the body assuming first-order elimination. Various abbreviations are used to represent the elimination rate constant including ke, kel, λ, and λz. The calculation of the elimination rate constant can be done using pharmacokinetic parameters or it can be done directly from a […]

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Topics: 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 Modeling and Simulation 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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