PK/PD 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
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