Modeling PK/PD Systems with Distributed Delays

Suzanne Minton

Many biological systems exhibit time delays. For instance, there is a delay between the time that a virus infects a cell and the onset of viral production. Mathematical models that incorporate these temporal delays are often used to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of drugs. In this blog post, I’ll discuss some examples of biological systems […]

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Topics: PK/PD Modeling & Simulation

Expanding the Use of Pharmacometrics in Japan with Yusuke Tanigawara

Suzanne Minton

Science is a global endeavor. Indeed, one of the most exciting things about drug development is working with scientists doing important research all over the globe. The use of modeling and simulation (M&S) to support drug development has been embraced by pharmaceutical researchers in some parts of the world and is still gaining traction in […]

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Topics: PK/PD Modeling & Simulation

Nurturing the Pharmacometricians of the Future

Suzanne Minton

As a scientist, you always remember your first conference. The ability to share your research and learn from your peers is an invaluable part of any scientist’s training. That’s why I’m so proud that Certara helps support the travel and accommodation expenses for a selected number of students wishing to attend the Population Approach Group […]

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

Obeticholic Acid – From PK Model to Drug Label

Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to understand the relationship between systemic and hepatic exposure of OCA in patients with and without hepatic impairment. By watching this webinar, you will learn how pharmacokinetic modeling can support optimal dosing for patients with organ impairment and facilitate regulatory approval.

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Using Pharmacokinetics to Assure Chemical Food Safety

Ronette Gehring

As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes, drugs are used to treat animals that are being raised for food (e.g., meat and milk). Therefore, tissue residues are a unique concern in veterinary medicine because indirect exposure to drugs and their metabolites through eating meat or milk could […]

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Topics: PK/PD Modeling & Simulation

Navigating the Path for Pharmacokinetic CDISC Data Preparation

Maria Saluta

Data heterogeneity is a regulatory reviewer’s nightmare. Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats? Do you use the American-style month-day-year format or the European-style day-month-year? Inconsistent data presentation makes both collaborating on drug development projects and reviewing regulatory submissions more difficult. To address this challenge, the […]

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Topics: PK/PD Modeling & Simulation

Quantify Osteoarthritis Pain Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for osteoarthritis pain. The current version of the database includes information on all systemic pharmacological interventions. This includes mono and combination therapy with NSAIDs, acetaminophen, opioids, COX-2 inhibitors, norepinephrine reuptake inhibitors, anti-NGF, anti-epileptic drugs (AEDs), antidepressants, and muscle relaxants.

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Quantify HBV Clinical Outcomes Database

The Quantify HBV Database is developed to document clinical safety and efficacy information on different nucleosides (eg, entecavir, lamivudine, tenofovir disoproxil fumarate, telbivudine, adefovir and combination) focusing on 3 different endpoints: HBV DNA time course, HBsAG time course, and HBeAG seroconversion that are available in the public domain.

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Quantify Chronic Lower Back Pain Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for chronic lower back pain. The current version of the database includes information on all systemic pharmacological interventions. This includes mono and combination therapy with NSAIDs, acetaminophen, opioids, COX-2 inhibitors, norepinephrine reuptake inhibitors, anti-NGF, anti-epileptic drugs (AEDs), antidepressants, and muscle relaxants.

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Quantify Neuropathic Pain Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for painful diabetic neuropathy (DPN), post herpetic neuralgia (PHN), or fibromyalgia. Information on older treatment options (such as tricyclic antidepressants) was included if they are used as active controls.

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