PBPK Modeling & Simulation

The Biggest Drug Development News Stories in 2017

Suzanne Minton

When I reflect on the state of drug development in 2017, the opening lines of Charles Dickens’ A Tale of Two Cities comes to mind. It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, […]

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

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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Using Virtual Twin Technology to Predict Drug Exposure in Individual Patients

March 8, 2018 – In this webinar, Dr. Tom Polasek, a clinical pharmacologist at Certara Strategic Consulting, will explain how he used the Simcyp Simulator to predict olanzapine exposure in individual patients. By attending this webinar you will learn how PBPK modeling and simulation technology can be re-purposed to support model-informed precision dosing.

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Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

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The Pharmacokinetics of Transdermal Flunixin Meglumine in Holstein Calves

This study describes the pharmacokinetics of topical and intravenous (IV) flunixin meglumine in Holstein calves. Eight male Holsteins calves, aged 6 to 8 weeks, were administered flunixin at a dose of 2.2 mg/kg intravenously. Following a 10-day washout period, calves were dosed with flunixin at 3.33 mg/kg topically (transdermal). Blood samples were collected at predetermined times from 0 […]

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Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug

Karen Rowland Yeo

Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety and efficacy. These factors include intrinsic variability― CYP metabolizer status, age, sex, renal/hepatic impairment― as well as external variables― co-medications, food effects, smoker status, etc. Clinical trials alone […]

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Topics: PBPK Modeling & Simulation

Can QSP Save Lives? Lessons from a Trial Debacle

Neil Benson

The notion that volunteers could be harmed in a clinical trial is every drug developer’s worst nightmare. Earlier this year, the drug company, Bial, investigated inhibitors of the enzyme fatty acid amide hydrolase (FAAH) in clinical trials as a treatment for pain. Tragically, one person in the volunteer group died, and six patients were hospitalized. […]

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Topics: Systems Pharmacology
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