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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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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Pharmacokinetics of a Single Dose of Oral and Subcutaneous Meloxicam in Caribbean Flamingos (Phoenicopterus ruber ruber)

To determine the pharmacokinetics of meloxicam in Caribbean flamingos ( Phoenicopterus ruber ruber), a pilot study was performed first, followed by a complete pharmacokinetic study. Four healthy birds were divided into 2 groups and administered 1 mg/kg of either oral (n = 2) or subcutaneous (n = 2) meloxicam. Plasma meloxicam concentrations were determined with […]

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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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Development of a Permeability-limited Model of the Human Brain and Cerebrospinal Fluid (CSF) to Integrate Known Physiological and Biological Knowledge: Estimating Time Varying CSF Drug Concentrations and Their Variability Using In Vitro Data

A 4-compartment permeability-limited brain (4Brain) model consisting of brain blood, brain mass, cranial and spinal cerebrospinal fluid (CSF) compartments has been developed and incorporated into a whole body physiologically-based pharmacokinetic (PBPK) model within the Simcyp Simulator. The model assumptions, structure, governing equations and system parameters are described. The model in particular considers the anatomy and […]

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Meta-analysis of thoracic epidural anesthesia versus general anesthesia for cardiac surgery

A combination of general anesthesia (GA) with thoracic epidural anesthesia (TEA) may have a beneficial effect on clinical outcomes after cardiac surgery. We have performed a meta-analysis to compare mortality and cardiac, respiratory, and neurologic complications in patients undergoing cardiac surgery with GA alone or a combination of GA with TEA. Randomized studies comparing outcomes […]

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Learning from Failure: Leveraging Biosimulation for Pediatric Drug Development Success

The high rate of trial failures, increasing regulatory demands, and ethical imperatives all require a reexamination of the current approach to pediatric drug development. Biosimulation is a proven approach that will help optimize trial design and inform the drug label. This approach can support global regulatory strategies that increase the likelihood of success for pediatric drug development programs.

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Can QSP Save Lives? Lessons from the Bial Trial Debacle

One of the biggest challenges for the pharmaceutical industry is the high rate of drug attrition in Phase 2 clinical trials, which wastes significant amounts of money and time. The major reasons for this attrition are that either candidate drugs do not show efficacy or have unexpected toxicity, in turn implying that we did not fully understand the complexity of the biology the candidate drugs were designed to modulate.

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