Drug Safety/Pharmacovigilance Featured Articles
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The Real Miracle Of Drug Development: Immunity From Inflation!
2/12/2016
They say there are two certainties in life: death and taxes. If we were to add a third certainty to that list, it might be that we generally have inflation as well. But if rising prices on consumer goods are a fact of life, why are some people surprised when the cost of prescription drugs increase as well?
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Health Experts Weigh In On Zika Risks And Potential For Future Outbreaks
2/10/2016
With the Zika virus spreading in the Americas, the outbreak and potential for future outbreaks in other areas of the world has many health professionals and organizations concerned. The European Society of Clinical Microbiology and Infectious Diseases (ESCMID), which promotes research, risk assessment, knowledge sharing, and best practices in the fight against infectious diseases, is one of those organizations.
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What You Need To Know About FDA’s Clinical Outcome Assessment Compendium
2/8/2016
One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.
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Using The Cost Of Adverse Events To Determine Drug Safety
2/3/2016
There are limitations to the drug approval system we currently have in place that is based on clinical trials. Data disclosures are often deemed inadequate, regulatory review and approval can be a lengthy process, and many would argue there is a bias in the industry and academia against publishing negative results.
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Report: EMA Recommendations Were Not Followed In France
2/1/2016
ANSM, the national drug safety agency in France, has issued a timeline of the events that culminated in the death of one trial participant and the hospitalization of five others at a clinical trial performed at clinical research firm BIOTRIAL. As was speculated by researchers at the UK’s Royal Statistical Society (RSS) last week, the timeline confirms that all six of the volunteers who were hospitalized after the study received an escalation of the dose at the same time.
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Did Poor Protocol Design Lead To The Clinical Accident In France?
1/25/2016
Did the clinical trial in France that has left one person dead and several others hospitalized have flaws in the protocol design? While we continue to await new information on what may have caused the tragedy, some researchers are already speculating on whether or not the design of the trial may have been a factor, and are demanding more information be released.
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Could The RESULT Act End The FDA's Monopoly On Drug Approval?
1/22/2016
A new bill introduced in December 2015 seeks to end the FDA monopoly on drug approvals in the U.S. The RESULT (Reciprocity Ensures Streamlined Use of Lifesaving Treatments) Act, introduced by two republican senators, seeks to bring some needed help to the overburdened agency while at the same time getting needed medicines and medical devices to patients faster.
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Is There A Link Between The France Tragedy And Legal Highs?
1/20/2016
By now you have heard about the tragic clinical trial in France that has resulted in the death of one person and the hospitalization of four others. While full details of what caused the fatal death of a healthy man are still not available, we do know the trial was likely testing an FAAH-inhibitor. Maia Szalavitz, writing on the website Vice.com, says this should be a wakeup call to some legal substance users in the U.S.
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What Went Wrong In France?
1/15/2016
According to news reports, a drug undergoing testing in a French clinic has left one patient dead and four others critically ill, two that may have permanent brain damage. The drug has thus far been unnamed, but it appears to have been produced by the Portuguese company Bial. The French health minister has stated the drug acted on natural receptors found in the body known as endocannibinoids, which regulate mood and appetite.
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Quantitative Systems Pharmacology Brings Value To Drug Development
1/12/2016
Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.