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Search Results for "Post Marketing Safety Studies"

08:40 EDT 21st May 2013 | BioPortfolio

Original Source: Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination

The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases (AIDs) following females who have received at the least the first dose of Cervarix® as part of their routine health care.

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Alto Marketing - specialist healthcare and life science communications consultancy

Alto Marketing is a committed and forward-thinking specialist healthcare and life science communications consultancy.  With extensive experience of worldwide marketing in sectors including (...

Clinical Approvals - news, views, reports and blogs

Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and eff...

Safety

Safety and efficacy

Clinical Trials Phase News

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will norma...

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BMJ: diabetes post-marketing studies used to boost sales

The use of post-marketing studies for diabetes is being used to sell more medicines rather than for science, according to a new investigation by the BMJ. Post-marketing studies are primarily used to s...

Going a step Further: Phase IV and Post-Marketing Observational Studies add Value to new Therapies, life Science Webinar Hosted by Xtalks

Toronto, Canada (PRWEB) April 23, 2013 The intrinsic differences between clinical trials and real-life drug treatment create safety gaps that can undermine the overall benefit for patients and valu...

Post-Marketing Studies Of New Diabetes Therapies - What Are The Motives?

A new BMJ investigation raises questions behind the motives used for post-marketing studies of new diabetes therapies. To ensure "a proper balance" between commercial and clinical functions, the BMJ d...

Post-marketing studies can make important contributions to medical knowledge

My experience in collaborating with various drug companies in the design, execution, analysis, and publication of post-marketing surveillance (PMS) studies differs greatly from that described in your....

FDA Clearing Backlog Of Post-Marketing Studies, But Progress May Slow

While more than half of the post-marketing commitment backlog from 2007 and earlier has been cleared from FDA’s books, but the portion of “delayed” studies has remained consistent.

Investigation questions motives behind post-marketing studies

An investigation published by the BMJ today raises concern about the motives behind post-marketing studies of new treatments for diabetes and calls for better regulation to ensure "a proper balance" b...

Study Questions Post-Marketing Studies in India, Other Developing Nations

Post-marketing clinical trials in developing countries such as India often have more to do with increasing sales than serving a scientific purpose, according to a physician study in the British Medica...

Post marketing safety monitoring during a pandemic- Dr Hector Izurieta

  Flu: Post marketing safety monitoring during a pandemic- Dr Hector Izurieta Subscribe: http://www.youtube.com/user/vaccinenation  In light of the 2009 influenza pandemic, discussion into c...

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Safety profile of the Vero cell-derived Japanese encephalitis virus (JEV) vaccine IXIARO(®).

Japanese encephalitis (JE) is the most common cause for viral encephalitis in Asia and can be effectively prevented by vaccination. IXIARO(®) is a Vero cell-derived, inactivated JE virus vaccine whic...

Role of the Post-Marketing Authorisation Studies in Drug Risk Surveillance: Specifications and Methodologies.

Studies conducted after the marketing authorisation with the objective of identification, characterization or quantification of one or more risks (called PASS "Post-Authorisation Safety Studies"), hav...

Evaluation of the safety and efficacy of micafungin in Japanese patients with deep mycosis: a post-marketing survey report.

The safety and efficacy of micafungin were evaluated in a Japanese post-marketing survey involving 1,142 patients with deep mycosis caused by Candida or Aspergillus. The overall clinical response was...

Risk management of biosimilars in oncology: each medicine is a work in progress.

Drug licensing and drug safety monitoring for standard chemical entities have been established and are routinely used. These have resulted in a solid foundation of knowledge from which confident thera...

Safety evaluation of laninamivir octanoate hydrate through analysis of adverse events reported during early post-marketing phase vigilance.

Background: Abnormal behavior and delirium are common in children with influenza. While abnormal behavior and delirium are considered to be associated with influenza encephalopathy, an increased risk...

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