Drug Safety/Pharmacovigilance Featured Articles
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How To Use Pharmacovigilance Methods To Detect Safety Issues
12/16/2015
According to MarketsandMarkets, the global pharmacovigilance market is expected to reach a value of 154.1 million in 2019 . Many serious safety issues can be detected early with application of pharmacovigilance methods, thereby enabling pharmaceutical companies to obtain marketing authorizations / approvals and providing patient access to important therapies.
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Managing the Long-Term Medical Expenses of Adverse Drug Events
12/10/2015
Pharmaceutical developers purposefully enroll subjects who are relatively homogenous in pre-approval clinical trials. They do this to help obtain clear statistical descriptions regarding a compound’s efficacy. Safety profiles, however, can differ greatly between such homogenous pre-approval patients and the heterogeneous population of real world patients.
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Do You Know If Concomitant Medications Are Impacting Your Trial?
10/20/2015
There are a lot of things that can sink your clinical trial. Low patient recruitment, poor data, or issues with safety or efficacy, for instance. But what shouldn’t be a problem are issues arising with concomitant medications (two or more drugs used or given at or almost at the same time.) Unfortunately, many sponsor companies currently do not see concomitant medication tracking as a topic that is particularly important.
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Should A Clinical Mastermind Run The FDA?
9/23/2015
We all know that a primary driver of the high cost of drug development is clinical trials. The process is not only costly, but lengthy and difficult. And even once you complete the four phases and submit your data to the FDA, there is no guarantee the drug will be approved. All this might make you wonder: Could the drug development process be made easier if we had a clinical researcher at the helm of the FDA? You may not need to wonder much longer.
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The Ethical Dilemma Of Patient-Funded Trials
8/17/2015
Clinical trials are the costliest aspect of drug development. They can also be the most time consuming component of the discovery process. In those instances where the treatment is for a rare disease, patient funding could pick up the tab for research that pharma companies and governments are not willing to support. However, many would argue that pharma companies perform a lot of research and scientific rigor when determining which molecules are worthy of entering the clinical trial process. In a patient-funded model, desperate patients, and the size of their bank account, could be making those decisions.
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Considerations For The Ethical Use Of Patients In Clinical Trials
8/6/2015
Linda Strause, PhD, is passionate about the ethical treatment of patients. Her interest in the ethics surrounding human subjects stems out of her work with the San Diego Hospice. She ultimately served as the chair of the San Diego Hospice and Institute of Palliative Medicine IRB for 15 years. While that experience provided her with a close look into the treatment of patients, her interest in the subject quickly became more personal when she learned her husband had developed inoperable brain cancer.
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New EU Regulation Set To Drive Clinical Trial Harmonization
7/28/2015
Sponsor companies conducting clinical trials in the European Union (EU) are currently regulated by EU Directive 2001/20/EC, which provides guidance on clinical trial applications and conduct. Unfortunately, Directives always have to be transposed into National law. By transposing, different countries interpret Directives in slightly different ways. Every country has its own national legislation, resulting in different submission requirements, timelines, classifications, and safety reporting. The result of this lack of harmonization is a complicated and expensive trial process.
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Are Absolute Cell Counts Essential In Drug Discovery?
5/11/2015
While absolute cell counts have been a part of diagnosis for a long time, what is new are absolute count relevance to drug discovery and development.
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Signal Management In Drug And Biosimilars Development
5/7/2015
Signal management in drug development has been ongoing, evolving, and improving for many years. For the European Medicines Agency (EMA), Food and Drug Administration (FDA) and other regulatory bodies immunogenicity is a major area of safety concern for biosimilars as well as for peptide, protein, and drug therapeutics, all of which have the potential to trigger some level of antibody response.
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How Do I Get My Compound Into Phase I?
4/2/2014
The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert