Off-Label, On-Target
نویسندگان
چکیده
منابع مشابه
Off-Label Promotion, On-Target Sales
For prescription drugs, demonstrated benefits define the parameters of acceptable risks. For example, liver toxicity may be acceptable in a drug approved for cancer, but unacceptable in a drug approved for acne. Government regulatory bodies review laboratory, animal, and human data to confirm that a drug has the claimed efficacy and safety prior to approving its release in the market for specif...
متن کاملReview Study: Intravenous Thrombolysis, Time Window, Dosage, and Off-Label
Despite the development of Intravenous thrombolysis with tissue Plasminogen Activator (IVtPA) guidelines in each affiliated stroke center, protocol violations may be observed in each hospital with IVtPA facilities. An extensive search of scientific electronic databases including PubMed, OVID, Index Medicus, Index Copernicus, Google, ISI, and Scopus was performed with keywords of Thrombolysis, O...
متن کامل[Challenges on off label medicine use].
p After the Second World War, the so-called pharmacological explosion took place, leading to major advances in the treatment of diseases that were once inevitably fatal or disabling. This pharmacological expansion contributed to the occurrence of catastrophic incidents, such as the phocomelia epidemic attributed to thalidomide. Since then, concerns about drug safety have contributed to the deve...
متن کاملOff-Label Drug Information
drug into interstate commerce unless the FDA has approved the drug and its label.2 A second provision prohibits manufacturers from introducing misbrandeddrugs into interstate commerce.2 Misbranding is considered to occur if drug labeling contains information that describes unapproved uses or is misleading or insufficient to support safe use for approved indications.2 Materials are considered pa...
متن کاملOff-label antibiotic preparation.
Dear Editor: Sterile ophthalmic injections with 2 antibiotics (ceftazidime and vancomycin) and 1 glucocorticoid (dexamethasone) are used at University Hospital of Geneva in some patients with infectious complications after intraocular surgeries. This is an off-label indication. They are administered as intravitre-ous injections and need to be prepared just before utilization , because the subst...
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ژورنال
عنوان ژورنال: JACC: Cardiovascular Interventions
سال: 2015
ISSN: 1936-8798
DOI: 10.1016/j.jcin.2015.09.011