The arrival of drug-eluting stents raises important questions about preclinical evaluation of devices and the optimal means of predicting clinical safety and efficacy. The Interventional, Regulatory, Commercial, and Scientific communities have all asked for assistance in defining criteria for device evaluation. This document is an integrated view of requirements for evaluating drug-eluting sten...

The arrival of drug-eluting stents raises important questions about preclinical evaluation of devices and the optimal means of predicting clinical safety and efficacy. The Interventional, Regulatory, Commercial, and Scientific communities have all asked for assistance in defining criteria for device evaluation. This document is an integrated view of requirements for evaluating drug-eluting sten...

Author Affiliation: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, Silver Spring, Maryland

Toxicogenomics focuses on assessing the safety of compounds using gene expression profiles. Gene expression signatures from large toxicogenomics databases are expected to perform better than small databases in identifying biomarkers for the prediction and evaluation of drug safety based on a compound's toxicological mechanisms in animal target organs. Over the past 10 years, the Japanese Toxico...

background: more than 80% of patients with hematologic  malignancies will develop fever during more than one chemotherapy cycle combined with neutropenia. we aim to evaluate empiric antibiotic strategies in febrile neutropenic (fn) cancer patients. methods: this is a concurrent study performed in the “shahid ghazi” teaching hospital, hematology-oncology center of tabriz, iran during the period ...

in order to investigate the effect of pharmacist intervention on vancomycin use, this study was performed on all patients receiving vancomycin in the intensive care unit (icu) and hematology-oncology ward of taleghani educational hospital in tehran, iran. vancomycin use was assessed during a pre- and post-intervention period in accordance with the center of disease control and prevention (cdc) ...

Hypertension increases in prevalence with advancing age and is a major risk factor for the development of cardiovascular disease in elderly patients. However, the presence of coexisting illness, altered drug metabolism, enhanced susceptibility to drug side effects, and physiologic changes such as reduced plasma volume and lower plasma renin levels make treatment of hypertension in elderly patie...

Since 2011, pharmaceutical companies in Japan have been required to issue two types of documents regarding severe adverse drug reactions reported post-marketing, namely the Rapid Safety Communication Materials for Patients and Related Materials. However, adequacy these has not yet systematically assessed. The aim this study was evaluate materials. Communications were obtained from Pharmaceutica...

Current preclinical safety evaluation programs use a combination of computational methods, mechanistic in vitro screening and - primarily - in vivo experimentation to predict human toxicity. The rapid transition of pharmaceutical R&D into electronic R&D (e-R&D) makes it imperative that predictive safety testing also develops into an information-rich, knowledge-based process in the near future. ...