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Silver Spring, MD, United States

Stockbridge M.D.,University of Maryland University College | Taylor K.,White Oak Research Center
Therapeutic Innovation and Regulatory Science | Year: 2015

There is an increased risk of medication error and harm to a patient whenever 2 or more drug product names appear alike in sound, look, or meaning. Any ambiguity of the proprietary name (“trade” or “brand” name) of a drug product can lead to errors in ordering, dispensing, or administering medication. A drug’s name is a critical identifier, and correct product identification is important to the responsible administration of medicine. This article describes a series of tools created for regulatory reviewers to enhance the review of proprietary names under current federal regulations, with the goal of encouraging further innovation toward the goal of medication safety. These tools include measures of orthographic, phonetic, and semantic similarities and are designed be used together with the existing computerized measures of similarity. It is the hope that highlighting the importance of medication error reporting for the safety review process will further encourage health care professionals to provide adequate and detailed reporting regarding medication errors, which will lead to improvements in the overall safety review process. © 2015, © The Author(s) 2015.

Senior J.R.,White Oak Research Center
Clinical Pharmacology and Therapeutics | Year: 2012

Assay of the serum activity of the enzyme alanine aminotransferase (ALT) has become the primary screening tool for detecting acute liver injury. But what does an elevated value mean Not what it is too often mistakenly believed to indicate. It is not a test of liver function. It does not necessarily predict worse effects to come (in a given person). It is not a valid measure of severity of liver injury or dysfunction. It is too unspecific to be reliable in screening for relatively rare effects on the liver. Although these are substantial limitations, ALT is a very useful biomarker if understood and used properly. It is important to consider how and why these erroneous concepts came to have such wide acceptance, and how elevations of ALT activity for evaluating patients and subjects under study might be interpreted better. © 2012 American Society for Clinical Pharmacology and Therapeutics.

Sheng-Fowler L.,OVRR | Cai F.,OVRR | Cai F.,U.S. National Cancer Institute | Fu H.,OVRR | And 12 more authors.
International Journal of Biological Sciences | Year: 2010

Vaccines contain residual DNA derived from the cells used to produce them. As part of our investigation to assess the risk of this cellular DNA, we are developing a quantitative in vivo assay to assess the oncogenicity of DNA. In an earlier study, we had generated expression plasmids for two oncogenes - human activated T24-H-ras and murine c-myc - and had shown that these two plasmids, pMSV-T24-H-ras and pMSV-c-myc, could act in concert to induce tumors in mice, although the efficiency was low. In this study, we took two approaches to increase the oncogenic efficiency: 1) both oncogene-expression cassettes were placed on the same plasmid; 2) transfection facilitators, which increase DNA uptake and expression in vitro, were tested. The dual-expression plasmid, pMSV-T24-H-ras/MSV-c-myc, is about 20-fold more efficient at tumor induction in newborn NIH Swiss mice than the separate expression plasmids, with tumors being induced with 1 μg of the dual-expression plasmid DNA. However, none of the transfection facilitators tested increased the efficiency of tumor induction. Based on these data, the dual-expression plasmid pMSV-T24-H-ras/MSV-c-myc will be used as the positive control to develop a sensitive and quantitative animal assay that can be used to assess the oncogenic activity of DNA. © Ivyspring International Publisher.

Cohen E.,White Oak Research Center | Agrawal A.,White Oak Research Center | Connors M.,University of Maryland University College | Hansen B.,White Oak Research Center | And 2 more authors.
Journal of Neural Engineering | Year: 2011

We have developed a novel method to study the effects of electrical stimulation of the local retina directly under an epiretinal stimulus electrode in real time. Using optical coherence tomography (OCT) and a superfused retinal eyecup preparation, we obtained high-resolution images of the rabbit retina directly under an optically transparent saline-filled fluoropolymer stimulation tube electrode. During OCT imaging, 50 Hz trains of biphasic current pulses 1 ms/phase (23-749 νC cm -2 ph -1) were applied to the retinal surface for 5 min. After imaging, the stimulated regions were stained with the dye propidium iodide (PI) to reveal cytotoxic damage. Pulse train stimulation at 44-133 νC cm -2 ph -1 had little effect on the retina; however, trains ≥442 νC cm -2 ph -1 caused increases in the reflectance of the inner plexiform layer (IPL) and edema. The damage seen in retinal OCT images matched the pattern observed in histological sections, and in the PI staining. With pulse trains ≥442 νC cm -2 ph -1, rapid increases in the reflectivity of the IPL could be observed under the stimulus electrode. Below the electrode, we observed a ring-like pattern of retinal detachment in the subretinal space. The OCT imaging method may be useful for analyzing overstimulation of neuronal tissue by electrodes in many brain regions. © 2011 IOP Publishing Ltd.

Wu H.,White Oak Research Center | Khan M.,White Oak Research Center
Sustainable Packaging Symposium 2012 | Year: 2012

As an emerging technology, THz spectroscopy has gained increasing attention in the pharmaceutical area during the last decade. This attention is due to the fact that (1) it provides a promising alternative approach for in-depth understanding of both intermolecular interaction among pharmaceutical molecules and pharmaceutical product quality attributes; (2) it provides a promising alternative approach for enhanced process understanding of certain pharmaceutical manufacturing processes; and (3) the FDA pharmaceutical quality initiatives, most noticeably, the Process Analytical Technology (PAT) initiative. In this work, the current status and progress made so far on using THz spectroscopy for pharmaceutical development and pharmaceutical PAT applications, including FDA-NIST collaboration on THz spectroscopy pharmaceutical characterization and PAT applications, are discussed. In the spirit of demonstrating the utility of first principles modeling approach for addressing model validation challenge and reducing unnecessary model validation "burden" for facilitating THz pharmaceutical PAT applications, two scientific case studies are created and discussed. Furthermore, other technical challenges and opportunities associated with adapting THz spectroscopy as a pharmaceutical PAT tool are highlighted.

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