Clinical Pharmacy Articles
EDC, RDE, OCR: We speak the same languageor do we?
Readers share their experiences
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Chlamydia pneumoniae and Atherosclerosis: Critical Assessment of Diagnostic
A number of studies have found that inflammation of the vessel wall plays an essential role in both the initiation and progression of atherosclerosis and erosion and fissure and the eventual rupture of plaques. Chlamydia pneumoniae is one of the infectious agents that have been investigated as possible causes of this inflammation. Initial studies of the association of C. pneumoniae and cardiovascular disease (CVD) were seroepidemiologic, and these were followed by studies in which the organism was identified in vascular tissue from patients with CVD by electron microscopy, PCR and immunocytochemical staining (ICC). C. pneumoniae has also been isolated by culture from vascular tissue in a small number patients. However, no single serologic, PCR, or ICC assay has been used consistently across all studies. The assays used are also not standardized. Recent studies of serologic and PCR assays for diagnosis of C.
Changes in Psychoactive Drug Prescribing Over Four Years in 30 Nursing Facilities
Alvin Sandberg
Clinical Note Objective: To determine what changes, if any, had occurred in the use of the antipsychotic, antidepressant, anxiolytic, and sedative/hypnotic classes of psychoactive drugs in comparison to the results of a study conducted in the same nursing facilities four years earlier.
Study Population: Three thousand, nine hundred and eighty-three residents of 30 nursing facilities in seven states.
Practice Description: Nineteen nursing facilities in eastern Tennessee and 11 additional nursing facilities geographically dispersed throughout the eastern United States.
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Aetiology and pathology oftype 2diabetesmellitus
iabetes mellitus (DM) is a group of metabolic disorders characterised by raised blood sugar due to defects in insulin secretion, action or both.The chronic hyperglycaemia of DM is associated with longterm damage, dysfunction and failure of organs, such as the eyes, kidneys, nerves, blood vessels and heart. The first organised attempt to develop diagnostic criteria was probably carried out by the National Diabetes Data Group in 1979.1 Later, in 1985, the diagnostic criteria were modified by the World Health Organisation (WHO).2 These criteria were followed until the recent modification recommended by an expert committee(Panel 1).3
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Microchip Electrophoresis
Microchip electrophoresis has immense potential for clinical diagnostics.
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Biomarkers and Surrogate Endpoints in Clinical Drug Development
Both large and small pharmaceutical companies have learned that the value of their development candidates increases once clinical research has demonstrated their proof of concept. Sponsor companies face the challenge of moving new blockbuster drugs to market as rapidly as possible.
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The 11-Day Week
Arbitrarily scheduled meetings eat away at valuable time otherwise spent actually getting things done.
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More Trouble Over EU Clinical Trials Rules
European organizations express their concerns over the implications of the EU guidances issued in response to the 2001 directive.
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Ethics, Kids, and Sex
As the debate on clinical research policy continues, FDA is setting standards for pediatric studies and encouraging more sex-specific analysis of clinical data.
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