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W Stevens

Publications and source records attributed to W Stevens.

122 records · Page 7Linked to original sources

Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries.

There has been a significant increase in the number of clinical drug trials (particularly phase III) being conducted in developing countries for infectious diseases such as HIV, malaria, and tuberculosis. Laboratory results provided by medical testing laboratories in the region are critical to ensuring the safety of patients and the generation of good quality data. A number of well accepted Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines govern the conduct of clinical trials internationally. Good Clinical Practice guidelines remain too vague with respect to sample analysis to ensure practical implementation in these laboratories. In their strictest sense, Good Laboratory Practice guidelines refer to the analysis of samples from non-clinical studies. A specific set of minimum standards or requirements for practical implementation of clinical trial requirements in medical testing laboratories in the developing world is urgently required.

Benchmarking↗

An unusual case of generalized oedema.

We present the case of a 66-year-old woman with generalized oedema and pain in the four limbs. Physical examination revealed a diffuse, painful, partly pitting, oedema of forearms, hands, lower legs and feet. There were no signs of synovitis. Laboratory investigation was non relevant, except for mild eosinophilia, which normalized subsequently. Cardiac, nephrological and venous disturbances were excluded. More uncommon disorders, such as eosinophilic fasciitis, early stage of scleroderma and polymyositis were considered. MRI scanning of the right forearm revealed an increased signal intensity in the superficial muscle fibers and thickening of the fascia (figure 1). Subsequently a full thickness biopsy of the musculus flexor digitorum superficialis was performed, revealing an inflammatory infiltration of lymphocytes and eosinophils, localized in the fascia. There was no necrosis of muscle fibers. No signs of scleroderma were found. The biopsy confirmed the diagnosis of eosinophilic fasciitis. Clinical and MRI findings suggested an early stage of disease and the patient was treated with low-dose corticosteroids.

Adrenal Cortex Hormones↗