Records controlled dmgs

The activity of ivermectin against the filarial parasite Dirofilaria immitis in dogs suggested a possible role for the control of filarial parasites of humans (20). It has been extensively tested in human onchocerciasis and is now considered to be the dmg of choice. In a single yearly oral dose, it suppresses microfilariae in the skin and eyes and, in most cases, prevents the progression of the disease to blindness. Table 4 shows the results of a 30-patient double-blind study recorded over one year. 

The review and approval of production and control records by the quality control unit shall extend to those records not directly related to the manufacture, processing, packing, or holding of a specihc batch of large volume parenteral dmg product but which have a bearing on the quality of batches being produced. Such indirectly related records shall include ... 

Dr. J. F. J. Cade, an Australian psychiatrist, first reported on the beneficial use of a lithium compound for a psychiatric disorder, namely, manic behavior in 1949. The early human trials were undertaken after initial experiments on rats, which became quite lethargic after treatment with lithium urate. Fairly large doses were required for treating manic behavior and its use for this disorder has been displaced by organic drugs that carry less risk. His report, however, led to its current nse as a treatment for bipolar affective disorder (also known as manic-depressive disorder). Its use in the United States was curtailed for a decade and a half by the US. Food and Dmg Administration (FDA), which based its decision on incidental poisonings due to overuse of a lithium-based table salt substitute, despite a safe record of controlled psychiatric apphcations in Europe. It has been estimated that by 1985... 

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