Risk-based Methodology for Validation of Pharmaceutical Batch Processes.

Unlabelled: In January 2011, the U.S. Food and Drug Administration published new process validation guidance for pharmaceutical processes.

Lung function in silicosis.

In order to assess the effect of silicosis on lung function, 61 gold miners with radiological silicosis were compared with 61 controls. Each pair was matched for age, dust exposure, and smoking habits. A full range of lung function tests was performed, and with two exceptions the results showed no significant differences between the two groups.

Relevance of airflow obstruction and mucus hypersecretion to mortality.

A group of 2,065 gold miners surveyed between 1968 and 1970 was followed to 31 December 1986, at which date 859 were known to be dead. The relationship between airways obstruction and mucus hypersecretion to causes of mortality was analyzed. Airways obstruction was strongly related to mortality from chronic obstructive pulmonary disease (COPD), lung cancer, coronary heart disease and other causes.

Effects of personal, environmental and occupational factors on ischaemic heart disease in white miners in South Africa.

The objective of this study was to determine which personal, environmental and occupational factors were associated with risk of non-fatal ischaemic heart disease in a group of 3930 white underground miners born between 1916 and 1930. Evidence of previous myocardial infarction, based on their electrocardiograms and answers to the Rose questionnaire, was found in 179 men who were taken as the cases of interest. Because of difficulties in coding the occupational histories of all available miners, a representative sample of the remaining 'non-infarct' miners was drawn as a reference sample.