Decisions regarding investigational new drug applications for testing of all biologicals to be used in humans, including those designed to prevent or treat cancers, must be considered in terms of benefit/risk ratios. In order for a regulatory organization to make the appropriate decision regarding the testing of new biologicals in humans, it must have an extremely broad dialog within the critic...

The use of drugs during pregnancy and breast-feeding is a long-lasting debate among scientists. Many of them support the view that the risks are minimal, since the anomalies in fetuses due to chemical compounds are approximately 1%, while others argue that the effects of drug delivery in this special period of life has largely unknown delayed consequences. In clinical practice the dilemma is to...

During the past five decades recreational alpine skiing has become increasingly safer. The numerous annual media reports on ski injuries have to be interpreted on the basis of the tremendous numbers of skiers. These favourable changes seem primarily be due to the introduction of short carving skis, more rigid and comfortable ski boots, the use of protective gear like helmets, and the optimized ...

BACKGROUND In Russia, the incidence of melanoma is increasing steadily. The approved standard of specialized medical care for melanoma of the skin defined the range of drugs, recommended for the provision of quality health care. However, it appears that the most effective innovative and safe medicines are at the same time the most expensive drugs. The most important is the assessment of drug us...