[International approaches to the regulation of cell therapy products].

This article is a review of the main methods and approaches used in regulation of cell therapy products in the United States of America, Canada, European Union, Australia, Japan and South Korea. Intensive developments ofscientific and technological aspects in stem cell and tissue engineering have led to the wide use of human cells and tissues for the treatment of various diseases and injuries of organs and tissues. Drug regulatory agencies of different countries are working on implementation of a risk-based legal framework with some common features.

[Regulatory science: modern trends in science and education for pharmaceutical products].

This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation.

[Risk control strategy in the sphere of circulation of pharmaceuticals].

The article deals with classification of pharmaceutical risks and methodical approaches to their control in the system of governmental regulation of pharmaceuticals. According to the origin of risks and possibilities of their control, the authors distinguish "outer risks", not controlled by a consumer, and "inner risks", whose probability can be lowered by a consumer. Among the "outer risks" there are systematic risks, expressed by probability of adverse effects, and diversified risks, associated with pharmaceutical quality, practice of their administration and application, and partly--with insufficient knowledge of them.

Probiotics and mechanisms of their curative action.

Information about probiotics used for the correction of resident normal colon microflora and mechanism of their positive therapeutic actions are presented. Probiotics are drugs containing live microbes or substances of microbial origin that, when introduced by natural methods, are expected to confer beneficial physiologic, biochemical and immune effects to the host through the stabilization and optimization of functions of normal microflora. Probiotics containing the Bifidobacterium, Lactobacillus, Escherichia, Enterococcus, Asporogenic aerobe Bacillus and Saccharomyces boulardii microorganisms are characterized.

[Generation of platelet activating factor by neutrophils in patients with pulmonary tuberculosis].

PAF levels in native blood neutrophils before and after 1-hour incubation with killed BCG culture and in relevant incubation medium were measured in 44 patients with active pulmonary tuberculosis according to rabbit platelet aggregation. A control group consisted of 12 healthy volunteers. Neutrophil PAF concentrations in the patients were 6 times higher than those in the controls and caused a rise in plasma PAF levels.

[Platelet activating factor and pulmonary tuberculosis].

The content of platelet-activating factor (PAF) in plasma, blood, native neutrophils, in the same neutrophils after their incubation with a killed BGC culture and in the incubation medium was measured in 74 patients with various types of active pulmonary tuberculosis. Twelve healthy volunteers formed a control group. PAF was measured by the rabbit platelet aggregation technique.