[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. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

Evaluation of brilliance and visibility of fluorescence and chemiluminescence solution for training of preparing injections.

Personnel who prepare and administer chemotherapeutic agents have been reported to develop untoward effects. The use of appropriate techniques for preparing these agents is encouraged, and educational training systems that involve the use of a fluorescent or chemiluminescence reagent as placebos have been established to minimize potential exposure to these agents. However, the optimum conditions for the use and visibility of these placebos remain obscure. In this study, our results indicated that the fluorescence intensity of fluorescent reagent decreased when it was used at a concentration greater than 0.01%. Because drops created due to splashes and leaks are extremely small and easily evaporate, it is possible that the fluorescence resulting from such drops readily disappears despite using an anti-evaporation reagent. We also developed a method to evaluate the visibility of the small drop; using this method, we determined the distance at which the drop present on the pin could be seen by the observer. The distance at which the drop was clearly recognized as a pinpoint by using the fluorescence method was almost comparable to that for the chemiluminescence method. In the chemiluminescence method, the drop on the pin was faintly visible as a slightly bright area because of low background when observed at a certain distance that was much greater than that at which the drop was clearly visible; however, such an area was not observed in the fluorescence method. The results of our study will help in the selection of a training method depending on the situation.

Avances en la enseñanza de posgrado en la actividad farmacéutica y alimentaria / Advances in the graduate education in the pharmaceutic and food areas

El Instituto de Farmacia y Alimentos (IFAL) de la Universidad de La Habana (UH) ha implementado su cuarto nivel de enseñanza en las áreas de Ciencias Farmacéuticas y Ciencias de los Alimentos, con un enfoque integrador y en estrecho vínculo con los organismos e instituciones de estas ramas; también ha proyectado un conjunto de actividades que han conformado el Sistema de Posgrado del IFAL y lo han fortalecido. Para la evaluación de este sistema se realizaron encuestas a los estudiantes, entrevistas a los dirigentes de las instituciones de procedencia de los posgraduados y se consideraron los procesos de evaluación interna y externa; además se tomaron las medidas pertinentes para elevar la calidad de las actividades que se desarrollan. El análisis de los resultados evidencia el avance y la calidad de las diferentes actividades que se ejecutan, con reconocimiento a la excelencia del claustro de profesores y tutores; se destaca la pertinencia e impacto social, reconocido por las instituciones y organismos a los cuales pertenecen los estudiantes