Compassionate use of drugs and medical devices in the United States, the European Union and Japan.

Compassionate use, also called expanded access, provides an important pathway for patients with life-threatening conditions to gain access to unapproved investigational drugs, biologics and medical devices. Although the United States (US) and the countries of the Europe Union (EU) have mechanisms that are associated with the use of unapproved products, as of May 2015 there was no such mechanism in Japan. Instead, unapproved products are used under a physician's discretion in conjunction with the Japan Medical Practitioners' Act or Advanced Medical Care B.

Re-examination of regulatory opinions in Europe: possible contribution for the approval of the first gene therapy product Glybera.

The first commercially approved human gene therapy in the Western world is Glybera (alipogene tiparvovec), which is an adenoassociated viral vector encoding the lipoprotein lipase gene. Glybera was recommended for marketing authorization by the European Medicines Agency in 2012. The European Medicines Agency had only ever reviewed three marketing authorization applications for gene therapy medicinal products.

Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan.

Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European Union (EU), and Japan. In this study, the definition, legislation, and approval system of these products were surveyed.

The regulation of allogeneic human cells and tissue products as biomaterials.

The current definition of biomaterials differs vastly from it of just a decade ago. According to advancing technologies, it encompasses unpredictable materials such as engineered human cells and tissue. These biomaterials also have to be approved to use in health care business by regulatory authority, which are defined as drug, medical device, or biologics in the regulation.

Analysis of heavy metal pollution in soil using transversely excited atmospheric CO2 laser-induced plasma by trapping the soil in microstructured holes on metal subtargets.

A unique technique for direct analysis of soil samples utilizing a special advantage of a transversely excited atmospheric (TEA) CO(2) laser-induced plasma generated at atmospheric pressure on a metal target has been developed. In this technique, a metal subtarget, such as nickel plate, structured with intentional microholes on its surface, each with dimensions of around 100 microm in diameter and depth, was used to selectively trap small sized soil particles by immersing the metal plate subtarget into the polluted soil sample. The trapped small soil particles on the metal subtarget were irradiated by a TEA CO(2) laser (10.

Carbon analysis for inspecting carbonation of concrete using a TEA CO2 laser-induced plasma.

It has been demonstrated that a spectrochemical analysis of carbon using the laser plasma method can be successfully applied to inspect the carbonation of concrete by detecting carbon produced in aged concrete by a chemical reaction of Ca(OH)2 with CO2 gas in environmental air, turning into CaCO3, which induces degradation of the quality of building concrete. A comparative study has been made using a TEA CO2 laser (500-1000 mJ) and a Q-switched Nd-YAG laser (50-200 mJ) to search for the optimum conditions for carbon analysis, proving the advantage of the TEA CO2 laser for this purpose. Also, it was clarified that laser irradiation with suitable defocusing conditions is a crucial point for obtaining high sensitivity in the detection of carbon.

Measurement of concrete strength using the emission intensity ratio between Ca(II) 396.8 nm and Ca(I) 422.6 nm in a Nd:YAG laser-induced plasma.

An experiment to investigate the potential of a laser-induced plasma method for determining concrete compressive strength was conducted by focusing a Nd:YAG laser on concrete samples with different degrees of compressive strength. This technique was developed in light of the role of the shock wave in the generation of a laser-induced plasma. It was found that the speed of the shock front depends on the hardness of the sample.