• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.159-184
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• 2021

The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

• Journal of Bio-Environment Control
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• v.21 no.4
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• pp.419-427
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• 2012

This study was carried out to investigate the effect of two shading methods, shading agent spray on the glasshouse and internal shading screen treatment, on the growth and fruit quality of paprika (Capsicum annuum L. 'Cupra' and 'Coletti') in summer season cultivation. In the shading agent treatment, a commercial shading agent diluted with water at a ratio of 1 : 4 was sprayed on the roof of a glasshouse. In the internal shading screen treatment, a 10~20% shaded screen was used during the day time when the sun radiation was greater than $700W{\cdot}m^{-2}$. Compared to the unshaded control, photosynthetic photon flux density (PPFD) decreased in the greenhouse in the shading agent (SA) and shading screen (SS) treatments by 20% and 30%, respectively. Lower air temperatures and higher relative humidities were observed in the SA than in both the control and the SS treatment. Time to reach the break point of humidity deficit $8g{\cdot}m^{-3}$ was 2 hours late in the SA than in both the control and the SS treatment. Compared to control, both the SA and the SS treatments showed lower instantaneous temperatures of leaf, fruit, and flower by $2^{\circ}C$, $5^{\circ}C$ and $3^{\circ}C$, respectively. There were no differences in number of branches, stem diameter, and leaf size among treatments although both shading treatments promoted plant height in both cultivars. Botrytis infection ratio declined with the SA treatment by 14.7% in 'Cupra' and 22.1% in 'Coletti' as compared to that in the control. Shading increased fruit size in both cultivars, whereas no differences were observed in the number of locules and thickness of fruit tissue among treatments. Shading treatment increased mean fruit weight by a range of 10 to 15 g per fruit, while it decreased soluble solids contents as compared to that in the control. Similar Hunter values were observed among treatments, while fruit firmness increased slightly in shading treatments. Compared to the control, shading treatments improved marketable fruits by 11.7~22.6% and increased the number of fruits per plant by 4~9.2 in both 'Cupra' and 'Coletti'. The results of this study indicate that shading agent application on the roof of glasshouse would be one of the most effective options to reduce heat stress imposed on the paprika crop in summer cultivation, resulting in improved crop growth and fruit yield.