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Despite legislation incentivizing and requiring drug companies to conduct pediatric clinical trials, there still is a 9-year delay in drug approval for pediatric labeling after the initial adult drug approval. The aim of this study was to review the experience of the US Food and Drug Administration (FDA) with combined pediatric and adult trials as a means for expediting pediatric approval and labeling. Combined pediatric and adult trials submitted to the FDA from 2012 to 2018 were reviewed. Only the publicly available labels and reviews were utilized for this analysis. Combined trials were identified for 72 products, with a total of 156 combined adult and pediatric trials. The therapeutic areas with the largest number of combined trials were in pulmonology for products reviewed under the Best Pharmaceuticals for Children Act (BPCA) and/or the Pediatric Research Equity Act (PREA), and hematology reviewed under the Orphan Drug Act (ODA). All drugs that utilized combined pediatric and adult clinical trials were approved simultaneously for both the adults and that part of the pediatric population. A separate pediatric subgroup efficacy analysis was reported in 57% and 48% of products under BPCA/PREA and the ODA, respectively, with a separate safety analysis in 48% and 38% of these products. When considering both BPCA/PREA and orphan drug studies, all the combined pediatric and adult trials allowed concurrent approval and labeling for part of the pediatric population at the time of the adult approval.

A treatment gap exists for pediatric patients with renal impairment. Alterations in renal clearance and metabolism of drugs render standard dosage regimens inappropriate and may lead to drug toxicity, but these studies are not routinely conducted during drug development. The objective of this study was to examine the clinical evidence behind current renal impairment dosage recommendations for pediatric patients in a standard pediatric dosing handbook. The sources of recommendations and comparisons included the pediatric dosing handbook (Lexicomp), the U.S. Food and Drug Administration-approved manufacturer’s labels, and published studies in the literature. One hundred twenty-six drugs in Lexicomp had pediatric renal dosing recommendations. Only 14% (18 of 126) of Lexicomp pediatric renal dosing recommendations referenced a pediatric clinical study, and 15% of manufacturer’s labels (19 of 126) described specific dosing regimens for renally impaired pediatric patients. Forty-two products had published information on pediatric renal dosing, but 19 (45%) were case studies. When pediatric clinical studies were not referenced in Lexicomp, the renal dosing recommendations followed the adult and pediatric dosing recommendations on the manufacturer’s label. Clinical evidence in pediatric patients does not exist for most renal dosing recommendations in a widely used pediatric dosing handbook, and the adult renal dosing recommendations from the manufacturer’s label are currently the primary source of pediatric renal dosing information.

Water quality deterioration due to outdoor loading of livestock manure requires efficient management of outside manure piles (OMPs). This study was designed to investigate OMPs using unmanned aerial vehicles (UAVs) for efficient management of non-point source pollution in agricultural areas. A UAV was used to acquire image data, and the distribution and cover installation status of OMPs were identified through ortho-images, the volumes of OMP were calculated using digital surface model (DSM). UAV- and terrestrial laser scanning (TLS)-derived DSMs were compared for identifying the accuracy of calculated volumes. The average volume accuracy was 92.45%. From April to October, excluding July, the monthly average volumes of OMPs in the study site ranged from 64.89 m3 to 149.69 m3. Among the 28 OMPs investigated, 18 were located near streams or agricultural waterways. Establishing priority management areas among the OMP sites distributed in a basin is possible using spatial analysis, and it is expected that the application of UAV technology will contribute to the efficient management of OMPs and other non-point source pollutants.

Since outdoor compost piles (OCPs) contain large amounts of nitrogen and phosphorus, they act as a major pollutant that deteriorates water quality, such as eutrophication and green algae, when the OCPs enter the river during rainfall. In South Korea, OCPs are frequently used, but there is a limitation that a lot of manpower and budget are consumed to investigate the current situation, so it is necessary to efficiently investigate the OCPs. This study compared the accuracy of various machine learning techniques for the efficient detection and management of outdoor compost piles (OCPs), a non-point pollution source in agricultural areas in South Korea, using unmanned aerial vehicle (UAV) images. RGB, multispectral, and thermal infrared UAV images were taken in August and October 2019. Additionally, vegetation indices (NDVI, NDRE, ENDVI, and GNDVI) and surface temperature were also considered. Four machine learning techniques, including support vector machine (SVM), decision tree (DT), random forest (RF), and k-NN, were implemented, and the machine learning technique with the highest accuracy was identified by adjusting several variables. The accuracy of all machine learning techniques was very high, reaching values of up to 0.96. Particularly, the accuracy of the RF method with the number of estimators set to 10 was highest, reaching 0.989 in August and 0.987 in October. The proposed method allows for the prediction of OCP location and area over large regions, thereby foregoing the need for OCP field measurements. Therefore, our findings provide highly useful data for the improvement of OCP management strategies and water quality.

Pediatric safety evaluations are an essential part of a pediatric drug development program. Communication of the results of these safety evaluations is primarily accomplished by labeling of the drug either during the initial pediatric drug development program, or during the postmarketing period after drug approval for pediatric patients. During drug development, the dose-adverse drug event (ADE) relationship is an important part of the evaluation, but a consideration for pediatric ADEs that are unrelated to drug dosage must be maintained. Examples of dose-related and non-dose-related ADEs are presented. The failure to label a product for pediatric use has been safety related for a number of development programs. The US Food and Drug Administration's Pediatric Advisory Committee is a primary source of the pediatric postmarketing safety review and has been associated with a number of labeling changes through its ongoing review process. Pediatric drug safety remains a critical part of the assessment of dose-effect relationship in the pediatric patient population during the drug development and postmarketing surveillance process.

The Orphan Drug Act (ODA) of 1983 was enacted to provide financial incentives to drug sponsors to develop therapies for rare diseases. Although this act increased the number of orphan products approved, there are still a limited number of products available for the pediatric population because orphan drug products are exempt from the Pediatric Research Equity Act. The objectives of this study were (i) to evaluate the pediatric orphan drug studies submitted to the US Food and Drug Administration (FDA) in the period of 2007-2018 and (ii) to examine whether orphan drug products were fully labeled with a pediatric indication in infants and neonates. Out of the 468 indications evaluated, 171 (37%) were FDA-labeled for use in the pediatric population. Labeling for the 12 to

Dosing is a critical aspect of drug development in pediatrics that has led to trial failures and the inability to label the drug for pediatric use by the US Food and Drug Administration. Developing a structured approach for pediatric dose selection requires knowledge of the current approaches and their success or failure. This study describes the current experience with pediatric dosing methods from 2012 to 2020 and had 2 primary objectives: (1) to identify how the initial pediatric dose was selected and (2) to identify the pivotal dosing strategy used to identify the initially selected dose for safety and efficacy for pediatric clinical trials. Through September 2020, a total of 275 pediatric drug development programs were characterized for initial and pivotal dosing strategies. The success rate for labeling for pediatric use was 76.4%. The most common initial dosing strategy was previous experience with the product, followed by allometric scaling and exposure matching with adults. The most common pivotal dosing strategy was titration to target response in 33% of programs, with the second and third most common being pharmacokinetic/pharmacodynamic studies (30%) and exposure matching (20%), respectively. Additionally, about one-half of pediatric programs incorporated model-informed drug development. The emergence of titration to target response may signal a shift toward precision medicine in pediatric patients. Future work in pediatric drug dose selection should move toward the development of a structured pediatric dose selection approach.

The accuracy of land surface temperatures (LSTs) acquired by an unmanned aerial vehicle (UAV) was verified by comparison with in-situ LSTs of various land cover materials at the Changwon National University Campus, Changwon City, South Korea. UAV imaging and in-situ measurements were performed on 31 July and 2 August 2019. During the in-situ measurements, LST was measured at 160 points using an infrared thermometer. The linear regression model between the UAV and in-situ measurements exhibited a very high correlation on both days, with R2 values greater than 0.7004. The root mean square error (RMSE), however, was 4.030 °C on 31 July and 5.446 °C on 2 August and it also varied depending on the land cover type. These results may depend on various factors, such as the field of view and performance of the TIR (Thermal infrared radiance) camera, as well as the weather and atmospheric conditions. Accurately diagnosing the thermal characteristics of urban areas based on the spatial elements can be used to accurately analyze the thermal characteristics of urban areas and to make effective policy decisions. Techniques for verifying and improving the accuracy of UAV TIR LST data for various land cover materials are required to enable precise investigation of the thermal characteristics of urban areas.

The aim was to identify microclimate characteristics in relation to ground cover in green areas and the reflectivity of building coating materials. Furthermore, microclimate modeling of temperatures was conducted using ENVI-met, to analyze the effects of improved thermal environments based on increased green areas and increased reflectivity of exterior coatings. The accuracy of ENVI-met was validated through comparisons with field temperature measurements. The RMSE deviation of the predicted and actual field temperature values was 3–6°C; however, the explanatory power was as high as 60%. ENVI-met was performed for commercial and single residential areas that have high densities of artificial cover materials, before and after changes related to development of green areas and to increase in the reflectivity of coating materials. The results indicated that both areas exhibited distinct temperature reductions due to the creation of green spaces. When the reflectivity of the coating material was increased, a temperature increase was observed in all land-use types. Therefore, in order to improve the thermal environment of complex urban areas, it is necessary to improve green-area development and to use high-reflectivity ground and building cover materials, while taking into account the spatial characteristics of land-use types and their surrounding areas.

Long-term monitoring was performed between December 2017 and November 2018 on cool roof–applied building (CR) and non-cool roof–applied building (NCR). The study was conducted in Changown city South Korea, which has a humid subtropical climate, to identify the temperature reduction effect on different building layers (rooftop surface, ceiling surface and air, and room air). With respect to the temperature reduction effect by layer according to the application of a cool roof (NCR−CR), the rooftop surface temperature showed an increasing temperature reduction effect with increase in air temperature. Ceiling surface and air temperatures showed similar temperature reduction effects in summer and winter, whereas room air temperature showed greater temperature reduction in the winter than in summer. This finding was contrary to the results for room air temperature in the winter reported in previous studies. In conclusion, the present study confirmed that applying cool roofs on buildings located in humid subtropical climates has more pronounced effects in terms of reduced indoor temperature (ceiling surface, ceiling air, and room air) in winter than in summer. The long-term measurement results produced in this study may be used as basic data for establishing criteria for cool roof performance and product selection in South Korea.

This research measures and compares on-site net radiation energy, air temperature, wind speed, and surface temperature considering various spatial characteristics with a focus on land use types in urban areas in Changwon, Southern Gyeongsangnam-do, to analyze the accuracy of an ENVI-met model, which is an analysis program of microclimate. The on-site measurement was performed for three days in a mobile measurement: two days during the daytime and one day during the nighttime. The analysis using the ENVI-met model was also performed in the same time zone as the on-site measurement. The results indicated that the ENVI-met model showed higher net radiation than the on-site measurement by approximately during the daytime whereas the latter showed higher net radiation energy by approximately during the nighttime. The temperature was found to be much higher by approximately in the on-site measurement during both the daytime and nighttime. The on-site measurement also showed higher surface temperature than the ENVI-met by approximately . In terms of the wind speed, there was a significant difference between the results of the ENVI-met model and on-site measurement. As for the correlation between the results of the ENVI-met model and on-site measurement, the temperature showed significantly high correlation whereas the correlations for the net radiation energy, surface temperature, and wind speed were very low. These results appear to be affected by excessive or under estimation of solar and terrestrial radiation and climatic conditions of the surrounding areas and characteristics of land cover. Hence, these factors should be considered when applying these findings in urban and environment planning for improving the microclimate in urban areas.

Spatiotemporal air and land surface temperature (LST) characteristics were analyzed based on urban spatial patterns for Changwon City, South Korea. Twelve ASTER (Advanced spaceborne thermal emission and reflection radiometer) Thermal infrared radiance (TIR) images during the daytime and nighttime from June to September, 2012&ndash, 2014 were used for LST analysis. Air temperature was measured at five meteorological stations. The landcover type, elevation, and location of the meteorological measurement stations were the spatial patterns. The differences among the mean LST for each landcover material were the maximum of 8 &deg, C and 1 &deg, C during the daytime and nighttime, respectively. The LST decreased with increasing built-up area ratio, most prominently in July, but less so with increasing forest area for the same area ratios. The changes of urban temperature according to the spatial pattern were found to be different in each period, and there were some differences from previous studies. This is because the thermal characteristics differ depending on the geographical location, climatic conditions, and building environment of the cities. Therefore, to mitigate the urban heat island continuously, it should be applied to urban planning considering the relationship between spatial patterns and urban temperature, and the urban environment should be considered rather than directly using the results of previous studies.

The purpose of this study is to analyze water cycle area ratio and spatial evaluation of water cycle in urban area of Changwon-si, Gyeongsangnam-do. Water cycle area ratio are analyzed by using spatial data of land-cover and land-use, and Hot spot analysis of GIS program was used for spatial evaluation of water cycle. The results are as below. Firstly, the high water cycle area ratio areas were forests, parks, and rivers, but urban areas covered asphalt and concrete were low under 40%. Public institutions and co-residential of urban areas were higher than others because of high area ratio of pervious land-cover. Spatial evaluation of water cycle was analyzed to vulnerable areas there are dense residential and commercial area. These areas are really occurring frequently flooding and immersion, therefore, is required water management facilities and improvement of land-cover from impervious to pervious. In the future, it will require additionally analysis of water cycle area ratio supplemented data of water management facility and ground water.

The purpose of this study is to evaluate air ventilation using wind patterns of MetPhoMod program at nighttime focused on Changwon-si, Gyeongsangnam-do. Evaluation indices of air ventilation are wind resistant and retention used by results of each wind speed and diversity. The results are as follows. Vulnerable areas of air ventilation are Bonglim-dong, Bansong-dong, Yongji-dong and so on. In high-rise apartment, commercial area and single residential area of Yongji-dong, Sangnam-dong and Sapa-dong, wind is stagnated by high buildings. Therefore, these areas should construct urban spaces to circulate the wind. And to inflow persistingly the fresh wind generated in a rural area, we think that the construction of wind corridor is suggested by development plan and policy wind corridor.

This study is carried out to offer raw data and establish strategy for conservation and restoration of river ecosystem by objective surveying and analysing the flora and vegetation distributed in Hwang river, Gyeongsangnam-do. The flora identified in this site were 406 taxa including 95 families, 252 genera, 360 species, 3 subspecies, 40 varieties and 3 forms. The rare plants were 3 taxa including Sagittaria sagittifolia subsp. leucopetala, Hydrocharis dubia and Acorus calamus. The endemic plants were 4 taxa including Populus tomentiglandulosa, Salix koriyanagi, Paulownia coreana and Weigela subsessilis. The specific plants by floristic region were 17 taxa including Salix siuzevii, Poncirus trifoliata, Potamogeton maackianus and so forth. The naturalized plants were 39 taxa including Phytolacca americana, Chenopodium glaucum, Lepidium virginicum, Oenothera erythrosepala, Xanthium canadense, Lolium multiflorum and so forth. The invasive alien plants were Ambrosia artemisiifolia and Ambrosia trifida. The whole NI and UI were each 9.6% and 13.9%. The hydrophytes were 27 taxa including Marsilea quadrifolia, Nymphaea tetragona, Ceratophyllum demersum, Trapa japonica and so forth. In the results of growth forms of the hydrophytes, emergent species were 14 taxa, 3 taxa of floating-leaved species, 4 taxa of free-floating species and 6 taxa of submerged species. The dominant vegetations were Salix spp. community, Miscanthus sacchariflorus community, Phragmites japonica community and Phragmites communis community.

The purpose of this study is to examine the relationship between children`s walking safety or risk of traffic accident and the physical environments around 20 public elementary schools in Changwon-si, Gyeongsangnam-do. Field surveys were conducted to assess the street-level objective and subjective walking environments. The GIS method was used for measuring the neighborhood-level land use patterns. Children`s walking safety and risk of traffic accident data were collected from the 6,381 grade 5 to 6 students attending 18 elementary schools through the questionnaire survey. Correlation analysis showed that walking safety and risk of traffic accident of the elementary students were associated with the number of temporary or permanent obstacles on the sidewalk, traffic safety signs, driveway and street intersections, street lights, and percentage of detached housing area and road area on neighbourhood-level. This research will promote to help with constructing a safe routes to school and walking-friendly healthy community.

The purpose of this study is to investigate the characteristics of urban heat island considering urban space at nighttime. We used to analyze landuse and landcover data of 1:1,000 scale, DTM, and surface temperature extracted ASTER image satellite of nighttime. According to the analytical results, heat intensity in single-family residential is higher than that in industrial area, public facility area, and commercial area because the anthropogenic heat by energy consumption is released. Likewise, the temperature difference were big in the buildings of industrial area depending on operating hours. Meanwhile, green and river area had cooling impacts mitigating the urban heat island. Therefore, we have to mitigate heat intensity through constructing green space and waterfront area. As mentioned above, we think that the results of this study will be used as base data for effective spatial planning when formulating development planning to mitigate urban heat island at nighttime.

The objective of this paper is to analyze the GIS-based water cycle system: rainfall, evapotranspiration, surface run-off of Gyeongsanam-do for the effective rainwater management. The rainfall(1999~2008) analyzed by a spatial interpolation method, showed relatively higher amount in Hadong-gun, Sanchung-gun, and Sacheon-gun on 2011년 3월 11일 접수 Received on March 11, 2011 / 2011년 5월 2일 수정 Revised on May 2, 2011 / 2011년 5월 30일 심사완료 Accepted on May 30, 2011 1 창원대학교 환경공학과 Dept. of Environmental Engineering, Changwon National University 2 경상남도 보건환경연구원 Gyeongsangnam-do Provincial Institute of Health and Environment ※ 연락저자 E-mail : pureguy55@nate.com 경상남도의 효율적 빗물관리를 위한 GIS 기반 물순환 체계 분석 / 이택순.송봉근.한치복.박경훈 83 the southwest coast than in Changnyeong-gun, Miryang-si, and Changwon-si in the mideast inland. The evapotranspiration was calculated by the three independent variables: air temperature, landuse, and NDVI(normalized difference vegetation index). The analysis showed that Namhae-gun had the highest evapotranspiration of 93.71mm, and Jinhae-si and Changwon-si had the lowest values of 81.78mm and 84.37mm. The surface run-off was analysed by a run-off equation based on the SCS hydrologic soil classification and landuse. The amount of surface run-off showed that Hadong-gun had the highest value, of 90.40mm, and Geochang-gun had the lowest, of 46.69mm. The analysis results of the GIS-based water cycle system will be used to support the establishment of the effective rainwater management plan in Gyeongasngnam-do.

This research tested the applicability of landscape indices for monitoring landscapes in a heavily disturbed environment. Landscape indices were calculated from land cover maps based on Landsat TM data using FRAGSTATS. According to the results, considerable land cover change occurred from 1985 to 1999 due to economic development. In the assessment of landscape structure, forest and agriculture patch types were progressively subdivided into smaller, morphologically simpler as a result of human land use activities. Diversity and configuration of landscape patterns increased, especially in the patches adjacent to forest edge and agriculture. Future research will be directed towards the detection of correlations between landscape patterns and specific environmental and socioeconomic landscape functions.

This study compared Advanced Spaceborne Thermal Emission Reflection Radiometer (ASTER) surface temperature data within situmeasurements to validate the use of ASTER data for studying heat islands in urban settings with complex spatial characteristics. Eight sites in Changwon, Korea, were selected for analyses. Surface temperature data were extracted from the thermal infrared (TIR) band of ASTER on four dates during the summer and fall of 2012, and correspondingin situmeasurements of temperature were also collected. Comparisons showed that ASTER derived temperatures were generally 4.27°C lower than temperatures collected byin situmeasurements during the daytime, except on cloudy days. However, ASTER temperatures were higher by 2.23–2.69°C on two dates during the nighttime. Temperature differences between a city park and a paved area were insignificant. Differences between ASTER derived temperatures and onsite measurements are caused by a variety of factors including the application of emissivity values that do not consider the complex spatial characteristics of urban areas. Therefore, to improve the accuracy of surface temperatures extracted from infrared satellite imagery, we propose a revised model whereby temperature data is obtained from ASTER and emissivity values for various land covers are extracted based onin situmeasurements.