• Title/Summary/Keyword: data recover

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The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.223-259
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    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

A Study on Woman's Experience of Being Bereaved of Her Husband by an Accident (사고로 남편을 잃은 여성의 경험)

  • Park, Sung-Hark;Choi, Mi-Hye;Chung, Yeon-Kang
    • Research in Community and Public Health Nursing
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    • v.7 no.2
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    • pp.294-312
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    • 1996
  • Relatively young widows, who are left with young children by a sudden death of their husbands, will be faced with not only psychological troubles such as individual anxiety and frustration but also the dual burden of playing both father and mother roles in a family, Also, family members have difficulty in adapting themselves to new circumstances of the family system, the training and raising of family members, and management of the family economy. In this study, the realistic resources on the experience of middle-aged women who are bereaved of their husbands by accidents were explored. The purpose of this study is to help widows adapt to life in society and live a more positive life by setting a new goals and recovering from a lost and twisted life. 11 women, who have experienced the loss their husbands and live in the Seoul metropolitan area were studied. The research took 116 days from December 15, 1995 to April 8, 1996. The method of research was direct interviews. While having interviews with them, the contents were recorded with their consent. The ground theory was that used by Strauss & Corbin(1990) in the analysis of the data. 81 concepts were analyzed and they were subdirided into 22 subordinate categories through the course of the analysis. These were then classified into 9 general categories. In the course of being categorized, 'absurdity' was showed as a core category. The subordinate categories 'surprise', 'gloom', 'grudge', 'helplessness', 'emptiness', and 'loss' were united in the core category 'absurdity'. Ominous presentiment, belated notice, death, surprise, gloom, grudge, helplessness, emptiness, loss, the situation of the children, lack of support from neighbors, support from neighbors, mulling over ways to live, choosing a job, strengthening, reinforcement, burden, sadness, smoldering, yearning, overcoming these 22 subordinate categories were re-composed into 9 general ones the husband's death, absurdity, presence of children, existence of support, self-support ability, preparation of countermeasures, self-reinforcement, toilsomeness, and overcoming. 'Absurdity' widows experience was shown in the results of 'toilsomeness' and 'overcoming' through reaction, confrontation, and adaptation. According to the analysis the central phenomenon was absurdity, the causal condition of the death of a husband, the presence of children and the existence of support, and the meditated situation of self-support. To solve absurdity, the preparation of countermeasures and self-reinforcements were shown resulting in toilsomeness and overcoming. Through the contrast in the data, the following statements were deduced: (1) If the death of the husband is expected, the more a widow will feel absurdity. (2) The more children she has and the younger she is, the more a widow will feel absurdity. (3) The lower support she is given, the more a widow will feel absurdity. (4) The larger self-ability she has, the more actively she will prepare countermeasures. (5) The smaller self-ability she has, the more passively she will prepare countermeasures. (6) The larger self-ability she has, the weaker self-reinforcement she will preform. (7) The smaller self-ability she has, the stronger self-reinforcement she will perform. (8) The more actively she prepares countermeasures for absurdity, the better she will overcome. (9) The more passively she prepares counter measure for absurdity, the worse she will overcome. (10) The stronger self-reinforcement for absurdity she performs, the better she will overcome. (11) The weaker self-reinforcement for absurdity she performs, the worse she will overcome. Through the results in this study, the following suggested: 1) A study whose object is all family members, and a comparative study on the case of a husband who has lost his wife should be done. These studies can be expected to develop a more refined theory. 2) Because of the collapse of the extended family system and the changes of family culture in Korea, a widow's status and position are apt to be ambiguous between her husband's home and her parent's. Therefore a new study on family culture should be made. 3) A continuous study on growing social Self Help Groups should be requested for the widows of this study to re-establish and recover from their twisted and scattered lives.

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Effects of Elbow Ulnar Collateral Ligament Injury on Differences in Maximal Isometric Strength of Upper body in Young Baseball Pitchers (주니어 투수들의 팔꿈치 안쪽 곁인대 손상이 상지 근육의 최대등척성수축력 차이에 미치는 영향)

  • Jang, Sehong;Kim, Donghee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.10
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    • pp.628-634
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    • 2016
  • Many pitchers suffer from various types of injury (distortion, sprain and so on). The rate of injury is increased if there are differences in strength between the extensor and flexor muscles when a joint movement is performed with maximum speed. However, there has been insufficient research into the injury caused by strength differences between the extensor and flexor muscles. Thus, the purpose of the study was to examine the effects of elbow ulnar collateral ligament injury on the maximal isometric strength in young baseball pitchers. The data collection was conducted for 2 weeks. The subjects (n=36) who participated in this study were placed into either the injury group (n = 18, IG) or normal group (n = 18, NG). The maximal isometric strength for the pectoralis major (PM), infraspintus (I), biceps brachii (BB), triceps brachii (TB), flexor carpi radialis (ECR) and extensor carpi radialis (FCR) muscles were determined by an isometric strength machine (K-DFX) and then the differences in strength were calculated by muscle group. All of the data were analyzed by SPSS 18.0 with the independent t-test. In the results, the maximal isometric strengths in the IG for the I (p=0.035), BB (p=0.031) and TB (p=0.041) were significantly lower than those in the NG, while that for the ECR (p=0.047) was significantly greater. In addition, the differences of the maximal isometric strength between the PM and I (p = 0.008), BB and TB (p = 0.002), and FCR and ECR (p = 0.032) in the IG were significantly greater than those in the NG. In conclusion, the differences in muscle strengths of the subjects in the IG were greater than those in the NG, which suggests that they might have a higher injury rate in the future. However, they might be able to recover from their injury and achieve better performance if the differences in strength were reduced by training.

Analysis of the Entrance Surface Dose (ESD) and Contrast Usage of Trance Femoral Cerebral Angiography (TFCA) and Cerebral Computed Tomographic Angiography (CCTA) for Cerebrovascular Disease Examining (뇌혈관 질환 검사를 위한 뇌혈관 조영술(TFCA)과 뇌혈관 전산화 단층 촬영 검사(CCTA)의 입사표면선량(ESD) 및 조영제 사용량 분석)

  • Seo, Young-Hyun;Hong, Cheon-Gi;Song, Jong-Nam
    • Journal of the Korean Society of Radiology
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    • v.13 no.4
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    • pp.495-502
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    • 2019
  • A typical cerebrovascular disease among cerebrovascular diseases is vascular diseases such as cerebral infarction, cerebral hemorrhage, cerebral aneurysm, cerebrovascular stenosis. If the disease occurs and causes cerebral damage, it may be difficult to recover completely. So that, Must continue to perform health care through examination early. In particular, Because most cerebrovascular disease examining use radiation equipment and Thus this study was to find out how to select about the optimal examining method and X-ray dose decrease method among different examining method though comparison and analysis for the entrance surface dose (ESD) on cerebrovascular examining with Trance Femoral Cerebral angiography (TFCA) and Cerebral Computed Tomographic Angiography (CCTA). Also, want to find out how to select about the optimal examining method for worried patient that contrast medium side effect though measuring and evaluating for contrast usage. Data were collected from 70 patients (43 males and 27 females) who underwent CCTA at Yeosoo region hospital from June 2018 to December 2018 and 61 patients (34 males and 27 females) who underwent TFCA at Pyeongtaek region hospital from June 2018 to November 2018. ESD analysis method collected retrospective data though M-view and PACS PLUS program, Used contrast usage measuring method did reality measuring method. In the analysis using SPSS, the ESD of TFCA was $245.74{\pm}71.91$, which was $32.05{\pm}7.74$ lower than the dose of $277.79{\pm}79.65$ of CCTA ESD, and statistically significant at t = 3.249, p = 0.017 (p<0.05). As a result of the comparison of the total amount of contrast agent, the mean contrast agent used in TFCA was $55.05{\pm}17.68ml$, which was about 14.95 smaller than the amount of contrast agent used in CCTA, and statistically significant t = -4.548, p<0.001. In conclusion, the ESD of TFCA was statistically significantly lower than that of CCTA, and also the used contrast usage was significantly tiny than that of CCTA. Therefore, Select the method to increase the utilization of TFCA for cerebral disease examining, we can consider X-ray dose decrease method at the same time as to decrease side effect of contrast medium.

An Qualitative Study on Correctional institution Counselors' Perception of Ex-Offender's Experience regarding Reintegration into Family (수감자의 출소 후 가족복귀 경험에 관한 교정기관 상담자의 인식)

  • Dong Hun Lee ;Su Eun Kang ;Seung Hee Jee
    • Korean Journal of Culture and Social Issue
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    • v.22 no.4
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    • pp.595-622
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    • 2016
  • This study aims to understand the process of family reunion of the ex-offenders. To this end, Korea Rehabilitation Agency under Ministry of Justice and Healthy Family Support Center conducted intensive interviews with ex-offenders, their families and with 8 counselors who are in charge of ex-offenders and their families' residential, psychological, and educational support. The data collected through the interviews were analyzed by Consensus Qualitative Research(COR). The followings are the results: the counselors found out that most of ex-offenders had experienced unhappy childhood which was lack of healthy relationship with their parents. Secondly, counselors noticed a common feature among the families of ex-offenders. The common feature was that they keep the fact that one of their parents was imprisoned to their children as a secret. Thirdly, through the data analysis, counselors could understand various factors that affect reunion of ex-offenders' families: the factors that helped successful reunion were ex-offenders' sense of responsibility, open and healthy communication among family members, and mutual understanding of being a good family member, whereas, irresponsible dependance to other family members, denier and avoidance from the family members against ex-offenders, and lost sense of being a family member were the factors that discouraged the reunion. It turned out that the kinds of crime that ex-offenders committed also affected family reunion. The processes of reunion were easier for those who served their time with fraud, embezzlement, whereas, it was much more challenging for those who served their time with rape, violence, or murder. Fourthly, counselors learned that "relaxation" is the key factor in the process of reunion of ex-offenders' families. They also emphasized that there should be thorough monitoring process before the intervention in the reunion process. This study contributes in terms of finding healthy ways of intervention with ex-offenders' families and developing programs that help ex-offenders to recover their relationship with their family.

Interpretation of Microscale Behaviors and Precision Measurement Monitoring for the Five-story and Seven-story Stone Pagodas from Cheongnyangsaji Temple Site in Gongju, Korea (공주 청량사지 오층석탑 및 칠층석탑의 정밀 계측모니터링과 미세거동 해석)

  • LEE Jeongeun;PARK Seok Tae;LEE Chan Hee
    • Korean Journal of Heritage: History & Science
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    • v.56 no.4
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    • pp.132-158
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    • 2023
  • The five-story and seven-story stone pagodas at Cheongnyangsaji temple site in Gongju are located under the Sambulbong peak of Gyeryongsan mountain, and are known to have been built of the middle in Goryeo dynasty. As the two pagodas in which two types of Baekje stone pagoda coexist in one era, their historical and academic value are recognized. The seven-story pagoda was overturned by robbery in 1944, and as a result, the five-story pagoda was tilted. Although the two pagodas were restored in 1961, structural instability was continuously raised. In this study, measurement data accumulated from May 2021 to March 2022, and seasonal characteristics were reviewed, and the micro behavior of pagodas were analyzed according to temperature and precipitation during the same period. As a result, the micro thermoelastic behavior was repeated according to the daily temperature change in all sensors, and both the slope and the displacement showed microscale behavior. In the inclinometer, moisture containing the surface and inside of the stones repeated expansion and contraction due to temperature change, showing the micro movements. In particular, the upper part of the five-story pagoda moved up to 3.89° to the northwest, and the seven-story pagoda tilted up to 0.078° to the northeast. The maximum displacements were recorded as 0.127 and 0.149 mm in the five-story and the seven-story pagoda, respectively. These values tended to return to the original position at the end of the measurement, but did not recover completely, indicating a state requiring precise monitoring. The result obtained through the study can be used as basic data for the stable conservation of the two stone pagodas. Based on the behavioral characteristics considering various environmental factors should be analyzed, and the preventive conservation through the maintenance of measurement system built this time should be continued.

Characteristics of Vegetation Structure of Burned Area in Mt. Geombong, Samcheok-si, Kangwon-do (강원도 삼척 검봉산 일대 산불 피해복원지 식생 구조 특성)

  • Sung, Jung Won;Shim, Yun Jin;Lee, Kyeong Cheol;Kweon, Hyeong keun;Kang, Won Seok;Chung, You Kyung;Lee, Chae Rim;Byun, Se Min
    • Journal of Practical Agriculture & Fisheries Research
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    • v.24 no.3
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    • pp.15-24
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    • 2022
  • In 2000, a total of 23,794ha of forest was lost due to the East Coast forest fire, and about 70% of the damaged area was concentrated in Samcheok. In 2001, artificial restoration and natural restoration were implemented in the damaged area. This study was conducted to understand the current vegetation structure 21 years after the restoration of forest fire damage in the Samcheok, Gumbong Mountain area. As a result of classifying the vegetation community, it was divided into three communities: Quercus variabilis-Pinus densiflora community, Pinus densiflora-Quercus mongolica community, and Pinus thunbergii community. Quercus variabilis, Pinus densiflora, and Pinus thunbergii planted in the artificial restoration site were found to continue to grow as dominant species in the local vegetation after restoration. As for the species diversity index of the community, the Quercus variabilis-Pinus densiflora community dominated by deciduous broad-leaf trees showed the highest, and the coniferous forest Pinus thunbergii community showed the lowest. Vegetation in areas affected by forest fires is greatly affected by reforestation tree species, and 21 years later, it has shown a tendency to recover to the forest type before forest fire. In order to establish DataBase for effective restoration and to prepare monitoring data, it is necessary to construct data through continuous vegetation survey on the areas affected by forest fires.

Effects of Artificial Saliva Contamination on the Bond Strength of Three Dentin Adhesives to Dentin of Primary Teeth (인공타액오염이 유치 상아질에서 3종 상아질 접착제의 결합 강도에 미치는 영향)

  • Bae, Youngeun;Kim, Shin;Jeong, Teasung;Kim, Jiyeon
    • Journal of the korean academy of Pediatric Dentistry
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    • v.44 no.1
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    • pp.72-81
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    • 2017
  • The aim of this study was to evaluate the effectiveness of artificial saliva contamination and decontamination procedures at different stages of a bonding procedure on the microtensile bond strength (MTBS) of two one-step self-etch adhesives and a two-step total-etch adhesive to dentin of primary teeth. Forty-two extracted sound primary molars were randomly divided into three groups depending on three adhesives, Scotchbond Universal Adhesive (SBU), All-Bond Universal (ABU) and Prime & Bond NT (PNT). For each adhesive, the teeth were allocated into seven groups. Except for control group, group 1, the groups were contaminated with artificial saliva at three different stages: the groups 2 and 3 - before adhesive application; the groups 4 and 5 - before adhesive polymerization; the groups 6 and 7 - after adhesive polymerization. Decontaminating procedures were rinsing, air-drying (group 2, 4, 6) and air-drying (group 3, 5, 7). The specimens were restored with composite resin (Filtek, Z350) and microtensile bond strength was measured. The data was analyzed with one-way ANOVA and Tukey HSD test (p < 0.05). In the control group, using PNT resulted in significantly higher bond strength than when ABU and SBU were used (p < 0.001). For three adhesives, the groups 2, 4 and 6 had greater bond strength than the groups 3, 5 and 7. Also, when the artificial saliva was contaminated before adhesive polymerization (group 4, 5), it showed a significantly lower bond strength. Generally the two-step total-etch adhesive generated a higher bond strength than the one-step self-etch adhesive. Artificial saliva contamination before adhesive polymerization led to a drastic decrease in bond strength, and rinsing with water followed by air-drying could not recover the bond strength.

Estimation of the Required Number of Fan Coil Unit for Surplus Solar Energy Recovery of Greenhouse (온실의 잉여 태양에너지 회수용 FCU 소요대수 검토)

  • Yun, Sung-Wook;Choi, Man Kwon;Kim, Ha Neul;Kang, Donghyeon;Lee, Siyoung;Son, Jinkwan;Yoon, Yong Cheol
    • Journal of Bio-Environment Control
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    • v.25 no.2
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    • pp.83-88
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    • 2016
  • In this study, previously reported surplus solar energy-related study result and current status of fan coil unit (FCU) for cooling and heating installed in the current sites were briefly examined and then a method to determine the number of FCUs required to recover surplus solar energy was schematically proposed to provide basic data for researchers and technical engineers in this field. The maximum, mean, and minimum outside temperatures during the experiment period were about $28.2^{\circ}C$, $4.4^{\circ}C$, and $-11.5^{\circ}C$, respectively. The horizontal surface solar radiation level outside the greenhouse was in a range of $0.8-20.5MJ{\cdot}m^{-2}$ and mean and total solar radiation were $10.8MJ{\cdot}m^{-2}$ and $1,187.5MJ{\cdot}m^{-2}$. The mean temperature and relative humidity in the greenhouse during the daytime were in a range of 18.8-45.5 and 53.5-77.5%. The total surplus solar energy recovered from the greenhouse during the experiment period was approximately 6,613.4MJ, which could supplement about 6.7% of the total heating energy 98,600.2 MJ. In addition, the number of FCUs installed for heating varies case to case, although similar FCUs are used. Thus, it is necessary to study the installation height, orientation and installation distance as well as the appropriate number of FCUs from the efficient and economical viewpoints. The required numbers of FCUs for surplus solar energy recovery were 8.4-10.9units and 6.1-8.0units based on air mass and circular flow rate that passed through the FCUs. Considering calculation methods and the risks such as efficiency and use environments of FCUs, it was found that about nine units (one unit per $24m^3$ approximately) needed to be installed. The required number of FCUs for surplus solar energy recovery was around one unit per $24m^3$ approximately.

An Embedding /Extracting Method of Audio Watermark Information for High Quality Stereo Music (고품질 스테레오 음악을 위한 오디오 워터마크 정보 삽입/추출 기술)

  • Bae, Kyungyul
    • Journal of Intelligence and Information Systems
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    • v.24 no.2
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    • pp.21-35
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    • 2018
  • Since the introduction of MP3 players, CD recordings have gradually been vanishing, and the music consuming environment of music users is shifting to mobile devices. The introduction of smart devices has increased the utilization of music through music playback, mass storage, and search functions that are integrated into smartphones and tablets. At the time of initial MP3 player supply, the bitrate of the compressed music contents generally was 128 Kbps. However, as increasing of the demand for high quality music, sound quality of 384 Kbps appeared. Recently, music content of FLAC (Free License Audio Codec) format using lossless compression method is becoming popular. The download service of many music sites in Korea has classified by unlimited download with technical protection and limited download without technical protection. Digital Rights Management (DRM) technology is used as a technical protection measure for unlimited download, but it can only be used with authenticated devices that have DRM installed. Even if music purchased by the user, it cannot be used by other devices. On the contrary, in the case of music that is limited in quantity but not technically protected, there is no way to enforce anyone who distributes it, and in the case of high quality music such as FLAC, the loss is greater. In this paper, the author proposes an audio watermarking technology for copyright protection of high quality stereo music. Two kinds of information, "Copyright" and "Copy_free", are generated by using the turbo code. The two watermarks are composed of 9 bytes (72 bits). If turbo code is applied for error correction, the amount of information to be inserted as 222 bits increases. The 222-bit watermark was expanded to 1024 bits to be robust against additional errors and finally used as a watermark to insert into stereo music. Turbo code is a way to recover raw data if the damaged amount is less than 15% even if part of the code is damaged due to attack of watermarked content. It can be extended to 1024 bits or it can find 222 bits from some damaged contents by increasing the probability, the watermark itself has made it more resistant to attack. The proposed algorithm uses quantization in DCT so that watermark can be detected efficiently and SNR can be improved when stereo music is converted into mono. As a result, on average SNR exceeded 40dB, resulting in sound quality improvements of over 10dB over traditional quantization methods. This is a very significant result because it means relatively 10 times improvement in sound quality. In addition, the sample length required for extracting the watermark can be extracted sufficiently if the length is shorter than 1 second, and the watermark can be completely extracted from music samples of less than one second in all of the MP3 compression having a bit rate of 128 Kbps. The conventional quantization method can extract the watermark with a length of only 1/10 compared to the case where the sampling of the 10-second length largely fails to extract the watermark. In this study, since the length of the watermark embedded into music is 72 bits, it provides sufficient capacity to embed necessary information for music. It is enough bits to identify the music distributed all over the world. 272 can identify $4*10^{21}$, so it can be used as an identifier and it can be used for copyright protection of high quality music service. The proposed algorithm can be used not only for high quality audio but also for development of watermarking algorithm in multimedia such as UHD (Ultra High Definition) TV and high-resolution image. In addition, with the development of digital devices, users are demanding high quality music in the music industry, and artificial intelligence assistant is coming along with high quality music and streaming service. The results of this study can be used to protect the rights of copyright holders in these industries.