• Title/Summary/Keyword: Approval of use

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Structure of SARS-CoV-2 Spike Glycoprotein for Therapeutic and Preventive Target

  • Jaewoo Hong;Hyunjhung Jhun;Yeo-Ok Choi;Afeisha S. Taitt;Suyoung Bae;Youngmin Lee;Chang-seon Song;Su Cheong Yeom;Soohyun Kim
    • IMMUNE NETWORK
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    • v.21 no.1
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    • pp.8.1-8.17
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    • 2021
  • The global crisis caused by the coronavirus disease 2019 (COVID-19) led to the most significant economic loss and human deaths after World War II. The pathogen causing this disease is a novel virus called the severe acute respiratory syndrome coronavirus 2 (SARSCoV-2). As of December 2020, there have been 80.2 million confirmed patients, and the mortality rate is known as 2.16% globally. A strategy to protect a host from SARS-CoV-2 is by suppressing intracellular viral replication or preventing viral entry. We focused on the spike glycoprotein that is responsible for the entry of SARS-CoV-2 into the host cell. Recently, the US Food and Drug Administration/EU Medicines Agency authorized a vaccine and antibody to treat COVID-19 patients by emergency use approval in the absence of long-term clinical trials. Both commercial and academic efforts to develop preventive and therapeutic agents continue all over the world. In this review, we present a perspective on current reports about the spike glycoprotein of SARS-CoV-2 as a therapeutic target.

Evaluating the Efficacy of Anti-wrinkle Products in USA

  • Kang Sewon
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.29 no.2 s.43
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    • pp.79-104
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    • 2003
  • Introducing to the market place, safe and effective product is an important responsibility of clinical investigators as well as regulatory agencies in all developed countries. Products claiming to improve skin wrinkles are no exceptions. To date, Renova(R) (all-trans retinoic acid), Avage(R) (tazarotene), and Botox(R) (botulinum toxin) are the only agents FDA approved to ameliorate wrinkles associated with photoaged skin in the USA. For all three, clinical evaluation of wrinkle severity was the primary endpoint required for the approval process. No sophisticated instrument measurements of wrinkles were required, nor used in the pivotal studies. The Division of Dermatologic & Dental Products of the US FDA (Director, Jonathan Wilkin, MD) is not against the use of mechanical instruments in assessing wrinkle severity. Its position on this issue however, remains that any such device must be grounded in patients' or product users' perspective, which means that the evaluation instrument must be clinically relevant and clinically perceptible. Sophisticated devices that can detect minimal improvement, but imperceptible to the users are considered useless in the eyes of the US FDA. Two instruments that have been tried in some antiwrinkle studies in the USA are silicone replicas and Primos. Despite their sophistications, they have clear limitations; thus have never replaced clinical evaluations in these studies. At most, they have served as secondary measures to provide corroborative data on the clinical efficacy of antiwrinkle products. For the foreseeable future, at least in the USA, careful clinical assessment of wrinkles will continue to serve as the critical benchmark to determine whether an antiwrinkle product has enough efficacy to benefit its users. We must not lose sight of the fact that sophisticated devices are only to serve in generating supportive evidence, and not the primary evidence, in any clinical studies.

Toxicity of Single-dose Intramuscular Injection of Samjeong Pharmacopuncture in Sprague-Dawley Rats

  • Kwon, Kang;Kim, Chul-Yun;Kim, Nam-Kwen;Sun, Seung-Ho;Seo, Hyung-Sik
    • Journal of Pharmacopuncture
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    • v.18 no.2
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    • pp.60-66
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    • 2015
  • Objectives: This study was carried out in order to find both the single-dose intramuscular injection toxicity and the approximate lethal dose of samjeong pharmacopuncture (SP) in Sprague-Dawley (SD) rats. Methods: The SD rats in this study were divided into four groups, one control group (1.0 mL/animal, normal saline) and three experimental groups (0.25, 0.5, and 1.0 mL/animal, SP). All groups consisted of five male and five female rats. SP was injected as a single-dose intramuscularly at the thigh. After the injection, general symptoms and weight were observed for 14 days. After the observations had ended, hematologic and serum biochemical examinations, necropsy and a local tolerance test at the injection site were performed. The experiments were carried out at the Good Laboratory Practice firm, Biotoxtech Co. (Cheongwon, Chungbuk). Animal experiments were approved by the Ethics Committee (Approval Number: 130379). Results: No deaths occurred in any of the three experimental groups. The injection of SP had no effects on the general symptoms, body weights, results of the hematologic, and serum biochemical examinations, and necropsy findings. In local tolerance tests at the injection sites, mild inflammation was observed in the experimental group, but it did not appear to be a treatment related effect. Conclusion: Under the conditions of this test, the results from the injection of SP suggest that the approximate lethal dose of SP is above 1.0 mL/animal for both male and female SD rats. Therefore, the clinical use of SP is thought to be safe.

Perspective vaccines for emerging viral diseases in farm animals

  • Ahmad Mohammad Allam;Mohamed Karam Elbayoumy;Alaa Abdelmoneam Ghazy
    • Clinical and Experimental Vaccine Research
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    • v.12 no.3
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    • pp.179-192
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    • 2023
  • The world has watched the emergence of numerous animal viruses that may threaten animal health which were added to the perpetual growing list of animal pathogens. This emergence drew the attention of the experts and animal health groups to the fact that it has become necessary to work on vaccine development. The current review aims to explore the perspective vaccines for emerging viral diseases in farm animals. This aim was fulfilled by focusing on modern technologies as well as next generation vaccines that have been introduced in the field of vaccines, either in clinical developments pending approval, or have already come to light and have been applied to animals with acceptable results such as viral-vectored vaccines, virus-like particles, and messenger RNA-based platforms. Besides, it shed the light on the importance of differentiation of infected from vaccinated animals technology in eradication programs of emerging viral diseases. The new science of nanomaterials was explored to elucidate its role in vaccinology. Finally, the role of Bioinformatics or Vaccinomics and its assist in vaccine designing and developments were discussed. The reviewing of the published manuscripts concluded that the use of conventional vaccines is considered an out-of-date approach in eliminating emerging diseases. However, these types of vaccines are considered the suitable plan especially in countries with few resources and capabilities. Piloted vaccines that rely on genetic-based technologies with continuous analyses of current viruses should be the aim of future vaccinology. Smart genomics of emerging viruses will be the gateway to choosing appropriate vaccines, regardless of the evolutionary rates of viruses.

Gender Differences in Responses towards Anti-Smoking Messages and Policy Implementation among Future Doctors in Malaysia

  • Yasin, Siti Munira;Ismail, Nurhuda;Noor, Norizal Mohd;Azman, Mohd Shafiq Mohd;Taib, Hanisah;Jusop, Junainah Mat;Salaudin, Nur Atirah
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.1
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    • pp.303-308
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    • 2013
  • Background: Medical students' views may provide some direction for future policy considerations. Aim: The aim of this study was to assess gender differences in future doctors' receptiveness to currently implemented anti-smoking messages and the effectiveness of those messages. Materials and Methods: We administered a questionnaire to all students at a medical university in Malaysia, asking how frequently they noted anti-smoking policies, anti-smoking campaigns, and anti-smoking messages in schools. In addition, the questionnaire investigated most effective methods to convey these messages. Results: A total of 522 (59.7%) students responded. Students were least likely to approve of total bans on cigarettes and increasing the price of cigarettes, and most likely to approve of bans on use of cigarettes in public places and sales to individuals less than 16 years old. Approval of total bans on cigarettes was more common in female students than in males OR=0.39 (95%CI: 0.18-0.86). Furthermore, compared to the female students, the male students thought that printed media; OR=2.32 (95%CI: 1.31-4.10), radio; OR=1.93 (95%CI: 1.15-3.22) and the internet; OR=1.96 (95%CI: 1.15-3.33) were very effective at delivering anti-smoking messages. Conclusions: Gender differences existed in the future doctors' perception of the effectiveness of anti-smoking initiatives. Taking this gender difference into account may increase the receipt of anti-smoking messages in adolescents.

Single-dose Intramuscular-injection Toxicology Test of Water-soluble Carthami-flos and Cervi cornu parvum Pharmacopuncture in a Rat Model

  • Park, Sunju;Sun, Seung-Ho
    • Journal of Pharmacopuncture
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    • v.18 no.3
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    • pp.42-48
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    • 2015
  • Objectives: The aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 mL/animal.

A Study on the Practical Use of Human Alertness for Flight Safety Program (비행안전 프로그램으로서의 생체 활성도 활용방안 연구)

  • Lee, Dal-Ho;Choe, Seung-Ho
    • Journal of the Ergonomics Society of Korea
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    • v.17 no.3
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    • pp.13-22
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    • 1998
  • Aircraft and the three-dimensional environment in which they operate are not user-friendly for human beings. As a result, maintaining the proficiencies necessary to safely and efficiently fly an airplane are difficult, and costly. The physiological and emotional status of the human element remains crucial in maintaining safe performance by all crew members. In the study of Hagiwara et al.(1993). they called the physiological and emotional status of the human element into the human alertness or physiological activity and stress, fatigue, circadian rhythm, alcohol. smoking, and self-medication are known the major factors that deteriorate the human alertness. Accordingly. this paper deals with the quantitative and objective performance test based on tracking error and reaction time by means of the new computer test program into which the perception-motion system of human beings is applied. Throughout this experiment using performance test, the results suggest that performance capability in state of sleep deprivation 2 hours and alcoholic 0.05~0.06% in blood were more impaired than one in a normal state, and they further showed statistically significant differences between them, which were influenced by impairment factors of body regulation and pilot's grade. We also obtained the prediction value and the 95% confidence interval of tracking error and reaction time at the normal state for the purpose of distinguishing performance capability between the normal state and the abnormal state. And it is expected that the evaluation of human alertness using performance test will be applied to the quantitative assessment of an each pilot's realistic consciousness/attention, and will lead a flight commander to the accurate decision of mission approval prior to a flight.

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A Review of the Jindo, Korean Native Dog - Review -

  • Lee, C.G.;Lee, J.I.;Lee, C.Y.;Sun, S.S.
    • Asian-Australasian Journal of Animal Sciences
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    • v.13 no.3
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    • pp.381-389
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    • 2000
  • The Jindo is a Korean native dog, well-known for its hunting and guarding abilities. When he gives his devotion to one individual, he gives it whole-heartedly. He is not tempted easily and impetuous. The breed was not developed. but the dog retained their original qualities -loyal, alert, fearless, obedient, watchful, intelligent, energetic- to survive in the harsh environment of the Jindo island. The dog had been spread over the entire Korean peninsula from the time unknown, and the ones in the Jindo island, isolated until lately, survived and maintained their original characteristics. They are now spread over the entire Jindo County consisted of many islands, whence the breed name came. The Jindo comes in a variety of colors and color combinations, with the fawn and white colorings predominant. The dog is one of the Korean natural monuments, protected by law since early 1960s. The Jindo gained official approval by the Federation Cynologique Internationale as a hunting dog. Apart from the basic housetraining, the dog rarely gets training. Many people have attempted to preserve its pure bloodlines and original qualities. Today, there are a total of 10,356 Jindoes being raised over the entire Jindo County, and many more are kept elsewhere. A research into genetic characteristics of the Jindo is now going on, using the technique of isozyme electrophoresis. The Jindo Dog Breeding Management Center has been reinforced lately, and in addition to their routines, the Center is to work on the breeding of the Jindo. Efforts should be made in the future to produce stable, trustworthy Jindoes according to their proposed use and to modify their temperament in order to make it more widely acceptable as a pet and companion dog in the strangers home.

Stability Evaluation during Transportation of Offshore Wind Turbine by Barge (바지선을 이용한 해상풍력발전기 운반에 따른 안정성 평가)

  • Seok, Jun;Back, Young-Soo;Park, Jong-Chun;Kim, Sung-Yong;Cha, Tae-Hyung;Yang, Young-Jun
    • Journal of the Society of Naval Architects of Korea
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    • v.54 no.3
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    • pp.196-203
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    • 2017
  • In general, the installation of offshore wind turbine have been carried out by a jack-up barge or wind turbine installation vessel. In case of using jack-up barge, an additional barge is required to transport offshore wind turbines. During the transportation, barge is affected by environmental conditions such as wave, wind etc. So, it is important to secure the static and dynamic stability of the barge. In this study, fundamental research was performed to evaluate the stability of barge due to use the guide frame. The analysis for static stability of barge was performed under the two loading conditions with or without wave and those results were evaluated according to the Ministry of Oceans and Fisheries rules. Also motion analysis was performed under the ITTC wave spectrum using buoy data and evaluated based on NORDFORSK guideline by using commercial software Maxsurf Motions.

A Study on big data utilization for implementation of the resident participation type safe community planning of the smart city (스마트시티의 주민참여형 안전도시 계획을 위한 빅데이터 활용에 관한 고찰)

  • Chang, Hye-Jung;Kim, Do-Nyun
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.9 no.5
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    • pp.478-495
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    • 2016
  • The existing city planning was performed by internal few decision-maker, but the information that an individual could contact with through the evolution of the ICT technology increased in the smart city, and a channel diversified and came to be able to participate in a decision making process by various methods. I show that it is in the collaborative planning process to come to a mutual understanding with residents directly or indirectly if utilize big data in a process of the safe community planning of the smart city. Therefore, I compare the utilization contents between data of Matsubara-shi,Japan and data of certification city of Korea which received the certification of the WHO international safe community. In the area where this study prepares for the approval of the international safe community, it wants you to use it though you utilize the data as the supporting role of the residents participation plan.