• Title/Summary/Keyword: The medicine approval

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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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    • 제14권1호
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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.

전문간호사 자격관리 전문기관의 조직 및 운영(안) (Model of The Korea Regulatory Body of Advanced Practice Registered Nurse)

  • 조재현;김기경
    • 간호행정학회지
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    • 제10권4호
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    • pp.437-448
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    • 2004
  • Purpose: The study was done to develop the model of regulatory body of advanced practice registered nurse. Method: This was a descriptive study adopted a method of comparison and construction of laws. Result: The type of partnership of government and people were privatization, negotiated rule-making, standard-setting authority, self-regulation. The pattern of partnership were applied to the regulatory body's role; administration of certification and examination, setting standards for nursing education programs and approval nursing programs. The regulatory body of advanced practice registered nurse was organized according to it's role. Conclusions: It is needed to proceed to self-regulation step by step.

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Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing

  • Yim, Seon-Hee;Chung, Yeun-Jun
    • Genomics & Informatics
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    • 제12권4호
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    • pp.151-155
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    • 2014
  • In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

Sanitation and Tissue Residue Problems in High Quality Pork - Review -

  • Lee, M.H.;Ryu, P.D.
    • Asian-Australasian Journal of Animal Sciences
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    • 제12권2호
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    • pp.233-243
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    • 1999
  • Food safety or sanitation are terms broadly applicable to procedures designed to ensure that food quality is high and free of factors which may adversely affect human health. These factors include zoonotic diseases and acute and chronic effects of ingesting natural and human-made xenobiotics. Use of drugs in animal production for the treatment and control of animal diseases, to promote growth rate, and to improve feed conversion efficiency has expanded year by year, thus increasing the possibilities for occurrences in animal products of residues harmful to humans. Governmental agencies have made efforts to control or prevent residue problems. The Korean Food and Drug Administration (KFDA) is charged with the responsibility of establishing tolerances for veterinary drugs, pesticides, and mycotoxins and other non-pharmaceutical substances. The Department of Veterinary Service is responsible for establishing guidelines regarding withdrawal times of drugs, approval of drugs, their uses, and sanitation enforcement of livestock products. The authors describe the toxicological basis for the establishment of tolerance levels for xenobiotics and the pharmacokinetic basis for establishing withdrawal time for veterinary drugs. The regulatory tolerance levels of chemicals in pork and swine feed, Korean regulations on the use of feed additives, rapid residue test methods, the National Residue Program, and the Food Animal Residue Avoidance Databank are discussed. Rapid EIA methods that are under development for the screening of live animals are described These methods predict tissue residues from an examination of blood samples taken from pigs before they are slaughtered.

Decision Tree of Occupational Lung Cancer Using Classification and Regression Analysis

  • Kim, Tae-Woo;Koh, Dong-Hee;Park, Chung-Yill
    • Safety and Health at Work
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    • 제1권2호
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    • pp.140-148
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    • 2010
  • Objectives: Determining the work-relatedness of lung cancer developed through occupational exposures is very difficult. Aims of the present study are to develop a decision tree of occupational lung cancer. Methods: 153 cases of lung cancer surveyed by the Occupational Safety and Health Research Institute (OSHRI) from 1992-2007 were included. The target variable was whether the case was approved as work-related lung cancer, and independent variables were age, sex, pack-years of smoking, histological type, type of industry, latency, working period and exposure material in the workplace. The Classification and Regression Test (CART) model was used in searching for predictors of occupational lung cancer. Results: In the CART model, the best predictor was exposure to known lung carcinogens. The second best predictor was 8.6 years or higher latency and the third best predictor was smoking history of less than 11.25 pack-years. The CART model must be used sparingly in deciding the work-relatedness of lung cancer because it is not absolute. Conclusion: We found that exposure to lung carcinogens, latency and smoking history were predictive factors of approval for occupational lung cancer. Further studies for work-relatedness of occupational disease are needed.

The effect of stabilization exercise on pain-related disability, sleep disturbance, and psychological status of patients with non-specific chronic low back pain

  • Akodu, Ashiyat Kehinde;Akindutire, Oluwagbemisola Marian
    • The Korean Journal of Pain
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    • 제31권3호
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    • pp.199-205
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    • 2018
  • Background: Sleep disturbance and depression are becoming more recognized as important symptoms among individuals with chronic low back pain. This study evaluated the effect of stabilization exercise on pain-related disability, sleep disturbance and the psychological status of patients with non-specific chronic low back pain (NSCLBP). Methods: A total of 26 patients (M/F = 17/9) with NSCLBP with a mean age of $50.0{\pm}15.5$ took part in this study. Participants were recruited from selected hospitals in Lagos state. Ethical approval was sought and obtained from the health research and ethics committee of Lagos University Teaching Hospital Idi-araba, Lagos, Nigeria. Participants performed stabilization exercise for eight weeks consecutively and were assessed for pain-related disability, anxiety, depression, and sleep disturbance using the pain-disability index, hospital anxiety and depression scale, and the insomnia severity index at baseline, the 4th week, and the 8th week, postintervention. Results: The participants studied recorded significant reduction in pain-related disability (P = 0.001). There was also improvement in the sleep quality (P = 0.001), depression level (P = 0.001), and anxiety level (P = 0.001), post intervention. Conclusions: This study revealed that stabilization exercise is very useful in the management of sleep disturbance, pain-related disability, depression, and anxiety in NSCLBP patients.

A Randomised, Placebo-controlled Trial of the Effects of Preoperative Pregabalin on Pain Intensity and Opioid Consumption following Lumbar Discectomy

  • Hegarty, Dominic A.;Shorten, George D.
    • The Korean Journal of Pain
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    • 제24권1호
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    • pp.22-30
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    • 2011
  • Background: Pregabalin has been shown to have analgesic effect in acute pain models. The primary objective was to examine the efficacy a single dose of pregabalin, would have on morphine consumption following lumbar discectomy. Methods: With ethical approval a randomized, placebo-controlled prospective trial was undertaken in 32 patients (ASA I-II, 18-65 years) with radicular low back pain for > 3 months undergoing elective lumbar discectomy. Patients received either oral pregabalin 300 mg (PG Group) or placebo (C Group) one hour before surgery. Pain intensity, the accumulative morphine consumption and adverse effects were recorded for 24 hours following surgery. Functional, psychological and quantitative sensory testing were also assessed. Results: Fourteen patients out of the 32 recruited were randomized to receive pregabalin. Morphine consumption was reduced (absolute difference of 42.3%) between groups with medium effect size. (Mann-Whitney; U =52.5, z-score= 2.84, P = 0.004, r = 0.14). This was not associated with a significant difference in the incidence of adverse effects between the two groups. The median pain intensity (VAS) on movement was not significantly different between groups. Conclusions: A single pre-operative dose of pregabalin (300 mg) did not result in a reduction in pain intensity compared to placebo in this patient cohort but the significant reduction in morphine consumption suggests that a fixed peri-operative dosing regime warrants investigation.

알츠하이머병의 최신지견 (Recent Advances in Diagnosis and Treatment of Alzheimer's Disease)

  • 이정재;이석범
    • 생물정신의학
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    • 제23권2호
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    • pp.48-56
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    • 2016
  • Alzheimer's disease (AD) is a neurodegenerative disorder in which neuronal loss causes cognitive decline and other neuropsychiatric problems. It can be diagnosed based on history, examination, and appropriate objective assessments, using standard criteria such as the Diagnostic and Statistical Manual of Mental Disorders or the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA). Brain imaging and biomarkers are making progress in the differential diagnoses among the different disorders. The cholinesterase inhibitors, donepezil, rivastigmine and galantamine and N-methyl-D-aspartate receptors antagonist memantine are approved by the US Food and Drug Administration for AD. Recently some acetylcholinesterase inhibitors gained approval for the treatment of severe AD and became available in a higher dose formulation or a patch formulation. Optimal care in AD is multifactorial and it should include early diagnosis and multidisciplinary care with pharmacological and nonpharmacological interventions including exercise interventions, cognitive interventions and maintenance of social networks.

Packet Transceiver on 2.4GHz for Whooper Swan

  • Nakada, Kaoru;Nakajima, Isao;Hata, Jun-ichi;Ta, Masuhisa
    • Journal of Multimedia Information System
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    • 제5권2호
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    • pp.91-98
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    • 2018
  • We devised a bird-borne transceiver unit for S-band packet radio communications based on the CC2500 transceiver, a device manufactured by Texas Instruments (TI). Our assessments determined the optimal parameters needed to achieve successful bird-to-center communication over a distance of 18 km and bird-to-bird communication over a distance of 200 m. These parameters included optimal modulation methods, transmission rates, and antennas. We equipped the transceiver unit with a modified dipole antenna (collinear antenna), which we tested in a 10 m anechoic chamber. Our experimental assessments and circuit design review identified the following parameters: 2FSK modulation method; 14.28 kHz frequency shift; 101.56 kHz IF reception bandwidth; and Manchester encoding (+). Our assessments showed bird-to-bird communications could be achieved over a distance of 200 m assuming MSK, FEC (+), and 500 kbps. Following tests by an official body, we obtained 28 sets of a type approval license for 2.4 GHz. In cooperation with the Yamashina Institute for Ornithology, we attempted to tag and release six or more swans. This unit gives us the ability to obtain vital data on swans. We expect this data to provide significant benefits, including clues on improving screening for infected individuals.

한약제제, 생약제제와 천연물신약의 법규상 개념 및 정의의 문제점과 개선안 (A study on the Problems and Improvement Proposals on Legal Definitions in Respect of Herbal Medicinal Preparations, Crude Drug Preparations and New Drugs from Natural Products)

  • 엄석기
    • 대한한의학원전학회지
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    • 제27권4호
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    • pp.181-198
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    • 2014
  • Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.