• Title/Summary/Keyword: safety efficacy

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Efficacy of Listeria Innocua Reduction on Enoki Mushrooms by Utilization of an Air Sterilization Device (공기 살균 장치 적용 팽이버섯 재배사의 Listeria Innocua 저감 효과)

  • Lee, Hyun-Dong;Yu, Byeong-Kee;Seo, Da-Som;Kim, Se-Ri;Lee, Chan-Jung;Kwak, Kang-Su
    • Journal of Mushroom
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    • v.19 no.3
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    • pp.210-215
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    • 2021
  • For sterilization of microorganisms of the Listeria genus contaminating enoki mushroom, pilot mushroom grower equipped with air sterilization devices were developed. Sterilization experiments were performed using physical and chemical treatments. Internal temperature and humidity were controlled, maintaining 6.62℃±0.30 in the upper shelves, 6.46℃±0.24 in the middle shelves, and 6.48℃±0.25 in the lower shelves. Humidities were 79.97%±4.42, 79.43%±4.06, and 79.94±4.30%, respectively, with a temperature setting of 6.5℃, and a relative humidity of 75%. A suitable enoki mushroom cultivation stage for air sterilizer application was during the growth stage, with temperature in the 6.5~8.5℃ range, and humidity of 70~80%. At these same internal conditions, the ozone concentration in the mushroom cultivator was found to be 160 ppb during ion-cluster generator operation. After physical sterilization, the Listeria innocua survival rate was 0.1 to 0.9% using ion cluster sterilization, and 9.3 to 10.6% using UV air sterilization. The Listeria innocua survival rates on different materials were 9.3~10.6% on the metal specimen, and 9.9~16.2% on the plastic wrapper. The survival rate was particularly high on the rough side of the plastic wrapper. Ion cluster air sterilization is a labor-saving and effective method for suppressing the occurrence of Listeria bacteria on mushroom growers walls and shelves. For the plastic wrapper, chemical sterilization is more effective than physical sterilization.

The Tumor Control According to Radiation Dose of Gamma Knife Radiosurgery for Small and Medium-Sized Brain Metastases from Non-Small Cell Lung Cancer

  • Park, Sue Jee;Lim, Sa-Hoe;Kim, Young-Jin;Moon, Kyung-Sub;Kim, In-Young;Jung, Shin;Kim, Seul-Kee;Oh, In-Jae;Hong, Jong-Hwan;Jung, Tae-Young
    • Journal of Korean Neurosurgical Society
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    • v.64 no.6
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    • pp.983-994
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    • 2021
  • Objective : The effectiveness of gamma knife radiosurgery (GKR) in the treatment of brain metastases is well established. The aim of this study was to evaluate the efficacy and safety of maximizing the radiation dose in GKR and the factors influencing tumor control in cases of small and medium-sized brain metastases from non-small cell lung cancer (NSCLC). Methods : We analyzed 230 metastatic brain tumors less than 5 mL in volume in 146 patients with NSCLC who underwent GKR. The patients had no previous radiation therapy for brain metastases. The pathologies of the tumors were adenocarcinoma (n=207), squamous cell carcinoma (n=18), and others (n=5). The radiation doses were classified as 18, 20, 22, and 24 Gy, and based on the tumor volume, the tumors were categorized as follows : small-sized (less than 1 mL) and medium-sized (1-3 and 3-5 mL). The progression-free survival (PFS) of the individual 230 tumors and 146 brain metastases was evaluated after GKR depending on the pathology, Eastern Cooperative Oncology Group (ECOG) performance score (PS), tumor volume, radiation dose, and anti-cancer regimens. The radiotoxicity after GKR was also evaluated. Results : After GKR, the restricted mean PFS of individual 230 tumors at 24 months was 15.6 months (14.0-17.1). In small-sized tumors, as the dose of radiation increased, the tumor control rates tended to increase (p=0.072). In medium-sized tumors, there was no statistically difference in PFS with an increase of radiation dose (p=0.783). On univariate analyses, a statistically significant increase in PFS was associated with adenocarcinomas (p=0.001), tumors with ECOG PS 0 (p=0.005), small-sized tumors (p=0.003), radiation dose of 24 Gy (p=0.014), synchronous lesions (p=0.002), and targeted therapy (p=0.004). On multivariate analyses, an improved PFS was seen with targeted therapy (hazard ratio, 0.356; 95% confidence interval, 0.150-0.842; p=0.019). After GKR, the restricted mean PFS of brain at 24 months was 9.8 months (8.5-11.1) in 146 patients, and the pattern of recurrence was mostly distant within the brain (66.4%). The small and medium-sized tumors treated with GKR showed radiotoxicitiy in five out of 230 tumors (2.2%), which were controlled with medical treatment. Conclusion : The small-sized tumors were effectively controlled without symptomatic radiation necrosis as the radiation dose was increased up to 24 Gy. The medium-sized tumors showed potential for symptomatic radiation necrosis without signifcant tumor control rate, when greater than 18 Gy. GKR combined targeted therapy improved the tumor control of GKR-treated tumors.

"The U.S. military uses ginseng?": The official entrance of ginseng to the U.S. dietary supplement market and the U. S. military's dietary supplement manual in the late 20th century ("미군의 인삼 복용?" : 20세기 말 인삼의 미국 식이보충제 시장 편입과 미군 매뉴얼)

  • Seok, Yeong-dal
    • Journal of Ginseng Culture
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    • v.1
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    • pp.93-109
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    • 2019
  • This study aims to look at the process of ginseng being removed from the Western pharmacopoeia in the 19th century, experiencing a crisis as an export product in the America in the 20th century, and eventually settling in the U.S. society and the military as a dietary supplement in the 21th century. In this process, the legislation of provided a bridgehead for ginseng and other botanical dietary supplements to enter the U.S. market. As a result, ginseng could be re-listed in the U.S. pharmacopoeia as a dietary supplement. However, this did not mean a complete soft landing of ginseng and other botanical dietary supplements in the America. The U.S. medical community, which has been afraid of the indiscriminate spread of botanical dietary supplements, has constantly raised "the risk-discourse" and expressed concerns over the use and abuse of botanical dietary supplements that have not been scientifically verified. This involved not only the fundamental problems caused by the lax verification process of , but also a new atmosphere in the U.S. where the public sought information about botanical dietary supplements rather than seeking professional clinicians related to their health. Against this situation, "the advocate-discourse" suggested by dietary supplement manufacturers and the people in charge of botanical products seemed rather relaxed. As consumers are taking this side, the advocates had only to stress that botanical dietary supplements have been used worldwide for a long time without any problems and were made from 'natural' materials. The fact that ginseng and other botanical dietary supplements were able to advance to the U.S. Military's dietary supplement manual, which is strict in controlling food, seems to have jumped on the bandwagon of this atmosphere in the U.S. Society. In the early U.S. dietary supplement manual reviewed in this paper, ginseng was the most detailed among many botanical dietary supplements. Although there are some 'safety concerns' that still exist in the civilian society, but there are also certainly good scientific explanations for the efficacy and references to the popularity and influence of ginseng in the American society. Given this, the U.S. society and military's interest in ginseng as a dietary supplement seem quite high.

Analysis of Physical Status on COVID-19: Based on Impacts of Physical Activity (COVID-19에 대한 운동중재효과 분석)

  • Kim, Kwi-Baek;Kwak, Yi Sub
    • Journal of Life Science
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    • v.31 no.6
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    • pp.603-608
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    • 2021
  • The purpose of this perspective research is to discuss the potential role of exercise-interventions in COVID-19, terms of prevention and prognosis in the periods of the COVID-19 vaccine. SARCO-CoV-2. COVID-19 was detected as a new virus causing severe cardiovascular and respiratory complications. It emerged as a global public health emergency and national pandemic. It caused more than 1 million deaths in the first 6 months of the pandemic and resulted in huge social and economic fluctuations internationally. Unprecedented stressful situations, such as COVID-19 blue and COVID-19 red impact on many health problems. In healthy individuals, COVID-19 infection may induced no symptoms (i.e., asymptomatic), whereas others may experience flu-like symptoms, such as ARDS, pneumonia, and death. Poor health status, such as obesity and cardiovascular and respiratory complications, are high risk factors for COVID-19 prevention, occurrence, and prognosis. Several COVID-19 vaccines are currently in human trials. However, the efficacy and safety of COVID-19 vaccines, including potential side effects, such as anaphylaxis (a life-threatening allergic reaction) and rare blood clots, still need to be investigated. On the basis of direct and indirect evidence, it seems that regular and moderate physical exercise can be recommended as a nonpharmacological, efficient, and safe way to cope with COVID-19. Physical inactivity and metabolic abnormalities are directly associated with reduced immune responses, including reduced innate, CMI, and AMI responses. Due to prolonged viral shedding, quarantine in inactive, obese and disease people should likely be longer than physical active people. Multicomponent and systemic exercise should be considered for the obese, disease, and elderly people. More mechanism research is needed in this area.

New Functional Properties of Passion Fruit Extract on Skin (패션 프룻 추출물이 피부에 미치는 새로운 기능적 효과)

  • Jeong, Mi Suk;Kim, Soon-Rae;Han, Chang Woo;Kim, Hyeon Jin;Jang, Se Bok
    • Journal of Life Science
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    • v.32 no.2
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    • pp.101-107
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    • 2022
  • In this research, the anti-inflammatory, antioxidant, antiaging, and skin whitening properties of pulp and seed extracts of passion fruit were studied. The result of the primary skin irritation test using a skin-attached patch determined the skin irritation index to be 0.00 for the passion fruit extract. In addition, RAW 264.7 macrophages produce NO by stimulation of lipopolysaccharides, and the application of extracts to this resulted in significantly lower NOs, confirming the excellent anti-inflammatory properties of passion fruit extracts. The 2,2-diphenyl-1-picrylhydrazyl test further confirmed that the passion fruit extract exhibits a good 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonate radical scavenging ability of 5.11% and strong antioxidant properties. The presence of collagen type I in the skin is a measure of aging and various skin diseases. The results obtained from the analysis of the activity of human procollagen I alpha 1 confirmed that the passion fruit extract reduces the synthesis of procollagen. In addition, the skin whitening property of the passion fruit extract was confirmed by the melanin inhibition test, and a sample was obtained that contained more than 2% of arbutin, a whitening agent approved by the Ministry of Food and Drug Safety, which is generally present in the form of a white powder and is used as a functional ingredient. This confirms that the whitening efficacy of the passion fruit extract obtained from nature contributes to the development of functional raw materials for cosmetics and food.

Preparation of an Inactivated Influenza Vaccine Using the Ethanol Extracts of Medical Herbs (한약재 식물 에탄올추출물을 이용한 인플루엔자 불활화백신 제작)

  • Cho, Sehee;Lee, Seung-Hoon;Kim, Seonjeong;Cheong, Yucheol;Kim, Yewon;Kim, Ju Won;Kim, Su Jeong;Seo, Seungin;Seo, Dong-Won;Lim, Jae-Hwan;Jeon, Sejin;Jang, Yo Han
    • Journal of Life Science
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    • v.32 no.12
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    • pp.919-928
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    • 2022
  • As seen in the COVID-19 pandemic, unexpected emergence of new viruses presents serious concern on public health. Especially, the absence of effective vaccines or antiviral drugs against emerging viruses significantly increases the severity of disease and duration of viral circulation among population. Natural products have served as a major source for safe and effective antiviral drugs. In this study, we examined the virucidal activity of medical herb extracts with a view to discover novel antiviral agents with desired levels of safety and antiviral efficacy. Ethanol extracts of ten selected medical herbs were tested for antioxidant activity and in-vitro cytotoxicity in various animal cell lines. Of note, the herbal extracts showed broad and potent virucidal activities against rotavirus, hepatitis A virus, and influenza A virus. The extracts of Sorbus commixta and Glycyrrhiza uralensis showed strong virucidal activities against influenza A virus. We also examined whether the extracts of Sorbus commixta and Glycyrrhiza uralensis can be used as inactivating agents to prepare an inactivated viral vaccine. In a mouse model, influenza A virus inactivated by the extracts elicited high levels of neutralizing antibodies, and the vaccination provided complete protection against lethal challenge. These results suggest that herb-derived natural products can be developed to antiviral drugs as well as inactivating agents for preparation of inactivated viral vaccines.

A Study on the Countermeasures Taken By the Korean Healthcare and Life Sciences Industry Regarding U.S. Import Refusals: Focus on the Analysis of FDA Violation Codes (한국 바이오헬스 산업의 미국 수입거부 대응 방안 연구 : FDA 위반코드 분석을 중심으로)

  • Yu-Han Lee;Hag-Min Kim
    • Korea Trade Review
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    • v.48 no.3
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    • pp.131-150
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    • 2023
  • The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).

Early Clinical Experience in Aortic Valve Replacement Using On-X$^{circledR}$Prosthetic Heart Valve (On-X$^{circledR}$ 기계판막을 이용한 대동맥판 치환술의 조기 임상 경험)

  • 안병희;전준경;류상완;최용선;김병표;홍성범;박종춘;김상형
    • Journal of Chest Surgery
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    • v.36 no.9
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    • pp.651-658
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    • 2003
  • Since the first implanted in September 1997, the use of On-X prosthetic heart valve has been increasing around in the world. This study was designed to assess the feasibility, safety, and the postoperative hemodynamics with this new valve in clinical setting. Material and Method: The current study was carried out on 52 patients undergoing aortic valve replacement with this prosthesis between April 1999 to August 2002 at Chonnam National University Hospital to evaluate the surgical results. 52% of the patients were male and the average age at implant was 50$\pm$13 years. The study followed the guidelines of the AATS/STS. Preoperatively, 32(61.5%) patients were in NYHA functional class III or IV and 2 patients had previous aortic valve surgery. Concomitant cardiac surgery was performed in 71.1%. The implanted valve sizes were 19 mm in 13 patients, 21 mm in 26, 23 mm in 10 and 25 mm in 3, respectively. Mean follow-up was 16.6$\pm$10.5 months (1∼39 months). Echocardiographic assessment was performed pre- and immediate postoperatively, as well as 3, 6, 12 months after surgery, evaluating pressure loss and regression of left ventricular hypertrophy. Result: Mean cardiopulmonary bypass time was 191$\pm$94.7 minutes with an aortic cross-clamp time of 142$\pm$51.7 minutes. There was no early and late mortality, Freedom from adverse events at 1 year in the study were as follows: thromboembolism, 95.6$\pm$6%; bleeding events, 90.2$\pm$4%; paravalvular leakage 92.3$\pm$4%; and overall valve-related morbidity at 1 year was 76.6$\pm$3%. There were no cases of valve thrombosis, prosthetic valve endocarditis and structural or non-structural failure. Left ventricular function at 12 months after surgery (EF=62.7$\pm$9.8%) revealed a statistically significant improvement compared to preoperative investigation (EF=55.8$\pm$15.9%, p=0.006). Left ventricular mass index was 247.3$\pm$122.3 g/$m^2$ on preoperative echocardiographic study, but regressed to 155.5$\pm$58.2 g/$m^2$ at postoperative 1 year (p=0.002). Over the follow-up period a further decrease of peak transvalvular gradients was observed in all patients: 62.5$\pm$38.0 mmHg on preoperative assessment, 18.2$\pm$6.8 mmHg at immediate postoperative period (p < 0.0001), 7.6$\pm$5.09 mmHg (p<0.0001) at 6 month, 18.0$\pm$10.8 mmHg (p<0.0001) at 1 year. Conclusion: The On-X prosthetic heart valve performs satisfactorily in the first 1 year period. Clinical outcome by examining NYHA functional classification revealed especially good results. Effective regression of left ventricular hypertrophy and statistically significant decrease of transvalvular gradient were observed over the first year, but longer-term follow-up of this patient group is needed to establish the expected rates for late valve-related events as well as the long-term clinical efficacy of this valve.

The Cox-Maze Procedure for Atrial Fibrillation Concomitant with Mitral Valve Disease (승모판막질환에 동반된 심방세동에서 Cox-Maze 술식)

  • Kim, Ki-Bong;Cho, Kwang-Ree;Ahn, Hyuk
    • Journal of Chest Surgery
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    • v.31 no.10
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    • pp.939-944
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    • 1998
  • Background: The sugical results of the Cox-Maze procedure (CMP) for lone atrial fibrillation(AF) have proven to be exellent. However, those for AF associated with mitral valve(MV) disease have been reported to be a little inferior. Materials and methods: To assess the efficacy and safety of the CMP as a combined procedure with MV operation, we studied retrospectively our experiences. Between April 1994 and October 1997, we experienced 70 (23 males, 47 females) cases of CMP concomitantly with MV operation. Results: The etiologies of MV disease were rheumatic in 67 and degenerative in 3 cases. The mean duration of AF before sugery was 66$\pm$70 months. Fifteen patients had the past medical history of thromboembolic complications, and left atrial thrombi were identified at operation in 24 patients. Twelve cases were reoperations. Aortic cross clamp (ACC) time was mean 151$\pm$44 minutes, and cardiopulmonary bypass (CPB) time was mean 246$\pm$65 minutes. Concomitant procedures were mitral valve replacement (MVR) in 19, MVR and aortic valve replacement (AVR) in 14, MVR and tricupid annuloplasty (TAP) in 8, MVR with AV repair in 3, MV repair in 11, MVR and coronary artery bypass grafting (CABG) in 2, MVR and AVR and CABG in 1, redo-MVR in 10, redo-MVR and redo-AVR in 2 patients. The rate of hospital mortality was 1.4%(1/70). Perioperative recurrence of AF was seen in 44(62.9%), and atrial tachyarrhythmias in 10(14.3%), low cardiac output syndrome in 4(5.7%), postoperative bleeding that required mediastinal exploration in 4(5.7%) patients. Other complications were acute renal failure in 2, aggravation of preoperative hemiplegia in 1, and transient delirium in 1 patient. We followed up all the survivors for 16.4 months(3-44months) on an average. Sinus rhythm has been restored in 65(94.2%) patients. AF has been controlled by operation alone in 73.9% and operation plus medication in 20.3%. Two patients needed permanent pacemaker implantation; one with sick sinus syndrome, and the other with tachycardia- bradycardia syndrome. Only two patients remained in AF. We followed up our patients with transthoracic echocardiography to assess the atrial contractilities and other cardiac functions. Right atrial contractility could be demonstrated in 92% and left atrial contractility in 53%.We compared our non-redo cases with redo cases. Although the duration of AF was significantly longer in redo cases, there was no differences in ACC time, CPB time, postoperative bleeding amount and sinus conversion rate. Conclusions: In conclusion, the CMP concomitant with MV operation demonstrated a high sinus conversion rate under the acceptable operative risk even in case of reoperation.

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Global Cosmetics Trends and Cosmceuticals for 21st Century Asia (화장품의 세계적인 개발동향과 21세기 아시아인을 위한 기능성 화장품)

  • T.Joseph Lin
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.23 no.1
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    • pp.5-20
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    • 1997
  • War and poverty depress the consumption of cosmetics, while peace and prosperity encourage their proliferation. With the end of World War II, the US, Europe and Japan witnessed rapid growth of their cosmetic industries. The ending of the Cold War has stimulated the growth of the industry in Eastern Europe. Improved economies, and mass communication are also responsible for the fast growth of the cosmetic industries in many Asian nations. The rapid development of the cosmetic industry in mainland China over the past decade proves that changing economies and political climates can deeply affect the health of our business. In addition to war, economy, political climate and mass communication, factors such as lifestyle, religion, morality and value concepts, can also affect the growth of our industry. Cosmetics are the product of the society. As society and the needs of its people change, cosmetics also evolve with respect to their contents, packaging, distribution, marketing concepts, and emphasis. In many ways, cosmetics mirror our society, reflecting social changes. Until the early 70's, cosmetics in the US were primarily developed for white women. The civil rights movement of the 60's gave birth to ethnic cosmetics, and products designed for African-Americans became popular in the 70's and 80's. The consumerism of the 70's led the FDA to tighten cosmetic regulations, forcing manufacturers to disclose ingredients on their labels. The result was the spread of safety-oriented, "hypoallergenic" cosmetics and more selective use of ingredients. The new ingredient labeling law in Europe is also likely to affect the manner in which development chemists choose ingredients for new products. Environmental pollution, too, can affect cosmetics trends. For example, the concern over ozone depletion in the stratosphere has promoted the consumption of suncare products. Similarly, the popularity of natural cosmetic ingredients, the search of non-animal testing methods, and ecology-conscious cosmetic packaging seen in recent years all reflect the profound influences of our changing world. In the 1980's, a class of efficacy-oriented skin-care products, which the New York Times dubbed "serious" cosmetics, emerged in the US. "Cosmeceuticals" refer to hybrids of cosmetics and pharmaceuticals which have gained importance in the US in the 90's and are quickly spreading world-wide. In spite of regulatory problems, consumer demand and new technologies continue to encourage their development. New classes of cosmeceuticals are emerging to meet the demands of increasingly affluent Asian consumers as we enter the 21st century. as we enter the 21st century.

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