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Bulletin of National Institute of Health Sciences最新文献

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[Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products]. 【NIHS对再生医学和细胞治疗产品的转化/调控科学研究】。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Yoji Sato
{"title":"[Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].","authors":"Yoji Sato","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the TPA, a product derived from processing cells is categorized as a subgroup of \"regenerative medicine, cellular therapy and gene therapy products\" (RCGPs), products distinct from pharmaceuticals and medical devices, allowing RCGPs to obtain a conditional and time- limited marketing authorization much earlier than that under the conventional system. To foster not only RCGPs, but also innovative pharmaceuticals and medical devices, the Ministry of Health, Labour and Welfare recently launched Translational Research Program for Innovative Pharmaceuticals, Medical Devices and RCGPs. This mini-review introduces contributions of the National Institute of Health Sciences (NIHS) to research projects on RCGPs in the Program.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"6-9"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Activity report on a programe of the Ministry of Health, Labour and Welfare (MHLW) "Initiative to facilitate development of innovative drugs, medical devices, and cellular and tissue-based products" in National Institute of Health Sciences]. [关于卫生、劳动和福利部(MHLW)方案的活动报告]“促进创新药物、医疗设备、细胞和组织产品开发的倡议”(国家健康科学研究所)。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
{"title":"[Activity report on a programe of the Ministry of Health, Labour and Welfare (MHLW) \"Initiative to facilitate development of innovative drugs, medical devices, and cellular and tissue-based products\" in National Institute of Health Sciences].","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Immunotoxicity and environmental substances]. [免疫毒性和环境物质]。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Reiko Teshima
{"title":"[Immunotoxicity and environmental substances].","authors":"Reiko Teshima","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A well functioning immune system is essential in maintaining integrity of the organism, and malfunction may have severe health consequences. Environmental substances may pose direct toxicity to components of the immune system, often leading to immunosuppression and resulting reduced resistance to infections and tumors. Alternatively, such substances may be recognized by the immune system in a specific fashion, which may result in allergy and autoimmunity. A proper risk assessment of environmental substances in terms of immunotoxicity is necessary. In this manuscript, I reviewed recent three topics about immunotoxicity: (1) IPCS/WHO Guidance for immunotoxicity risk assessment for chemicals, (2) Intestinal immunotoxicity, and (3) Epicutaneous sensitization of food proteins.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"47-56"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo]. [加速创新医疗设备实际应用的项目，与TWIns、早稻田大学高级生物医学科学中心和东京大学工程学院合作]。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Shingo Niimi, Mitsuo Umezu, Hiroshi Iseki, Hiroshi Kasanuki Noboru Harada, Mamoru Mitsuishi, Takehiko Kitamori, Yuichi Tei, Ryusuke Nakaoka, Yuji Haishima
{"title":"[Projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo].","authors":"Shingo Niimi,&nbsp;Mitsuo Umezu,&nbsp;Hiroshi Iseki,&nbsp;Hiroshi Kasanuki Noboru Harada,&nbsp;Mamoru Mitsuishi,&nbsp;Takehiko Kitamori,&nbsp;Yuichi Tei,&nbsp;Ryusuke Nakaoka,&nbsp;Yuji Haishima","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Division of Medical Devices has been conducting the projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo. The TWIns has been studying to aim at establishment of preclinical evaluation methods by \"Engineering Based Medicine\", and established Regulatory Science Institute for Medical Devices. School of Engineering, The University of Tokyo has been studying to aim at establishment of assessment methodology for innovative minimally invasive therapeutic devices, materials, and nanobio diagnostic devices. This report reviews the exchanges of personnel, the implement systems and the research progress of these projects.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"16-8"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Accession to the PIC/S and pharmaceutical quality system in Japan]. 【加入日本PIC/S和药品质量体系】。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Noriko Katori
{"title":"[Accession to the PIC/S and pharmaceutical quality system in Japan].","authors":"Noriko Katori","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In March, 2012, Japan made the application for membership of the Pharmaceutical Inspection convention and Pharmaceutical Inspection Co-operation scheme (PIC/S) which is an international body of a GMP inspection. The globalization of pharmaceutical manufacturing and sales has been a driving force behind the decision to become a PIC/S member. For the application for membership, Japan's GMP inspectorate needs to fulfill PIC/S requirements, for example, the inspection organization has to have a quality system as a global standard. One of the other requirements is that the GMP inspectorate can access Official Medicines Control Laboratories (OMCL) having high analytical skills and also have a quality system based on ISO 17025. I would like to describe the process to make up a quality system in the National Institute of Health Sciences and also the circumstances around the PIC/S application in Japan.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"22-35"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Examination of identification test of certain aromatic amines originating from azo colorants in textile and leather products using high performance liquid chromatography]. [用高效液相色谱法检查纺织品和皮革制品中偶氮染料中某些芳香胺的鉴定试验]。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Tsuyoshi Kawakami, Kazuo Isama, Yoshiaki Ikarashi
{"title":"[Examination of identification test of certain aromatic amines originating from azo colorants in textile and leather products using high performance liquid chromatography].","authors":"Tsuyoshi Kawakami,&nbsp;Kazuo Isama,&nbsp;Yoshiaki Ikarashi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Azo colorants that generate primary aromatic amines (PAAs) have been recently deliberated as a controlled harmful substance by the \"Act on the Control of Household Products Containing Harmful Substances\" in Japan. Therefore, we examined an identification test for 22 kinds of PAAs originating from the azo colorants in commercial textile products and leather products using high performance liquid chromatography (HPLC). When a PAAs standard solution containing 2,4-xylidine and 2,6-xylidine was analyzed using the condition according to EN14362-1:2012 at 240 nm as a basic condition, we observed enough separation for all the PAAs to identify. However, in the some sample solutions, the peaks of several PAAs were overlapped with the interference peaks, and their identifications were difficult. In these cases, some PAAs were able to identify by alteration to suitable wavelength. Furthermore, the retention time of almost PAAs and interference peaks were changed by using acetonitrile as the organic solvent in eluent or phenyl type column. These modifications were helpful for identification of PAA which was overlapped to interference substances by the basic condition. Thus, we suggest the HPLC condition for an identification test is in accordance to that described in EN14362-1:2013. And we propose that the HPLC condition can be modified as necessary.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"57-66"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases]. [促进基因疾病基因治疗产品临床开发的监管科学合作研究]。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Eriko Uchida, Yuka Igarashi, Yoji Sato
{"title":"[Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases].","authors":"Eriko Uchida,&nbsp;Yuka Igarashi,&nbsp;Yoji Sato","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Gene therapy products are expected as innovative medicinal products for intractable diseases such as life-threatening genetic diseases and cancer. Recently, clinical developments by pharmaceutical companies are accelerated in Europe and the United States, and the first gene therapy product in advanced countries was approved for marketing authorization by the European Commission in 2012. On the other hand, more than 40 clinical studies for gene therapy have been completed or ongoing in Japan, most of them are conducted as clinical researches by academic institutes, and few clinical trials have been conducted for approval of gene therapy products. In order to promote the development of gene therapy products, revision of the current guideline and/or preparation of concept paper to address the evaluation of the quality and safety of gene therapy products are necessary and desired to clearly show what data should be submitted before First-in-Human clinical trials of novel gene therapy products. We started collaborative study with academia and regulatory agency to promote regulatory science toward clinical development of gene therapy products for genetic diseases based on lentivirus and adeno-associated virus vectors; National Center for Child Health and Development (NCCHD), Nippon Medical School and PMDA have been joined in the task force. At first, we are preparing pre-draft of the revision of the current gene therapy guidelines in this project.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"10-2"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Regulatory science researches of nanomedicines]. [纳米药物调控科学研究]。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Kumiko Sakai-Kato, Yukihiro Goda
{"title":"[Regulatory science researches of nanomedicines].","authors":"Kumiko Sakai-Kato,&nbsp;Yukihiro Goda","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Recently, the development of nanomedicines is progressing. These are designed to ensure high stability and to optimize the pharmacokinetics in vivo. The polymeric micelles and lipid nanoparticles are typical such examples. Because the unique size-specific interaction with biological systems or biodistribution may have significant impacts on the efficacy and safety of nanomedicines, regulatory science researches of nanomedicines are required. In this review, the authors introduce our initiatives of the regulatory science researches of nanomedicines.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"3-5"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Current situations and the future prospect of monoclonal antibody products]. 【单克隆抗体产品的现状及未来展望】。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Teruhide Yamaguchi
{"title":"[Current situations and the future prospect of monoclonal antibody products].","authors":"Teruhide Yamaguchi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Monoclonal antibody products and monoclonal antibody-based biopharmaceuticals have shown considerable effectiveness in the treatment for variety of diseases; cancer, auto-immune/auto-inflammation diseases and so on. Significant advance in monoclonal antibody products for cancer treatments was made with antibody-drug conjugates (ADC), and antibodies for blockade of immune checkpoints. Already 3 ADCs and 2 anti-immune-checkpoint antibodies products have been approved, and these monoclonal antibody-related product pipelines reach over 30. On the other hand, EU approved first monoclonal-antibody biosimilar, RemsimaTM (infliximab), suggesting that other monoclonal-antibody biosmilars will follow to the market. In this paper, several new issues about monoclonal antibody products will be discussed.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"36-46"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Development of identification method for isopropyl citrate]. [柠檬酸异丙酯鉴定方法的发展]。
Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Noriko Furusho, Takashi Ohtsuki, Chiye Tatebe-Sasaki, Hiroki Kubota, Kyoko Sato, Hiroshi Akiyama
{"title":"[Development of identification method for isopropyl citrate].","authors":"Noriko Furusho,&nbsp;Takashi Ohtsuki,&nbsp;Chiye Tatebe-Sasaki,&nbsp;Hiroki Kubota,&nbsp;Kyoko Sato,&nbsp;Hiroshi Akiyama","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In Japan's Specification and Standards for Food Additive, 8th edition, two identification tests involving isopropyl citrate for detecting isopropyl alcohol and citrate are stipulated. However, these identification tests use mercury compound, which is toxic, or require a time-consuming pretreatment process. To solve these problems, an identification test method using GC-FID for detecting isopropyl alcohol was developed. In this test, a good linearity was observed in the range of 0.1-40 mg/mL of isopropyl alcohol. While investigating the pretreatment process, we found that isopropyl alcohol could be detected using GC-FID in the distillation step only, without involving any reflux step. The study also showed that the citrate moiety of isopropyl citrate was identified using the solution remaining after conducting the distillation of isopropyl alcohol. The developed identification tests for isopropyl citrate are simple and use no toxic materials.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 132","pages":"67-71"},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33077915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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