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Last Updated :2024/07/25

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Master

Affiliation (Master)

  • Hokkaido University Hospital

Affiliation (Master)

  • Hokkaido University Hospital

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Profile and Settings

Degree

  • Ph.D.（The University of Tokyo）

Profile and Settings

  • Name (Japanese)

    ARATO

  • Name (Kana)

    Teruyo

  • Name

    201301056474393042

Alternate Names

Achievement

Research Interests

  • サイクリンD1   p27   角膜上皮創傷治癒   PCNA   細胞増殖   ラット角膜上皮創傷モデル   角膜輪部   G1サイクリン   幹細胞   細胞周期調節タンパク質   サイクリンE   上皮基底細胞   

Research Areas

  • Life sciences / Ophthalmology

Research Experience

  • 1997 - 1998 Kyorin University Faculty of Medicine

Published Papers

  • Mohamed Farid, Jianfei Cao, Yeongjoo Lim, Teruyo Arato, Kota Kodama
    International Journal of Environmental Research and Public Health 17 (8) 1661-7827 2020/04 [Refereed][Not invited]
     
    © 2020 by the authors. Licensee MDPI, Basel, Switzerland. Genetically edited food utilizes new techniques that may decrease all of the risks associated with genetically modified food, or “GMO” food. Safety and labeling regulations for genetically edited food are still new, and it is challenging for the consumer to differentiate it from conventional food. Although genetically edited food has the potential for reducing the risks associated with the gene introduction process, consumer perceptions toward it are still unclear. The research has compared the regulations governing GMO food and genetically edited food in Japan, Europe, and the United States. We found that the genetically edited food regulations in Japan are the most science-based, in the meaning that genetically edited food products are allowed to be sold without any safety evaluation. Based on the difference among regions, we further studied the potential acceptance level for such products among Japanese consumers, where regulation seemed science-based as policy. To understand the factors that may affect the adoption of genetically edited food among youth in Japan, we utilized the structural equation modeling (SEM) method with 180 surveys of Japanese university students to measure six factors: Knowledge, Attitude Towards Technology, Perceived Benefits, Perceived Risks, Trust, and Willingness to Purchase. The survey was conducted twice with an intervention in the middle to measure the effect of science communication, and we found significant differences when comparing the two datasets. The results of this survey indicate the importance of increasing knowledge and the positive role of science communication in increasing the adoption and trust of biotechnology products, such as genetically edited food.
  • 荒戸 照世, 仙石 愼太郎
    Global Journal of Health Science 印刷中 2019 [Refereed]
  • Houkin K, Shichinohe H, Abe K, Arato T, Dezawa M, Honmou O, Horie N, Katayama Y, Kudo K, Kuroda S, Matsuyama T, Miyai I, Nagata I, Niizuma K, Sakushima K, Sasaki M, Sato N, Sawanobori K, Suda S, Taguchi A, Tominaga T, Yamamoto H, Yamashita T, Yoshimine T, Working Group, for Guidelines on Development of Cell-Based, Products for the Treatment of Cerebral Infarction
    Stroke 49 (4) e145 - e152 0039-2499 2018/04 [Refereed][Not invited]
  • 荒戸照世
    月刊腫瘍内科 20 (5) 528‐532  1881-6568 2017/11/28 [Not refereed][Not invited]
  • Hideo Shichinohe, Masahito Kawabori, Hiroaki Iijima, Tuyoshi Teramoto, Takeo Abumiya, Naoki Nakayama, Ken Kazumata, Shunsuke Terasaka, Teruyo Arato, Kiyohiro Houkin
    BMC NEUROLOGY 17 (1) 179  1471-2377 2017/09 [Refereed][Not invited]
     
    Background: Stroke is a leading cause of death and disability, and despite intensive research, few treatment options exist. However, a recent breakthrough in cell therapy is expected to reverse the neurological sequelae of stroke. Although some pioneer studies on the use of cell therapy for treating stroke have been reported, certain problems remain unsolved. Recent studies have demonstrated that bone marrow stromal cells (BMSCs) have therapeutic potential against stroke. We investigated the use of autologous BMSC transplantation as a next-generation cell therapy for treating stroke. In this article, we introduce the protocol of a new clinical trial, the Research on Advanced Intervention using Novel Bone marrOW stem cell (RAINBOW). Methods/design: RAINBOW is a phase 1, open-label, uncontrolled, dose-response study, with the primary aim to determine the safety of the autologous BMSC product HUNS001-01 when administered to patients with acute ischemic stroke. Estimated enrollment is 6-10 patients suffering from moderate to severe neurological deficits. Approximately 50 mL of the bone marrow is extracted from the iliac bone of each patient 15 days or later from the onset. BMSCs are cultured with allogeneic human platelet lysate (PL) as a substitute for fetal calf serum and are labeled with superparamagnetic iron oxide for cell tracking using magnetic resonance imaging (MRI). HUNS00101 is stereotactically administered around the area of infarction in the subacute phase. Each patient will be administered a dose of 20 or 50 million cells. Neurological scoring, MRI for cell tracking, F-18-fuorodeoxyglucose positron emission tomography, and I-123-Iomazenil singlephoton emission computed tomography will be performed for 1 year after the administration. Discussion: This is a first-in-human trial for HUNS001-01 to the patients with acute ischemic stroke. We expect that intraparenchymal injection can be a more favorable method for cell delivery to the lesion and improvement of the motor function than intravenous infusion. Moreover, it is expected that the bio-imaging techniques can clarify the therapeutic mechanisms.
  • Kojiro Maeda, Masayuki Kaneko, Mamoru Narukawa, Teruyo Arato
    ORPHANET JOURNAL OF RARE DISEASES 12 (1) 143  1750-1172 2017/08 [Refereed][Not invited]
     
    Background: The unmet medical needs of individuals with very rare diseases are high. The clinical trial designs and evaluation methods used for 'regular' drugs are not applicable in the clinical development of ultra-orphan drugs (<1000 patients) in many cases. In order to improve the clinical development of ultra-orphan drugs, we examined several points regarding the efficient evaluations of drug efficacy and safety that could be conducted even with very small sample sizes, based on the review reports of orphan drugs approved in Japan. Results: The clinical data packages of 43 ultra-orphan drugs approved in Japan from January 2001 to December 2014 were investigated. Japanese clinical trial data were not included in the clinical data package for eight ultra-orphan drugs, and non-Japanese clinical trial data were included for six of these eight drug. Japanese supportive data that included retrospective studies, published literature, clinical research and Japanese survey results were clinical data package attachments in 22 of the 43 ultra-orphan drugs. Multinational trials were conducted for three ultra-orphan drugs. More than two randomized controlled trials (RCTs) were conducted for only 11 of the 43 ultra-orphan drugs. The smaller the number of patients, the greater the proportion of forced titration and optional titration trials were conducted. Extension trials were carried out for enzyme preparations and monoclonal antibodies with high ratio. Post-marketing surveillance of all patients was required in 36 of the 43 ultra-orphan drugs. For ultra-orphan drugs, clinical endpoints were used as the primary efficacy endpoint of the pivotal trial only for two drugs. The control groups in RCTs were classified as follows: placebo groups different dosage groups, and active controls groups. Sample sizes have been determined on the basis of feasibility for some ultra-orphan drugs. We provide "Draft Guidance on the Clinical Development of Ultra-Orphan Drugs" based on this research. Conclusions: The development of ultra-orphan drugs requires various arrangements regarding evidence collection, data sources and the clinical trial design. We expect that this draft guidance is useful for ultra-orphan drugs developments in future.
  • 沢登健治, 佐久嶋研, 荒戸照世, 七戸秀夫, 七戸秀夫, 佐藤典宏, 寳金清博, 寳金清博
    レギュラトリーサイエンス学会誌 (一社)レギュラトリーサイエンス学会 7 (2) 91‐97(J‐STAGE) - 97 2185-7113 2017/05 [Not refereed][Not invited]
     
    北海道大学大学院医学研究科は、厚生労働省のシーズ開発・ガイドライン作成・人材交流を目的とした研究事業に採択され、事業実施機関のうちのひとつとして脳梗塞の再生医療に関するプロジェクトを行っている。本プロジェクトによりアカデミアに蓄積される知識や経験を、個々の人材や組織に蓄積されるに留めてしまうのではなく、広く多くのアカデミアが入手・活用できる形とすることが重要である。そのため、規制当局とアカデミアの両方の視点からプロジェクトを振り返り、アカデミアにおける開発の要点をまとめた。振り返りの方法として、これまでのプロジェクトの進め方および定例会議の内容を整理したうえでグループディスカッションを行った。抽出された主な要点として、プロジェクトの進行を遅らせた要因では薬事リテラシーの不足と開発チームの役割分担、よかった点ではプログラムオフィサーによるレビューと規制当局との対面助言が挙げられた。改善策として専門性に基づく役割分担が考えられ、今後の提言として治験が実施されている医療現場の情報の活用が示された。今後、アカデミアが適切かつ迅速に開発を進めるために、今回議論された点を考慮して開発を進めることが重要と考える。(著者抄録)
  • 健康・機能性食品の各国状況比較と国内関連製品の海外展開戦略に関する調査研究
    Yang Siwen, 岡崎 敬, 荒戸 照世, 池田 秀子, 仙石 慎太郎, 児玉 耕太
    日本薬学会年会要旨集 (公社)日本薬学会 137年会 (3) 211 - 211 0918-9823 2017/03 [Refereed][Not invited]
  • 西川秋佳, 平林容子, 真木一茂, 笛木修, 松本峰男, 渡部一人, 木下潔, 鈴木睦, 中澤隆弘, 小比賀聡, 荒戸照世, 藤坂朱紀, 平林容子, 真木一茂, 笛木修, 松本峰男, 渡部一人, 木下潔, 鈴木睦, 中澤隆弘, 小比賀聡, 荒戸照世, 藤坂朱紀, 藤坂朱紀
    医薬品医療機器レギュラトリーサイエンス 47 (10) 724‐729  1884-6076 2016/10/10 [Not refereed][Not invited]
  • 平林容子, 真木一茂, 笛木修, 松本峰男, 渡部一人, 木下潔, 鈴木睦, 中澤隆弘, 小比賀聡, 荒戸照世, 藤坂朱紀, 藤坂朱紀
    医薬品医療機器レギュラトリーサイエンス 47 (8) 568‐574  1884-6076 2016/08/10 [Not refereed][Not invited]
  • 荒戸照世
    医薬品医療機器レギュラトリーサイエンス 47 (7) 510‐516  1884-6076 2016/07/10 [Not refereed][Not invited]
  • Teruyo Arato
    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY 82 (1) 30 - 40 0306-5251 2016/07 [Refereed][Not invited]
     
    Seven biosimilar products have been approved in Japan since the March 2009 publication of the 'Guideline for quality, safety and efficacy assurance of biosimilar products' by the Ministry of Health, Labor and Welfare (MHLW). Four years previously, the 'Guideline on similar biological medicinal products' was issued in the European Union (EU), and 13 products as of February 2016 have been approved as biosimilar. The US Food and Drug Administration (FDA) approved the first biosimilar product in the US in March 2015 and final Guidance was issued at the end of April 2015. Over the past decade, the challenges regarding the development of biosimilar products have been discussed extensively. In this article, the data packages of biosimilar products in Japan are compared with those overseas in order to clarify the concepts used by the Japanese regulatory authority, i.e., the Pharmaceuticals and Medical Devices Agency (PMDA). The challenges in the development of biosimilar products in Japan are also addressed.
  • 西川秋佳, 平林容子, 真木一茂, 笛木修, 松本峰男, 渡部一人, 木下潔, 中澤隆弘, 小比賀聡, 荒戸照世, 藤阪朱紀, 藤阪朱紀
    医薬品医療機器レギュラトリーサイエンス 47 (4) 250‐253  1884-6076 2016/04/10 [Not refereed][Not invited]
  • 平林容子, 真木一茂, 笛木修, 松本峰男, 渡部一人, 木下潔, 中澤隆弘, 小比賀聡, 荒戸照世, 藤坂朱紀, 藤坂朱紀
    医薬品医療機器レギュラトリーサイエンス 47 (2) 101‐104  1884-6076 2016/02/10 [Not refereed][Not invited]
  • 平林容子, 真木一茂, 笛木修, 松本峰男, 渡部一人, 木下潔, 中澤隆弘, 小比賀聡, 荒戸照世, 藤坂朱紀, 藤坂朱紀, 小野寺博志, 篠田和俊
    医薬品医療機器レギュラトリーサイエンス 46 (12) 846 - 851 1884-6076 2015/12/10 [Not refereed][Not invited]
  • Teruyo Arato, Yoshiyuki Yamaguchi, Takashi Daimon, Yuji Heike, Ken Ishii, Kouji Kobiyama, Kyogo Itho, Shinichi Kageyama, Hiroshi Shiku, Yoshihiro Miyahara, Hiroaki Ikeda, Naozumi Harada, Daisuke Muraoka, Yutaka Kawakami, Eiichi Nakayama, Keiya Ozawa, Noriyuki Sato, Masahiro Takeuchi, Kenzaburo Tani, Koji Tamada, Ryuzo Ueda, Takeharu Yamanaka, Hiroki Yamaue, Masaki Yasukawa, Toyotaka Iguchi, Takeshi Terashima, Kohei Amakasu, Shigehisa Kitano, Yasuhiro Nagata, Masanori Noguchi, Takeo Asano, Motohiro Asonuma, Kazuhiro Kakimi, Kazutoh Takesako, Masanori Tanaka, Akira Yamada, Taiki Aoshi, Etsushi Kuroda, Naoya Yamazaki, Aya Kuchiba, Shiro Tanaka, Hirofumi Michimae, Tomomi Yamada, Kenichi Hanada, Hideho Okada, Naoko Takebe, Naoto Hirano, Satoshi Okumura, Masayoshi Shibatsuji, Daisaku Sato, Teruhide Yamaguchi
    Cancer Science 106 (12) 1761 - 1771 1347-9032 2015/12/01 [Refereed][Not invited]
     
    © 2015 Japanese Cancer Association. The development of cancer immunotherapies is progressing rapidly with a variety of technological approaches. They consist of "cancer vaccines", which are based on the idea of vaccination, "effector cell therapy", classified as passive immunotherapy, and "inhibition of immunosuppression", which intends to break immunological tolerance to autoantigens or immunosuppressive environments characterizing antitumor immune responses. Recent reports showing clinical evidence of efficacy of immune checkpoint inhibitors and adoptive immunotherapies with tumor-infiltrating lymphocytes and tumor-specific receptor gene-modified T cells indicate the beginning of a new era for cancer immunotherapy. This guidance summarizes ideas that will be helpful to those who plan to develop cancer immunotherapy. The aims of this guidance are to discuss and offer important points in early phase clinical studies of innovative cancer immunotherapy, with future progress in this field, and to contribute to the effective development of cancer immunotherapy aligned with the scope of regulatory science. This guidance covers cancer vaccines, effector cell therapy, and inhibition of immunosuppression, including immune checkpoint inhibitors.
  • 児玉耕太, 荒戸照世
    日本薬理学雑誌 (公社)日本薬理学会 146 (5) 268 - 274 0015-5691 2015/11 [Not refereed][Not invited]
     
    我が国のライフサイエンス分野の基礎研究成果は国際的にも高い評価を受けているが、実用化に結び付いているとは言えない状況にある。そこで、企業のみならずアカデミアにおける基礎研究シーズの発掘・育成や臨床POC(Proof of Concept)の取得に期待が高まり、医療イノベーションを推進するための種々の施策が講じられてきた。こうした流れを受けて、北海道大学でも創薬に向けてマネジメント体制が構築され、製造販売承認を取得した製品が出始めるとともに、産学連携等も含めた創薬関連大型プロジェクト・研究センターの動きが活発になっている。また、次世代の創薬を担う人材育成のための教育プログラムも充実してきている。本稿では、北海道大学におけるこうした取り組みについて紹介する。(著者抄録)
  • 荒戸照世
    月刊PHARM STAGE 15 (7) 30 - 36 1346-3918 2015/10/15 [Not refereed][Not invited]
  • 西川秋佳, 平林容子, 真木一茂, 笛木修, 松本峰男, 渡部一人, 木下潔, 中澤隆弘, 小比賀聡, 荒戸照世, 小野寺博志, 篠田和俊
    医薬品医療機器レギュラトリーサイエンス 46 (10) 681 - 686 1884-6076 2015/10/10 [Not refereed][Not invited]
  • 平林容子, 真木一茂, 笛木修, 松本峰男, 渡部一人, 木下潔, 中澤隆弘, 小比賀聡, 荒戸照世
    医薬品医療機器レギュラトリーサイエンス 日本公定書協会 46 (8) 523 - 527 1884-6076 2015/08/10 [Not refereed][Not invited]
  • 荒戸照世
    臨床医薬 31 (6) 573 - 587 0910-8211 2015/06/30 [Not refereed][Not invited]
  • 荒戸照世
    くすりと糖尿病 4 (1) 40‐44  2187-6967 2015/06/20 [Not refereed][Not invited]
  • 荒戸照世, 金子真之, 前田浩次郎
    患者数が特に少ない希少疾病に対する医薬品の有効性・安全性評価のためのガイダンス作成に関する研究 平成25-26年度 総合研究報告書 平成26年度 総括・分担研究報告書 21-35,37-39,41-54  2015 [Not refereed][Not invited]
  • 山前浩一郎, 宮本大伸, 今岡丈士, 荒戸照世
    Prog Med 34 (10) 1793 - 1803 0287-3648 2014/10/10 [Not refereed][Not invited]
  • 荒戸照世, 佐藤典宏
    バイオサイエンスとインダストリー バイオインダストリー協会 72 (4) 334 - 338 0914-8981 2014/07/01 [Not refereed][Not invited]
  • 荒戸照世
    ジェネリック研究 8 (1) 25 - 30 1881-9117 2014/06/10 [Not refereed][Not invited]
  • 荒戸照世
    医薬ジャーナル 50 (5) 1396 - 1402 0287-4741 2014/05/01 [Not refereed][Not invited]
  • 荒戸照世
    臨床医薬 30 (2) 93 - 106 0910-8211 2014/02/28 [Not refereed][Not invited]
  • 荒戸照世, 金子真之
    患者数が特に少ない希少疾病に対する医薬品の有効性・安全性評価のためのガイダンス作成に関する研究 平成25年度 総括・分担研究報告書 11 - 28 2014 [Not refereed][Not invited]
  • 荒戸照世
    月刊PHARM STAGE 13 (9) 1 - 7 1346-3918 2013/12/15 [Not refereed][Not invited]
  • 荒戸照世
    Pharm Tech Jpn 29 (13) 2637 - 2642 0910-4739 2013/11/01 [Not refereed][Not invited]
  • 荒戸照世
    レギュラトリーサイエンス学会誌 2 (1) 31 - 40 2185-7113 2012/01/31 [Not refereed][Not invited]
  • Teruhide Yamaguchi, Teruyo Arato
    BIOLOGICALS 39 (5) 328 - 332 1045-1056 2011/09 [Refereed][Not invited]
     
    Recently, WHO, EU, Japan and Canada have published guidelines on biosimilar/follow-on biologics. While there seems to be no significant difference in the general concept in these guidelines, the data to be submitted for product approval are partially different. Differences have been noted in the requirements for comparability studies on stability, prerequisites for reference product, or for the need of comparability exercise for determination of process-related impurities. In Japan, there have been many discussions about the amount and extent of data for approval of follow-on biologics. We try to clarify the scientific background and rational for regulatory pathway of biosimilar/follow-on biologics in Japan in comparison with the guidelines available from WHO. EU and Canada. In this article, we address and discuss the scientific background underlying these differences to facilitate the harmonization of follow-on biologic principles in the guidelines in future. (C) World Health Organization 2011. All rights reserved. The World Health Organization has granted the Publisher permission for the reproduction of this article.
  • Teruyo Arato, Teruhide Yamaguchi
    BIOLOGICALS 39 (5) 289 - 292 1045-1056 2011/09 [Refereed][Not invited]
     
    To share the experience of reviewing clinical data required for the licensing of follow-on biologic products (biosimilar products and similar biotherapeutical products as EU and WHO terminology, respectively) in Japan, the data packages of two follow-on biologics, "Somatropin BS s.c. [Sandoz] (Omnitrope)" and "Epoetin alfa BS UCRI", which have been recently approved in Japan according to the "Guidelines for the Quality, Safety and Efficacy Assurance of Follow-on Biologics" published on March 4th 2009, are described. The clinical data package and indication of Somatropin BS/Omnitrope (R) were different in each country. In case of Epoetin alfa BS KR], non-clinical and clinical data-package was different from those of erythropoietin biosimilar products approved in EU. Submission of post-marketing surveillance plans for both products was required. Even though there seem to be differences in data requirements by each national regulatory authority, the accumulation of experience will provide the rationale and consensus on how to design the clinical trials for follow-on biologics. (C) World Health Organization 2011. All rights reserved. The World Health Organization has granted the Publisher permission for the reproduction of this article.
  • 猪川和朗, 荒戸照世, 東雄一郎, 東雄一郎, 池田佳代, 森川則文
    医薬品医療機器レギュラトリーサイエンス 医薬品医療機器レギュラトリーサイエンス財団 42 (7) 633-638 - 638 1884-6076 2011/07/10 [Not refereed][Not invited]
  • Akira Harazono, Tetsu Kobayashi, Nana Kawasaki, Satsuki Itoh, Minoru Tada, Noritaka Hashii, Akiko Ishii, Teruyo Arato, Shigehiro Yanagihara, Yuki Yagi, Akiko Koga, Yuriko Tsuda, Mikiko Kimura, Masashi Sakita, Satoshi Kitamura, Hideto Yamaguchi, Hisashi Mimura, Yoshimi Murata, Yasuki Hamazume, Takayuki Sato, Shunji Natsuka, Kazuaki Kakehi, Mitsuhiro Kinoshita, Sakie Watanabe, Teruhide Yamaguchi
    BIOLOGICALS 39 (3) 171 - 180 1045-1056 2011/05 [Refereed][Not invited]
     
    The various monosaccharide composition analysis methods were evaluated as monosaccharide test for glycoprotein-based pharmaceuticals. Neutral and amino sugars were released by hydrolysis with 4-7 N trifluoroacetic acid. The monosaccharides were N-acetylated if necessary, and analyzed by high-performance liquid chromatography (HPLC) with fluorometric or UV detection after derivatization with 2-aminopyridine, ethyl 4-aminobenzoate, 2-aminobenzoic acid or 1-phenyl-3-methyl-5-pyrazolone, or high pH anion exchange chromatography with pulsed amperometric detection (HPAEC-PAD). Sialic acids were released by mild acid hydrolysis or sialidase digestion, and analyzed by HPLC with fluorometric detection after derivatization with 1,2-diamino-4,5-methylenedioxybenzene, or HPAECPAD. These methods were verified for resolution, linearity, repeatability, and accuracy using a monosaccharide standard solution, a mixture of epoetin alfa and beta, and alteplase as models. It was confirmed that those methods were useful for ensuring the consistency of glycosylation. It is considered essential that the analytical conditions including desalting, selection of internal standards, release of monosaccharides, and gradient time course should be determined carefully to eliminate interference of sample matrix. Various HPLC-based monosaccharide analysis methods were evaluated as a carbohydrate test for glycoprotein pharmaceuticals by an inter-laboratory study. (C) 2011 The International Alliance for Biologicals. Published by Elsevier Ltd. All rights reserved.
  • 荒戸 照世
    ファームステージ 技術情報協会 11 (1) 5 - 12 1346-3918 2011/04 [Not refereed][Not invited]
  • 荒戸照世, 安藤剛
    Pharm Tech Jpn 26 (6) 915-923 - 923 0910-4739 2010/05/01 [Not refereed][Not invited]
  • 荒戸照世
    医薬品医療機器レギュラトリーサイエンス 41 (1) 47 - 56 1884-6076 2010/01/10 [Not refereed][Not invited]
  • 山口照英, 川西徹, 川崎ナナ, 内田恵理子, 石井明子, 新見伸吾, 荒戸照世, 井口豊崇様, 安藤剛, 横谷進, 安藤潔
    医薬品を巡る環境の変化に対応した日本薬局方の改正のための研究 平成19-21年度 総合研究報告書 47 - 67 2010 [Not refereed][Not invited]
  • 山口照英, 横手公幸, 石原大二郎, 古賀淳一, 大島武博, 久保寺美典, 田中俊充, 高橋智裕, 二名俊彦, 山岸裕司, 中澤秀夫, 斉藤洋之, 神谷潔, 三上忠, 高橋栄二, 岡本智之, 井口富夫, 荒戸照世, 安藤剛, 福永悟史, 榎田綾子, 高山昌也, 鹿野真弓, 奥田晴宏, 川崎ナナ, 新見伸吾, 石井明子, 村岡ひとみ, 遊佐敬介
    医薬品の製造開発から市販後に及ぶ品質確保と改善に関する研究 平成21年度 総括・分担研究報告書 36 - 54 2010 [Not refereed][Not invited]
  • 山口照英, 川西徹, 川崎ナナ, 内田恵理子, 石井明子, 新見伸吾, 荒戸照世, 井口豊崇, 安藤剛, 横谷進, 安藤潔
    医薬品を巡る環境の変化に対応した日本薬局方の改正のための研究 平成21年度 総括・分担研究報告書 61 - 82 2010 [Not refereed][Not invited]
  • 荒戸 照世
    日中医学 日中医学協会 24 (4) 13 - 21 0912-6287 2009/11/25 [Not refereed][Not invited]
  • 荒戸 照世
    ファームステージ 技術情報協会 9 (3) 1 - 3 1346-3918 2009/06 [Not refereed][Not invited]
  • 山口照英, 安藤潔, 横谷進, 荒戸照世, 井口豊崇, 川西徹, 川崎ナナ, 石井明子, 新見伸吾, 内田恵理子
    医薬品を巡る環境の変化に対応した日本薬局方の改正のための研究 平成20年度 総括・分担研究報告書 89 - 109 2009 [Not refereed][Not invited]
  • 山口照英, 川崎ナナ, 荒戸照世, 柳原繁弘, 古賀明子, 中島和幸, 山口秀人, 三村尚志, 濱詰康樹, 窪田雅之, 長束俊治, 掛樋一晃, 内田恵理子, 柚木幹弘, 小紫嘉一, 成瀬毅志
    政策創薬総合研究研究報告書 平成20年度 112 - 121 2009 [Not refereed][Not invited]
  • 山口照英, 川崎ナナ, 荒戸照世, 石川リカ, 古賀明子, 中島和幸, 山口秀人, 濱詰康樹, 窪田雅之, 長束俊治, 掛樋一晃, 内田恵理子, 小紫嘉一, 菅原敬信, 柚木幹弘, 原園景, 伊藤さつき, 小林哲, 高井俊紀, 岡本寿美子, 佐藤貴之, 木下充弘, 島圭介, 山田真希, 柴田伸一, 藤智子, 村上利夫
    政策創薬総合研究研究報告書 平成19年度 112 - 121 2008 [Not refereed][Not invited]
  • 荒戸照世
    遺伝子医学MOOK (8) 213 - 223 1349-2527 2007/07/05 [Not refereed][Not invited]
  • 奥田晴宏, 大森崇, 荒戸照世, 志村紀子, 笛木修
    国際的動向を踏まえた医薬品等の新たな有効性および安全性の評価に関する研究 平成15年度総括研究報告書 平成13-15年度総合研究報告書 75 - 81 2004 [Not refereed][Not invited]
  • 小林 史明, 槇本 博雄, 永井 尚美, 日高 慎二, 荒戸 照世, 柴田 大朗, 奥田 晴宏
    臨床薬理 The Japanese Society of Clinical Pharmacology and Therapeutics 34 (1) 95S - 96S 0388-1601 2003/01/31
  • 奥田晴宏, 大森崇, 荒戸照世, 井出勝久, 志村紀子
    国際的動向を踏まえた医薬品等の新たな有効性および安全性の評価に関する研究 平成14年度総括研究報告書 66 - 71 2003 [Not refereed][Not invited]
  • 豊島聡, 井出勝久, 荒戸照世, 大森崇, 志村紀子
    国際的動向を踏まえた医薬品等の新たな有効性および安全性の評価に関する研究 平成13年度総括研究報告書 91 - 97 2002 [Not refereed][Not invited]
  • Hiraoka Atsushi, Kobayashi Haruo, Arato Teruyo
    Japanese journal of biofeedback research 日本バイオフィードバック学会 26 (0) 28 - 37 0386-1856 1999/03/31 [Not refereed][Not invited]
     
    Factors influencing the human biochemical responses to mental stresses were studied by examining urine samples from male and female subjects before and after receiving two different kinds of mental stresses : per-forming mathematical calculation and riding roller coasters. Psychological tests (MPI and TGE) were also given to all the subjects in order to elucidate the relationship between the psychological characteristics and the biochemical data. The results suggest that the human biochemical responses to mental stresses, which are reflected by changes in the urinary excretion levels of cat...
  • 荒戸 照世, 脇坂 晟, 佐和 弘基
    杏林医学会雑誌 杏林医学会 30 (1) 149 - 149 1999
  • A Hiraoka, T Arato, Tominaga, I, N Eguchi, H Oda, Y Urade
    JOURNAL OF CHROMATOGRAPHY A 802 (1) 143 - 148 0021-9673 1998/04 [Refereed][Not invited]
     
    Molecular mass (M-r) microheterogeneity of beta-trace protein (beta TP) in cerebrospinal fluid (CSF) from patients with various neurological disorders was analyzed by sodium dodecyl sulfate capillary gel electrophoresis. Under the conditions employed, beta TP with a M-r distribution of 23 000-30 000 was roughly separated into two subfractions containing the major peaks with M-r of 26 000 and 28 500, respectively. The peak area ratios of the two subfractions on the electropherograms varied among the samples examined, and elevation in the total beta TP level in the CSF from patients with organic diseases in the central nervous system (CNS) was often accompanied by changes in the ratios of the subfractions. The quantitative changes in the subfraction level in CSF beta TP are considered to reflect the pathological alterations in the CNS. (C) 1998 Elsevier Science B.V.
  • A Hiraoka, T Arato, Tominaga, I, N Eguchi, H Oda, Y Urade
    JOURNAL OF CHROMATOGRAPHY B 697 (1-2) 141 - 147 0378-4347 1997/09 [Not refereed][Not invited]
     
    Proteins of low molecular mass (M-r) in human cerebrospinal fluid (CSF) were analyzed by capillary electrophoresis in a sodium dodecyl sulfate-containing polymer solution. Under the conditions employed, peaks of beta(2)-microglobulin (beta MG) (M-r: 11 700), gamma-trace protein (12 300), myelin basic protein (18 000), beta-trace protein (beta TP) (23 000 to 30 000) and alpha(1)-acid glycoprotein (42 000) were detected on the electropherograms. The concentrations of beta MG and beta TP were determined based on the peak area relative to that of an internal standard, Orange G, which was added at a constant amount as the front marker. It was demonstrated that their levels in CSF change under various pathological conditions in the central nervous system. (C) 1997 Elsevier Science B.V.
  • A Hiraoka, T Arato, Tominaga, I, A Anjyo
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 15 (9-10) 1257 - 1263 0731-7085 1997/06 [Refereed][Not invited]
     
    Ordinary capillary-zone electrophoresis (CZE), as well as CZE in a sodium dodecylsulfate-containing polymer solution (SDS-CZE) and capillary isoelectrofocusing (CIEF), was applied to the analysis of low molecular weight proteins in cerebrospinal fluid (CSF) from patients with various neuropsychiatric disorders. Under the CZE conditions employed, a peaks of beta-trace protein (beta PTP), which is the most abundant low MW protein in CSF, was clearly detected on the electropherograms of all the samples examined, and the CSF beta TP level could be tentatively determined using allylamine added at a constant concentration as the internal standard. The results revealed that beta TP in CSF was non-specifically increased in organic diseases in the central nervous system (CNS), especially in ones giving severe physical damage to the brain tissues. On the other hand, SDS-CZE allowed us to determine simultaneously the CSF minor low MW proteins other than beta TP, such as beta(2)-microglobulin, gamma-trace protein, myelin basic protein, etc., while the CIEF electropherograms suggested that beta TP were separated into several fractions with the different PI values. These capillary electrophoresis systems seem to be powerful as aids in the biochemical examinations of beta TP and other low molecular weight proteins in CSF from patients with CNS diseases. (C) 1997 Elsevier Science B.V.
  • 平岡 厚, 荒戸 照世, 富永 格, 前田 昌徹
    JOURNAL OF THE KYORIN MEDICAL SOCIETY 杏林医学会 28 (4) 570 - 571 0368-5829 1997
  • A Hiraoka, T Arato, Tominaga, I
    BIOLOGICAL & PHARMACEUTICAL BULLETIN 20 (1) 91 - 93 0918-6158 1997/01 [Not refereed][Not invited]
     
    Reduction in the blood free carnitine (FC) level as a side effect of sodium valproate (VPA) given epileptic patients was pharmacokinetically studied in connection with changes in the VPA disposition, The serum FC level in patients taking at least one of phenobarbital (PB), phenytoin (PHT) and/or carbamazepine (CBZ) in addition to VPA was significantly lower than that in the controls given only these other anti-epileptic drugs (AEDs), Patients medicated only with VPA also tended to have a lower serum FC level than the controls, although the difference was not significant, Among all the patients taking VPA with or without other AED(s), a significantly positive correlation was observed between the serum FC level and the value of dose and level ratio (L/D) of VPA, indicating that both the serum PC concentration and the L/D value of VPA were remarkably reduced in those patients receiving both medications, These results suggested that reduction in the blood FC level as a side effect of VPA reflected FC deficiency associated with the accelerated degradation of VPA in liver; such a condition appears to result from medication with VPA and other AED(s) which induce(s) enzyme(s) for the VPA metabolism.
  • HIRAOKA Atsushi, ARATO Teruyo, TOMINAGA Itaru
    Japanese journal of electrophoresis 日本電気泳動学会 40 (4) 193 - 197 0031-9082 1996/08/15 [Not refereed][Not invited]
     
    Capillary zone electrophoresis (CZE) was applied to the separation and determination of two major monoamine metabolites, 5-hydroxyindoleacetic acid (5-HIAA) and homovanillic acid (HVA) in cerebrospinal fluid (CSF) from patients with neuropsychiatric disorders. Ethyl acetate extracts of acidified CSF were analyzed by CZE with ultraviolet absorbance detection (UVD). The peaks of 5-HIAA and HVA were clearly detected on the electropherograms, and their levels in the CSF samples were determined on the basis of the peak-area ratios relative to p-methoxybenzoate spiked as an internal standard. The results showed that the CSF levels of 5-HIAA and HVA reduced in patients with some diseases, such as Parkinson's disease, Altzheimer's disease, depressive illness, etc., supporting the conclusions obtained earlier by high-performance liquid chromatography (HPLC). The present CZE-UVD system, which consumes only a far smaller amout of sample solutions to be injected than that required in HPLC-UVD, seems to be useful as an aid in the biochemical diagnosis of neuropsychiatric disorders, especially in distinguishing dementia associated with central nervous system-degenerative diseases (both of the 5-HIAA and HVA levels in CSF are reduced) from that with cerebrovascular diseases (neither the CSF 5-HIAA nor HVA levels are changed).
  • Hiraoka Atsushi, Kobayashi Haruo, Arato Teruyo, Ohsuga Mieko
    Current biofeedback research in Japan 日本バイオフィードバック学会 1995 (0) 29 - 34 0918-3272 1996 [Not refereed][Not invited]
     
    The biochemical responses to mental stress in male and female subjects were investigated by examining changes in the relative concentrations to creatinine of catecholamines and some minerals in urine taken before and after stressful psychological tests. The excretions into urine of these substances were generally increased by receiving the stress, but changes in the catecholamine and zinc excretions in females were later than those in males. The results of psychological tests including ones used as stressors suggested that subjects in the unhealthy mental state exhibited the greater biochem...
  • HIRAOKA Atsushi, AKAI Junichiro, MIURA Isao, ARATO Teruyo, SATO Mitsuhiko, MAEDA Masaakira
    Biomedical research on trace elements 6 (1) 29 - 36 0916-717X 1995/03/31 [Not refereed][Not invited]
  • A HIRAOKA, J AKAI, TOMINAGA, I, M HATTORI, H SASAKI, T ARATO
    JOURNAL OF CHROMATOGRAPHY A 680 (1) 243 - 246 0021-9673 1994/09 [Refereed][Not invited]
     
    Organic acids in cerebrospinal fluid (CSF) from patients with various central nervous system (CNS) diseases were determined by capillary zone electrophoresis (CZE). Under one of the two sets of conditions employed, several anionic components of CSF were separated into corresponding peaks on the electropherograms and determined. The other conditions employed were also useful in measurement of the lactate contents in CSF. The CSF levels of lactate and pyruvate and the ratios of lactate to pyruvate were elevated in patients with cerebral infarction and bacterial meningitis, whereas CSF ascorbate was reduced mainly in inflammatory disorders of the CNS. The results showed that CZE can become a powerful tool in the biochemical diagnosis of CNS diseases.
  • 荒戸 照世, 脇坂 晟
    杏林医学会雑誌 杏林医学会 25 (1) 163 - 163 1994
  • 古橋 由美, 高橋 伸子, 藤原 隆明, 荒戸 照世, 脇坂 晟
    杏林医学会雑誌 杏林医学会 25 (1) 162 - 162 1994
  • 古橋由美, 藤原隆明, 荒戸照世, 脇坂あきら
    医学のあゆみ 167 (12/13) 907 - 908 0039-2359 1993/12/25 [Not refereed][Not invited]
  • 古橋由美, 藤原隆明, 荒戸照世, 脇坂あきら
    あたらしい眼科 10 (5) 847 - 849 0910-1810 1993/05 [Not refereed][Not invited]
  • 古橋 由美, 高橋 伸子, 藤原 隆明, 荒戸 照世, 脇坂 晟
    杏林医学会雑誌 杏林医学会 24 (1) 160 - 160 1993
  • 荒戸 照世, 脇坂 晟
    杏林医学会雑誌 杏林医学会 24 (1) 131 - 131 1993
  • 荒戸 照世, 古橋 由美, 永松 信哉, 脇坂 晟
    杏林医学会雑誌 杏林医学会 23 (1) 103 - 103 1992

MISC

Books etc

  • 国立医薬品食品衛生研究所, 山口 照英, 協和発酵キリン, 野村 英昭, クレディ・スイス証券, 酒井 文義, 早川, 元FDA審査官, 川上 浩司, 独, 医薬品医療機器総合機構, 荒戸 照世, 日本ケミカルリサーチ, 毛利 善一, PwC PRTM, 仲村, 旭硝子, 株, 吉武 彰文, 株, 応用医学研究所, 瓜生, 匡英, 技術情報協会 
    技術情報協会 2011 (ISBN: 4861043891) 291

Presentations

Research Projects

  • Japan Society for the Promotion of Science：Grants-in-Aid for Scientific Research
    Date (from‐to) : 2015/04 -2019/03 
    Author : KODAMA KOTA, Mohamed Farid
     
    Since its inception in Japan, functional food has continued to deliver a true added value to a wide spectrum of customers, especially in aging subpopulations. Japanese companies have strong "R&D" capabilities and strong know-how in the field of functional foods. They have the opportunity to grow overseas by promoting and marketing their products. The main challenge is to understand the foreign markets and their regulations to be able to promote Japanese products overseas. To achieve this goal, the study reports a scientific review of the relevant literature and official legislative reports published by the authorized entities in several countries to create a comparison between the rules and regulations in different countries. The study results provide suggestions for entry strategies to recommended foreign markets based on regulatory situations. The study also provides a comparison for the different functional food regulations in Japan (FOSHU, FNFC, FFC).
  • 日本学術振興会：科学研究費助成事業
    Date (from‐to) : 1997 -1998 
    Author : 荒戸 照世
     
    角膜の上皮欠損は周囲の上皮細胞の欠損部位への伸展・移動と,その後におこる細胞増殖によって再生・修復されることが知られている.上皮欠損部への細胞移動の時期には上皮基底部よりもむしろ角膜輪部において分裂増殖が盛んであるが,上皮欠損部が被覆されると基底細胞の分裂増殖が開始され上皮は厚さ回復していくと考えられている.しかしながら,こうした細胞の分裂増殖のスイッチを直接つかさどっているものが何であるかは解明されていない.そこでラット角膜創傷モデルをもちい,細胞周期制御とくにG1期制御をつかさどるサイクリンD1やこれに遅れてG1後期に発現するサイクリンEの創傷治癒の各段階における発現の差異を免疫組織化学染色により検討した.上皮細胞の伸展・移動の時期には角膜輪部においてサイクリンEならびにサイクリンD1の発現が見られたのみならず,欠損部周辺の上皮基底細胞においてもこれらの発現が観察された.さらに上皮欠損部が被覆されると上皮基底細胞においてサイクリンEの発現が増大していた.増殖能についても抗PCNA抗体を用いた免疫組織化学染色で調べてみると,サイクリンの発現と増殖能が相関していることが明らかになった.これらの結果から,角膜創傷治癒時においてもサイクリンが増殖をつかさどる一因であること,また,上皮欠損部が完全に被覆される以前に上皮基底細胞においてもサイクリンの発現増大が見られる等の新しい知見が得られた.

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