臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
41 巻, 4 号
選択された号の論文の27件中1~27を表示しています
特集/レギュラトリーサイエンス
  • 小野 俊介, 津谷 喜一郎
    2010 年 41 巻 4 号 p. 125-126
    発行日: 2010年
    公開日: 2010/10/08
    ジャーナル フリー
  • 齋藤 充生, 東 雄一郎, 長谷川 隆一
    2010 年 41 巻 4 号 p. 127-131
    発行日: 2010年
    公開日: 2010/10/08
    ジャーナル フリー
    The National Institute of Health Sciences (NIHS) is the oldest national institute in Japan. The NIHS is engaged in so-called regulatory science, which harmonizes science/technology and daily human life. The Division of Medicinal Safety Sciences (MSS) was founded in 2002, and is one of the newest branches of the NIHS. The aim of the MSS is to conduct basic research concerning post-marketing drug safety. Its main research topics are as follows: research on severe cutaneous adverse events (Stevens-Johnson syndrome/toxic epidermal necrolysis) and related gene markers, analysis of the relationship between response to selective serotonin reuptake inhibitors and gene markers, research on individual factors associated with adverse effects of anticancer drugs, investigation of individual factors that affect P-glycoprotein expression level, drug utilizing study, survey of attitudes toward the necessary information of drug labeling, research on conflict of interest in collaboration study with drug companies, and comparative pharmacokinetic study between the East Asians and Caucasians. As listed above, the MSS covers broad research areas, but its research purpose of post-marketing drug safety study is well defined. The MSS is a unprecedent case of regulatory science research. The unique standpoint of the MSS will be strengthened by interdisciplinary collaboration.
  • 佐瀬 一洋
    2010 年 41 巻 4 号 p. 133-139
    発行日: 2010年
    公開日: 2010/10/08
    ジャーナル フリー
    Medical devices are expected to play more important roles in improving prevention, diagnosis, and treatment of, for example, cardiovascular diseases, the leading causes of death and disabilities in aging population. Percutaneous coronary intervention (PCI) has been one of the fastest growing categories in medical devices to be challenged by clinical trials to test improvement in quality of life or survival of patients with ischemic heart disease. Since clinical evaluations of PCI have evolved into healthy competition among PCI, bypass surgery, and pharmacotherapy, all stakeholders including industry, regulatory authority, as well as medical practitioner equally benefit from constant improvements, and, ultimately, patients are winners. Pharmaceutical Affairs Law of Japan (PAL) has constantly been amended in parallel to global regulatory guidance documents. PAL categorizes diagnostic and therapeutic medical devices into classes according to risks. It integrates frameworks like the Essential Principles so that reviewers and/or conformity assessment bodies can take harmonized approach to facilitate approval processes. Discussions about so-called “Device Lag”, some argues US/EU approved devices should immediately be approved in Japan while others argue innovative Japanese manufactures should find more market outside of Japan, reminds us all that regulatory harmonization should be mutually beneficial. The Global Harmonization Task Force (GHTF) has been conceived in an effort to achieve greater uniformity between national medical device regulatory systems. The Harmonization by Doing (HBD) is a pragmatic effort to conduct US-Japan international clinical investigations and FDA-PMDA/MHLW joint reviews. Activities like GHTF and HBD could complement each other to effectively harmonizing regulatory processes while leaning from experiences.
  • 畝山 智香子
    2010 年 41 巻 4 号 p. 141-145
    発行日: 2010年
    公開日: 2010/10/08
    ジャーナル フリー
    Risk analysis has been developed as a tool for food safety authority to ensure improvement of food safety. Risk analysis is a structured decision-making process with three components: risk management, risk assessment and risk communication. Among these three components, risk assessment can be described as a branch of regulatory science. A brief description of food safety risk analysis and some scientific challenges which should be addressed in Japan are described in this article.
  • 小野寺 博志
    2010 年 41 巻 4 号 p. 147-152
    発行日: 2010年
    公開日: 2010/10/08
    ジャーナル フリー
    Drugs have to be evaluated from a different viewpoint from other toxic substances such as natural toxins, environment substances and chemicals. Toxicological evaluations are also important to clarify the benefits and risks of pharmaceuticals to humans. Many of the toxicology studies are conducted according to guidelines. The type and timing of toxicology studies have been harmonized internationally. Recently, the ICH guidelines have been revised in light of technological advances and reduction of animal usage in accordance with the 3R (reduce/refine/replace) principle. The results of toxicology studies must always be evaluated based on extrapolation to humans. The goal of regulatory science is to predict a risk based on the latest information and evaluate safety. Even if the toxicological findings are similar, the toxicological acceptability assessment is not always the same. It is important that the toxicology for pharmaceutical products is evaluated on a case-by-case basis.
第16回 臨床薬理学講習会(2009年度) 「基礎から学ぶ臨床薬物動態」
第30回 日本臨床薬理学会年会記録
シンポジウム11:マイクロドーズ臨床試験の現状と未来
シンポジウム17:臨床研究の実施体制の構築
シンポジウム19:臨床研究における臨床薬理学の貢献
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