clinical levelとは 意味・読み方・使い方

This device has a built-in database and a built-in spreadsheet providing a unified platform to all the clinical investigations in the medical fields including work in a laboratory and high-level clinical investigations being the core in clinic without restriction.例文帳に追加

この装置は、限定はしないが、臨床でコアとなる実験室の作業および高度な臨床調査を含む、医学分野のすべての臨床調査に対し、統一されたプラットフォームを提供するビルト・イン・データベースとビルト・イン・スプレッドシートを有する。 - 特許庁

Generally, the first-in-human dose will be selected as follows. First, the No Observed Adverse Effect Level (NOAEL) will be determined for the most highly sensitive animal species used in non-clinical studies. Next, the Human Equivalent Dose (HED) will be calculated based on those values, with the appropriate application of allometric correction or pharmacokinetic (PK) information.Considerations will include a safety factor based on the investigational product properties and the clinical study design.例文帳に追加

一般にヒト初回投与量は，最も感度の高い動物種を用いた非臨床毒性試験における無毒性量（NOAEL:No Observed Adverse Effect Level）をもとに，アロメトリック補正，あるいは，薬物動態(PK)情報に基づいてヒト等価用量（HED:Human Equivalent Dose）を算出し，さらに被験薬の特性や臨床試験デザインを踏まえた安全係数を考慮し設定される． - 厚生労働省

During this period, along with progression of M&A between pharmaceutical companies, international evolution has progressed mainly in large-scale companies and the foreign sales ratio has increased to the level of nearly 50%. The assistance measures by the government such as activation of clinical trials begin to achieve an effect for example, the number of clinical trial notification turns to increase.例文帳に追加

・ この間、製薬企業間のＭ＆Ａが進むとともに、大企業を中心に国際展開が進み、海外売上高比率も 50％に近い水準に上昇してきた。また、治験活性化などの国の支援策も治験届数が増加に転じるなど、徐々に効果を上げ始めている。 - 厚生労働省

During this period, along with progression of M&A between pharmaceutical companies, international evolution has progressed mainly in large-scale companies and the foreign sales ratio has increased to the level of nearly 50%. The assistance measures by the government such as activation of clinical trials begin to achieve an effect for example, the number of clinical trial notification turns to increase.例文帳に追加

この間、製薬企業間のＭ＆Ａが進むとともに、大企業を中心に国際展開が進み、海外売上高比率も 50％に近い水準に上昇してきた。また、治験活性化などの国の支援策も治験届数が増加に転じるなど、徐々に効果を上げ始めている。 - 厚生労働省

To learn a high-level technique, even without having any clinical experience, through training sensuously similar to an actual technique in techniques such as dissection or skin stitching.例文帳に追加

切開や皮膚縫合といった、医療現場における手技について、感覚的に実際の手技に近似した研修を通して、臨床経験によらなくても、高度な手技の習得を可能にすることにある。 - 特許庁

To provide an endoscope operation training apparatus with which an operation technique required for inspection and treatment by the endoscope can be obtained on feeling close to a practical clinical condition at high level.例文帳に追加

内視鏡検査や治療に必要な操作技術を実際の臨床状態に極めて近い感触により高いレベルで習得することができる内視鏡操作トレーニング装置を提供すること。 - 特許庁

The number of subjects per dose (the cohort size) depends on the variability of both pharmacokinetic (PK) and pharmacodynamic (PD) parameters, and also depends on the study objectives and the information required to progress to the next dose level or the next clinical study.例文帳に追加

被験者の数（コホートの大きさ）は薬物動態（PK）並びに薬力学（PD）パラメータの変動の程度及び次の用量・試験へ進むために必要な情報や試験目的によって決まる． - 厚生労働省

In particular, as the streamlining of clinical trials, etc., require detailed reviews, a "Working Group Regarding the Streamlining of Clinical Trials, etc." was established, and reviews centered on the three main items of cost, speed, and quality were conducted. Although steady overall improvements were seen due to efforts made by the relevant parties thus far, it was shown that there are issues that still need to be resolved in order for Japan to receive a certain level of recognition in terms of an environment to implement clinical trials from a global perspective, and uniform evaluation indicators need to be established for these items, etc. (refer to Attachment 2 "Working Group Investigation Results Regarding the Streamlining of Clinical Trials").例文帳に追加

特に、治験の効率化等についてはより詳細な検討を要することから「治験の効率化等 に関するワーキンググループ」を設置し、コスト、スピード、質の主要な3つの事項を中心に検討が行われ、これまでの関係者の取組みにより全体として着実な改善がみられたものの、我が国が治験を実施する環境として世界的な視点から一定の評価を得るためにはまだ解決すべき課題があること、及びそれらの事項について一定の評価指標を定める必要があること等の評価及び課題が示された（添付資料2 「治験の効率化等に関する ワーキンググループ検討結果」参照）。 - 厚生労働省