前臨床試験の英語

増量判定基準は事前に非臨床試験データ，類似医薬品データを基に検討し，治験実施計画書に記載すべきである．例文帳に追加

Criteria for dose increase should be based on non-clinical study data and data from comparable similar drug substances, and should be described in the protocol. - 厚生労働省

通常の尿試験紙法や臨床症状による判定がなされるより前に、早期に糖尿病性腎症を検出し進展度を判定する方法を提供する。例文帳に追加

To provide a method for judging an extension degree of a diabetic nephropathy by early detecting the diabetic nephropathy before judgment of a regular urine testing paper method or a clinical symptom is conducted. - 特許庁

(a) 当該申請の対象である医薬品の研究及び開発に支出された連邦資金の金額及び出所の明細，及び (b) 団体の名称であって， (i) その団体と申請人が契約を有しているもの，及び (ii) 連邦資金を受領したもの，及び (c) 申請の対象である医薬品に関する，臨床前研究及び臨床試験を含む各種の研究及び開発の総支出金額例文帳に追加

(a) details of the amount and origin of any Commonwealth funds spent in the research and development of the drug which was the subject of the application; and (b) the name of anybody: (i) with which the applicant has a contractual agreement; and (ii) which is in receipt of Commonwealth funds; and (c) the total amount spent on each type of research and development, including pre-clinical research and clinical trials, in respect of the drug which was the subject of the application.発音を聞く  - 特許庁

前臨床試験期間は、医薬品の有効成分である化学物質の有用性を研究開発する期間としての性格が濃く、一般の分野でいう製品開発期間に近いものと考えられ、承認を受けることに密接に関係した試験期間とは必ずしもいえないため、特許発明の実施をすることができなかった期間に含まれない。例文帳に追加

The period during which preclinical testing was conducted should be regarded as a research and development period to study the utility of the chemical substance that is the active ingredient of the drug product, which is similar to a product development period in general fields of industry. Such period is not necessarily regarded as a testing period that is closely related to obtaining approval. Because of this, the period during which preclinical testing was conducted might not be included in the period during which the patented invention was unable to be worked.発音を聞く  - 特許庁