No Observed Adverse Effect Levelとは 意味・読み方・使い方

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

Case1 is the case approaching the Minimal Anticipated Biological Effect Level (MABEL) and Case2 differs from the conventional use of the No Observed Adverse Effect Level (NOAEL). When calculating the first-in-human dose, the majority of cases will fall into the following categories: cases in which the dose per unit body weight will be obtained from the MABEL or NOAEL (mg/kg) and will then be divided by a safety factor; cases in which the dose (mg/m2) per unit body surface area (m2) will be used for conversion to the Human Equivalent Dose (HED) to ensure equivalence between study animals and human subjects.例文帳に追加

事例１は NOAELを設定根拠した事例，事例２は MABEL を設定根拠にした事例を示しますが，これらの事例のように体重あたりの投与量として得られた MABELまたは NOAEL（mg/kg）の他 - 厚生労働省