NOAELとは 意味・読み方・使い方

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

When the methods of calculation (e.g. NOAEL, MABEL) give different estimates, the first-in-human dose should be determined on the basis of scientific evidence.例文帳に追加

ヒトへの初回投与量を設定する上で，NOAEL，MABEL等の設定根拠の違いにより異なる値が得られた場合は，科学的根拠に基づいて初回投与量を決定する． - 厚生労働省

That is, the initial dose is obtained by dividing NOAEL 10mg/kg by the safety factor 10, so it can be calculated at 1 mg/kg.例文帳に追加

すなわち，NOAEL10 mg/kg を安全係数10で除し，初回投与量を 1 mg/kg と算出した． - 厚生労働省

A Provided specific examples of does setting in first-in-human administration using two model cases of monoclonal antibody drags which have pharmacological action that provided receptor blocking against target molecules (although the NOAEL from toxicological studies was 10 mg/kg in both cases).例文帳に追加

A 2 種類の標的分子の活性中和を薬理作用とするモノクローナル抗体医薬品のモデル事例（両事例とも毒性試験から得られている NOAEL は 10mg/kg の場合）を使って，ヒト初回投与量の設定の具体例を示します。 - 厚生労働省

(Case 1)In this case, clinical dose and Mechanism of Action (MoA) of the investigational products are already clear from currently available similar drag products with the same target molecule. Therefore the initial dose in first-in-human administration is calculated from the NOAEL based on toxicological text using cynomolgous monkey as an animal model.例文帳に追加

（事例１）既に同じ分子を標的とした類似医薬品が市販され，類似医薬品での臨床用量や作用機序等が明確であったため，カニクイザルを動物モデルとした毒性試験から NOAELを基準とした初回投与量を算出した． - 厚生労働省

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