生物学的係数の英語

① ヒト及び適切な動物種由来の標的細胞を用いた受容体／標的への結合親和性及び占有率についての試験 ② ヒト及び適切な動物種由来の標的細胞を用いた用量－反応曲線 ③ 適切な動物種を用いた薬理学的用量における推定曝露量ヒトにおける有害作用の発現を回避するために，安全係数を適用して，MABELから初回投与量を設定する場合には，被験薬の新規性，生物学的活性，作用機序，被験薬の種特異性，用量作用曲線の型等を踏まえ，適切な安全係数を設定すべきである．例文帳に追加

(1) Studies of receptor/target binding affinity and occupancy, using target human cells or cells from appropriate animal species (2) Dose-response curves in target human cells or cells from appropriate animal species (3) Estimated exposure in humans at pharmacological doses in appropriate animal species. In order to avoid the potential for adverse reactions in humans, a safety factor may be applied in the calculation of the first-in-human dose from the MABEL. This should take into account risk factors such as the novelty, bioactivity, and mode of action of the investigational product, the degree of species specificity, the shape of the dose-response curve, and the degree of uncertainty in the calculation of the MABEL. The appropriate safety factors should be set. - 厚生労働省