よむ、つかう、まなぶ。
資料３－３ ストラテラカプセル及びストラテラ内用液にて検出された新規ニトロソアミンの限度値について（企業見解）［7.8MB］ (6 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_42464.html |
| 出典情報 | 薬事審議会 医薬品等安全対策部会安全対策調査会（令和6年度第5回 8／28）《厚生労働省》 |
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Regulatory Response
Page 4
Lilly believes a mechanism-based risk assessment paradigm for calculation of AI is scientifically
justified and warranted in that:
mutation is a relevant and sensitive endpoint for the assessment of carcinogenic risk of
nitrosamines,
the transgenic rodent model is a robust and well-validated model to assess mutagenicity
in vivo.
Further, derivation of the AI using the NOEL or BMDL from the in vivo mutagenicity data is a
conservative estimate of risk because:
the mutagenicity endpoint, as a required precursor to carcinogenicity for nitrosamines, is
more conservative than a tumor endpoint,
use of a dose causing no effects (NOEL) as the point of departure is more conservative
than using a dose eliciting a 50% tumor rate in rodents (eg, the TD50).
LY139603
VV-REG-326326
v1.0
Page 4 of 5
6 / 34 ページ
Eli Lilly Confidential
Page 4
Lilly believes a mechanism-based risk assessment paradigm for calculation of AI is scientifically
justified and warranted in that:
mutation is a relevant and sensitive endpoint for the assessment of carcinogenic risk of
nitrosamines,
the transgenic rodent model is a robust and well-validated model to assess mutagenicity
in vivo.
Further, derivation of the AI using the NOEL or BMDL from the in vivo mutagenicity data is a
conservative estimate of risk because:
the mutagenicity endpoint, as a required precursor to carcinogenicity for nitrosamines, is
more conservative than a tumor endpoint,
use of a dose causing no effects (NOEL) as the point of departure is more conservative
than using a dose eliciting a 50% tumor rate in rodents (eg, the TD50).
LY139603
VV-REG-326326
v1.0
Page 4 of 5
6 / 34 ページ
Eli Lilly Confidential