論文掲載のお知らせ(IWGT推奨事項)

論文掲載のお知らせ(IWGT推奨事項)

2020年1月9日
シミックファーマサイエンス株式会社

シミックファーマサイエンス株式会社では、2017年11月より International Workshop on Genotoxicity Testing (IWGT)における産学官の国際的遺伝毒性専門家による科学的議論と合意形成に参画し、最新データに基づいた標準的手法、評価アプローチなどのIWGT推奨事項を纏めておりました。
このIWGT推奨事項はレギュラトリーサイエンスに大きな影響を与え、OECD、ICH-S2(R)などのガイドライン改訂、作成時に反映されるものです。

今回、当社の社員が担当した復帰変異原性試験のWorking Subgroup: Revisit the Salmonella mutagenicity (Ames) testにおける科学的議論と合意事項、纏められたIWGT推奨事項の内容が公開されましたので、お知らせいたします。

著者 Dan D. Levy, Errol Zeiger, Patricia A. Escobar, Atsushi Hakura, Bas-jan M. van der Leede, Masayuki Kato, Martha M. Moore, Kei-ichi Sugiyama
表題 Recommended criteria for the evaluation of bacterial mutagenicity data (Ames test)
雑誌 Mutation Research, Genetic Toxicology and Environmental Mutagenesis, Volume 848, November 2019, 403074.
 
著者 Dan D. Levy, Errol Zeiger, Patricia A. Escobar, Atsushi Hakura, Bas-jan M. van der Leede, Masayuki Kato, Martha M. Moore, Kei-ichi Sugiyama
表題 Demonstrating laboratory proficiency in bacterial mutagenicity assay for regulatory submission
雑誌 Mutation Research, Genetic Toxicology and Environmental Mutagenesis, Volume 848, November 2019, 403075.

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