Publications by authors named "Shigeru Hisada"

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ICH S1 prospective evaluation study and weight of evidence assessments: commentary from industry representatives.
John L Vahle, Joe Dybowski, Michael Graziano, Shigeru Hisada, Jose Lebron

Front Toxicol· May 2024

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Survey of tumorigenic sensitivity in 6-month rasH2-Tg mice studies compared with 2-year rodent assays.
Shigeru Hisada, Kenjiro Tsubota, Kenji Inoue, Hisaharu Yamada, Takanori Ikeda

J Toxicol Pathol· January 2022

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General considerations regarding the in vitro and in vivo properties of block copolymer micelle products and their evaluation.
Kumiko Sakai-Kato, Nobuhiro Nishiyama, Masato Kozaki, Takeshi Nakanishi, Yoshihiro Matsuda, Shigeru Hisada

J Control Release· July 2015

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Study for collecting background data on Wistar Hannover [Crl:WI(Han)] rats in embryo-fetal development studies--comparative data to Sprague Dawley rats.
Ken-ichi Noritake, Takashi Ikeda, Keiichi Ito, Yoji Miwa, Mika Senuma, Shigeru Hisada

J Toxicol Sci· September 2014

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Study for collecting background data on Wistar Hannover [Crl:WI(Han)] rats in general toxicity studies--comparative data to Sprague Dawley rats.
Kazuhiro Hayakawa, Yuichi Mimura, Shigehiro Tachibana, Mami Furuya, Terutaka Kodama, Shigeru Hisada

J Toxicol Sci· September 2014

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Spleen-specific development of germinal centers in rats treated with antithyroid drugs.
Motoko Fukui, Norio Fukui, Kuniyoshi Sakai, Yuko Hasegawa, Shuji Nagasaki, Shigeru Hisada

J Toxicol Pathol· December 2013

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Potentials and limitations of nonclinical safety assessment for predicting clinical adverse drug reactions: correlation analysis of 142 approved drugs in Japan.
Chihiro Tamaki, Takashi Nagayama, Masamichi Hashiba, Masato Fujiyoshi, Masanori Hizue, Shigeru Hisada

J Toxicol Sci· October 2013

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Collaborative work on evaluation of ovarian toxicity by repeated-dose and fertility studies in female rats.
Atsushi Sanbuissho, Midori Yoshida, Shigeru Hisada, Fumio Sagami, Satoshi Kudo

J Toxicol Sci· June 2009

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Morphological characterization of the ovary under normal cycling in rats and its viewpoints of ovarian toxicity detection.
Midori Yoshida, Atsushi Sanbuissyo, Shigeru Hisada, Michihito Takahashi, Yasuo Ohno

J Toxicol Sci· June 2009

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Collaborative work on evaluation of ovarian toxicity. 1) Effects of 2- or 4-week repeated-dose administration and fertility studies with medroxyprogesterone acetate in female rats.
Sachiyo Ohtake, Motoko Fukui, Shigeru Hisada

J Toxicol Sci· June 2009

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Safety assessment of biopharmaceuticals: Japanese perspective on ICH S6 guideline maintenance.
Takahiro Nakazawa, Misao Kurokawa, Kazuya Kimura, Akihiro Wakata, Shigeru Hisada

J Toxicol Sci· August 2008

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Development of the ICH guidelines for immunotoxicology evaluation of pharmaceuticals using a survey of industry practices.
James L Weaver, Naohisa Tsutsui, Shigeru Hisada, Jean-Marc Vidal, Steven Spanhaak

J Immunotoxicol· July 2005

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Interlaboratory comparison of short-term carcinogenicity studies using CB6F1-rasH2 transgenic mice.
Masaya Takaoka, Shinya Sehata, Takanori Maejima, Toshio Imai, Mikinori Torii, Shigeru Hisada

Toxicol Pathol· October 2003

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