ICH三極調整・医薬品生殖毒性試験法ガイドラインについて (Topics on Regulatory Toxicology (3))
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| Published in | Journal of toxicological sciences Vol. 21; no. 4; pp. App197 - App204 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | Japanese |
| Published |
一般社団法人 日本毒性学会
1996
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| Online Access | Get full text |
| ISSN | 0388-1350 1880-3989 |
| DOI | 10.2131/jts.21.4_App197 |
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| Author | 黒川, 雄二 田中, 悟 |
|---|---|
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| Copyright | 日本トキシコロジー学会 |
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| References | 4) US-FDA (1966): Guidelines for reproduction studies for safety evaluation of drugs for human use. 9) 田中悟, 他(1996): 医薬品の生殖発生毒性試験法ガイドライン (案), 医薬品規制ハーモナイゼーション推進国際共同研究•平成7年度厚生科学研究業績報告書, 98-117. 7) 厚生省薬務局(1994): 医薬品の生殖毒性検索のための試験法ガイドライン, 薬審第470号通知. 3) 厚生省薬務局(1989): 医薬品毒性試験法ガイドライン•生殖発生毒性試験, 薬審1第24号通知. 5) EC (1980): Reproduction studies, Official Journal of European Committee, No. C-355, vol. 23. 1) 田中悟(1994): 医薬品の生殖毒性検索のための試験法ガイドライン (薬審第470号通知) について, 医薬品研究, 25, 1037-1048. 6) ICH•Steering Committee (1993): ICH harmonised tripartite guideline on detection of toxicity to reproduction for medicinal products. 10) Takayama, S., Akaike, M., Kawashima, K., Takahashi, M. and Kurokawa, Y. (1995): A collaborative study in Japan on optimal treatment period and parameters for detection of male fertility disorders induced by drugs in rats., J. Am. Coll. Toxicol., 14, 266-292. 11) Takayama, S., Akaike, M., Kawashima, K., Takahashi, M. and Kurokawa, Y. (1995): studies on the optimal treatment period and parameters for detection of male f |
| References_xml | – reference: 3) 厚生省薬務局(1989): 医薬品毒性試験法ガイドライン•生殖発生毒性試験, 薬審1第24号通知. – reference: 7) 厚生省薬務局(1994): 医薬品の生殖毒性検索のための試験法ガイドライン, 薬審第470号通知. – reference: 10) Takayama, S., Akaike, M., Kawashima, K., Takahashi, M. and Kurokawa, Y. (1995): A collaborative study in Japan on optimal treatment period and parameters for detection of male fertility disorders induced by drugs in rats., J. Am. Coll. Toxicol., 14, 266-292. – reference: 1) 田中悟(1994): 医薬品の生殖毒性検索のための試験法ガイドライン (薬審第470号通知) について, 医薬品研究, 25, 1037-1048. – reference: 11) Takayama, S., Akaike, M., Kawashima, K., Takahashi, M. and Kurokawa, Y. (1995): studies on the optimal treatment period and parameters for detection of male fertility disorder in rats., J. Toxicol. Sci., 20, 173-182. – reference: 9) 田中悟, 他(1996): 医薬品の生殖発生毒性試験法ガイドライン (案), 医薬品規制ハーモナイゼーション推進国際共同研究•平成7年度厚生科学研究業績報告書, 98-117. – reference: 4) US-FDA (1966): Guidelines for reproduction studies for safety evaluation of drugs for human use. – reference: 5) EC (1980): Reproduction studies, Official Journal of European Committee, No. C-355, vol. 23. – reference: 6) ICH•Steering Committee (1993): ICH harmonised tripartite guideline on detection of toxicity to reproduction for medicinal products. – reference: 8) ICH Steering Committee (1995): Toxicity to male fertility•An addendum to the ICH tripartite guideline on detection of toxicity to reproduction for medicinal products, ICH•3, YOKOHAMA. – reference: 2) 黒川雄二(1996): ICH概説; 特にICH-3をめぐって, J. Toxicol. Sci., 21(2), App. 75-82. |
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| Title | ICH三極調整・医薬品生殖毒性試験法ガイドラインについて (Topics on Regulatory Toxicology (3)) |
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