論文 - 詳細
| RRC ID | 51906 |
|---|---|
| 著者 | Saito KI, Inoue Y, Ikegami Y, Nanbo I, Onozuka M, Sano K, Yoshida H, Sakamoto T, Tatebayashi E, Fujita KI, Sasaki Y, Kitazawa T. |
| タイトル | Investigation of Bioequivalence Between Brand-name and Generic Irinotecan Products. |
| ジャーナル | Anticancer Res |
| Abstract |
BACKGROUND/AIM:To investigate bioequivalence among generic and brand-name irinotecan products. MATERIALS AND METHODS:Products of Yakult and Daiichi-Sankyo (brand-name products), Sandoz, Nippon Kayaku, Taiho, and Sawai were compared with respect to their composition and antitumor activity. RESULTS:High-performance liquid chromatography demonstrated that related substances were within the acceptable range. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay revealed significant differences in cytotoxicity for four cancer cell lines among the products. The concentration of the active compound SN-38 was highest in Yakult's product (23.82 ng/ml) and lowest in Daiichi-Sankyo's product (8.96 ng/ml). MTT assay data were correlated with the SN-38 concentration, suggesting that it influenced differences in cytocidal activity among products. However, the SN-38 concentration was far lower than that of irinotecan (20 mg/ml), suggesting a negligible clinical effect. Metabolism of irinotecan to SN-38 or open-ring forms did not differ significantly among the products. CONCLUSION:The generic products showed equivalent efficacy and safety to the brand-name products. |
| 巻・号 | 36(11) |
| ページ | 5957-5963 |
| 公開日 | 2016-11-1 |
| DOI | 10.21873/anticanres.11183 |
| PII | 36/11/5957 |
| PMID | 27793921 |
| MeSH | Antineoplastic Agents, Phytogenic / pharmacokinetics* Camptothecin / analogs & derivatives* Camptothecin / pharmacokinetics Cell Line, Tumor Chromatography, High Pressure Liquid Drugs, Generic / pharmacokinetics* Humans Irinotecan Therapeutic Equivalency |
| IF | 1.994 |
| 引用数 | 0 |
| リソース情報 | |
| ヒト・動物細胞 | NIH:OVCAR-3(RCB2135) |