@article {SAITO5957, author = {KEN-ICHI SAITO and YUTAKA INOUE and YOJI IKEGAMI and IZUMI NANBO and MARI ONOZUKA and KAZUMI SANO and HISAHIRO YOSHIDA and TOSHIHIRO SAKAMOTO and EMI TATEBAYASHI and KEN-ICHI FUJITA and YASUTSUNA SASAKI and TAKAKI KITAZAWA}, title = {Investigation of Bioequivalence Between Brand-name and Generic Irinotecan Products}, volume = {36}, number = {11}, pages = {5957--5963}, year = {2016}, publisher = {International Institute of Anticancer Research}, 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{\textquoteright}s product (23.82 ng/ml) and lowest in Daiichi-Sankyo{\textquoteright}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.}, issn = {0250-7005}, URL = {https://ar.iiarjournals.org/content/36/11/5957}, eprint = {https://ar.iiarjournals.org/content/36/11/5957.full.pdf}, journal = {Anticancer Research} }