[D1-A2] Advances and Challenges in Bioanalysis of Oligonucleotide Therapeutics

1:50 PM - 2:15 PM JST(4:50 AM - 5:15 AM UTC)

[D1-A2-02] PAC-LC-MS/MS Tissue Bioanalysis of Oligonucleotide Therapeutics: ICH M10–Based Validation and Multi-center Standardization

*Shin-ichiro Nitta¹, Yuchen Sun², Ryoya Goda³, Yuki Kishino⁴, Xiaoxi Liu⁵, Hisashi Fujita⁵, Masaaki Kakehi⁵, Yoshiharu Hayashi⁶, Satoshi Ito⁷, Tomomi Ishida⁸, Kiyomi Kikuchi⁸, Kazuko Inoue⁸, Kazutaka Shimbo⁹, Takeru Yamaguchi¹⁰, Fumihiro Jinno¹¹, Kaori Murakoshi¹², Kentaro Takahara¹³, Chie Murata¹⁴, Mitsuhiko Kawabata¹⁵, Kosuke Saito², Ruri Hanajiri², Yoshiro Saito² (1. Mediford Corporation, 2. National Institute of Health Sciences, 3. Future Peak Co., Ltd., 4. Daiichi Sankyo Co., Ltd., 5. Takeda Pharmaceutical Co., Ltd., 6. CMIC Pharma Science Co., Ltd., 7. Sekisui Medical Co., Ltd., 8. Eisai Co., Ltd., 9. Ajinomoto Co., Inc., 10. Sumika Chemical Analysis Service, Ltd., 11. Axcelead Drug Discovery Partners, Inc., 12. Tanabe Pharma Corporation, 13. Thermo Fisher Scientific K.K., 14. Ono Pharmaceutical Co., Ltd., 15. Shin Nippon Biomedical Laboratories, Ltd.)

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