​​2018~

1. Hara, T.; Sato, Y.; Tanishiro, H.; Tamaki, Y.; Baba, S.; Hirose, E.; Yoshida, B.; Watanabe, K.; Nishikawa, G.; Okuda, D.; Murakami, M.; Niwa, Y.; Kondoh, M. Principles for evaluating the efficacy and safety of ceramic dental implants in Japan. Ther. Innov. Regul Sci., in press.

2. Ishibashi, K.; Kusakabe, T.; Kondoh, M. Current Application of the Medical Device Single Audit Program (MDSAP) as a Global Regulatory Reliance Framework for the Inspection of Medical Devices. Ther. Innov. Regul Sci., in press.

3. Hosono, T. ; Niwa, Y.; Kondoh, M.　Comparison of product features and clinical trial designs for the DTx products with the indication of insomnia authorized by regulatory authorities, Ther. Innov. Regul Sci., in press.

4. Tachibana, K.; Bai, L.; Sugimura, S.; Fujioka H.; Kishimoto, W.; Mizuguchi, H.; Nakase, H.; Kondoh, M. Heterogenous gene expression of bicellular and tricellular tight junction–sealing components in the human intestinal tract, Biol Pharm Bull, 2024, 1209-1217.

5. Tachibana, K.; Hirayama, R.; Sato, N.; Hattori, K.; Kato, T.; Takeda, H.; Kondoh, M. Association of plasma claudin-5 with age and Alzheimer disease, Int J Mol Sci, 2024, 25, 1419.

6. 庄真喜子、太田翔平、橘敬祐、近藤昌夫、腸内細菌による薬物代謝を考慮したレギュレーションの現状と課題、レギュラトリーサイエンス学会誌, 2024, 14, 81-90.

7. Hosomi, K.; Shimoyama, A.; Hinenoya, A.; Hatanaka, N.; Noguchi, T.; Ebina, H.; Tojima, Y.; Furuta, M.; Kondoh, M.; Kiyono, H.; Yamasaki, S.; Fukase, K.; Kunisawa, J. Endotoxin-free Stx2B-C-CPE vaccine and its optimized adjuvant regimen for preventing food poisoning. Front Biosci (Landmark Ed), 2023, 28, 15. 

8. Fujiwara-Tani, R.; Mori, S.; Ogata, R.; Sasaki, R.; Ikemoto, A.; Kishi, S.; Kondoh, M.; Kuniyasu, H. Claudin-4: A new molecular target for epithelial cancer therapy. Int J Mol Sci, 2023, 24, 5494. 

9. Kurauchi, M.; Sato, Y.; Tanishiro, H.; Morita, R.; Otsuki, M.; Kaneko, J.; Tsubaki, T.; Yoshida, B.; Aso, K.; Murakami, M.; Kondoh, M. A Japanese concept of considerations for evaluation of dental materials for tooth bleaching. J. Dent. Sci. Rev., 2023, 59, 23-27. 

10. 橘敬祐、近藤昌夫、再生医療イノベーションプラットフォーム：再生医療等製品承認制度、実験医学、2023, 41, 183-192.

11. Ishimoto, K.; Arafune, T.; Washio, T.; Haishima, Y.; Matsumoto, K.; Uematsu, M.; Nomura, Y.; Yokoi, H.; Sato, H.; Murakami, M.; Okazaki, Y.; Tachibana, K.; Kondoh, M. (Co-corresponding author) Japanese regulatory considerations for interoperability of medical devices. Ther. Innov. Regul Sci., 2023, 57, 104-108.

12. 白霖、桂田剛志、橘敬祐、日下部哲也、堤康央、近藤昌夫、粘膜吸収促進剤の安全性評価の現状と課題、レギュラトリーサイエンス学会誌、2023, 13, 1-14.

13. Shirasago, Y.; Fukazawa, H.; Nagase, S.; Shimizu, Y.; Wakita, T.; Suzuki, T.; Tani, H.; Kondoh, M.; Kuroda T.; Yasuda S.; Sato, Y.; Hanada, K.; Fukasawa, M. A single mutation in the E2 glycoprotein of hepatitis C virus broadens the claudin specificity for its infection, Sci Rep, 2022, 12, 20243. 

14. Bai, L.; Tachibana, K.; Murata, M.; Inoue, T.; Mizuguchi, H.; Maeda, S.; Ikemura, K.; Okuda, M.; Kusakabe, T.; Kondoh, M. A doxycycline-inducible CYP3A4-Caco-2 cell line as a model for evaluating safety of aflatoxin B1 in the human intestine, Toxiocol Lett, 2022, 370, 1-6.

15. Hashimoto, R.; Takahashi, J.; Shirakura, K.; Funatsu, R.; Kosugi, K.; Deguchi, S.; Yamamoto, M.; Tsunoda, Y.; Morita, M.; Muraoka, K.; Tanaka, M.; Kanbara, T.; Tanaka, S.; Tamiya, S.; Tokunoh, N.; Kawai, A.; Ikawa, M.; Ono, C.; Tachibana, K.; Kondoh, M.; Obana, M.; Matsuura, Y.; Ohsumi, A.; Noda, T.; Yamamoto, T.; Yoshioka, Y.; Torisawa, Y.; Date, H.; Fujio, Y.; Nagao, M.; Takayama, K.; Okada, Y. SARS-CoV-2 disrupts respiratory vascular barriers by suppressing claudin-5 expression, Sci. Adv., 2022, 8, eabo6783.

16. Saito, K.; Konno, T.; Kohno, T.; Shimada, H.; Matsuura, M.; Okada, T.；Kura, A.; Ishii, D.; Kondoh, M.; Saito, T.; Kojima T. LSR antibody promotes apoptosis and disrupts epithelial permeability barriers via signal transduction pathways in endometrial cancer. Tissue Barrier,  2022, 26, 2106113.

17. Wakayama, E.; Kuzu, T.; Tachibana, K.; Hirayama, R.; Okada, Y.; Kondoh, M.  Modifying the blood–brain barrier by targeting claudin-5; safety and risks. Ann. N. Y. Acad. Sci, 2022, 14, 62-69.

18. Noguchi, T.; Tachibana, K.; Inoue, T.; Sakai, T.; Tsujikawa, K.; Fujio, Y.; Yamagishi, Y.; Hamaguchi, S.; Kutsuna, S.; Kondoh, M. Safety evaluation of MA-T after ingestion in mice. Toxicology, 2022, 477, 153254.

19. Maesaka, F.; Kuwada, M.; Horii, S.; Kishi, S.; Fujiwara-Tani, R.; Mori, S.; Fujii, K.; Mori, T.; Ohmori, H.; Owari, T.; Miyake, M.; Nakai, Y.; Tanaka, N.; Bhawal, U.; Luo, Y.; Kondoh, M.; Fujimoto, K.; Kuniyasu, H. Hypomethylation of CLDN4 gene promoter is associated with malignant phenotype in urinary bladder cancer. Int J Mol Sci, 2022, 23, 6516. 

20. Watari, A.; Fujiwara, K.; Yagi, K.; Tachibana, K.; Katsurada, T.; Myoui, A.; Kondoh, M. Homoharringtonine is a transdermal granular permeation enhancer. Biochem Biophys Res Commun, 2022, 616, 140-144.

21. Shimizu, Y.; Suzuki, T.; Shirasago,Y.; Kondoh, M.; Suzuki, T.; Wakita, T.; Fukasawa, M. Antiviral effects of the anti-occludin monoclonal antibody on persistent hepatitis C virus infection in a human liver chimeric mouse model. BPB Reports,2021, 4, 142-147.

22. Hashimoto, Y.; Campbell, M.; Tachibana, K.; Okada, Y.; Kondoh, M. Claudin-5: A Pharmacological Target to Modify the Permeability of the Blood-Brain Barrier. Biol Pharm Bull, 2021, 44, 1380-1390.

23. Ohwada, K.; Knno, T.; Kohno, T.; Nakano, M.; Ohkuni, T.; Miyata, R.; Kanuki, T.; Kondoh, M.; Takano, K.; Kojima, T. Effects of HMGB1 on tricellular tight junctions via TGF-β signaling in human nasal epithelial cells. Int J Mol Sci, 2021, 22, 8390.

24. Kohno, T.; Konno T.; Kikuchi, S.; Kondoh, M.; Kojima, T. Translocation of LSR from tricellular corners causes macropinocytosis at cell-cell interface as a trigger for breaking out of contact inhibition. FASEB J, 2021, 35, e21742.

25. Tachibana, K.; Hashimoto, Y.; Shirakura, K.; Okada, Y.; Hirayama, R.; Iwashita, Y.; Nishino, I.; Ago, Y.; Takeda, H.; Kuniyasu, H.; Kondoh, M. Safety and efficacy of an anti-claudin-5 monoclonal antibody to increase blood–brain barrier permeability for drug delivery to the brain in a non-human primate. J Control Release, 2021, 336, 105-111. 

26. 近藤昌夫、基礎研究者（イノベーター）とレギュレーションの出会い、Biophilia, 2021, 36, 4-5.

27. 近藤昌夫、医療における薬事レギュレーションと創薬イノベーションの関係、Biophilia, 2021, 36, 6-11.

28. Castro Dias, M.; Quesada, A.O.; Soldati, S.; Boesch, F.; Gruber, I.; Hildbrand, T.; Soenmez, D.; Khire, T.; Witz, G.; McGrath, J.L.; Piontek, J.; Kondoh, M.; Deutsch, U.; Zuber, B.; Engelhardt, B. Brain endothelial tricellular junctions as novel sites for T-cell diapedesis across the blood-brain barrier. J Cell Sci, 2021, 134, jcs253880.

29. Takamura, K.; Tachibana, K.; Kihira, T.; Nakai, K.; Tsutsumi, Y.; Kondoh, M. Legislation on the roles of the Pharmacist and Pharmacy in the revision of the Pharmaceutical and Medical Device Act and the Pharmacists Act in Japan.Ther Innov Regul Sci, 2021, 55, 304-308. 

30. Tachibana, K.; Kondoh, M. A method to prepare a bioprobe for regulatory science of drug delivery system to the brain: an angulin binder to modulate tricellular tight junction-seal. Methods Mol Biol, 2021, 2367, 291-304.

31. Matsushita, S.; Tachibana, K.; Kusakabe, T.; Hirayama, R.; Tsutsumi, Y.; Kondoh, M. Overview of the pre- and post-marketing requirements for drugs granted Japanese conditional marketing approval. Clin Transl Sci, 2021, 14, 806-811.

32. Shimizu, Y.; Shinoda, T.; Shirasago, Y.; Kondoh, M.; Shinya, N.; Harada, K.; Yagi, K.; Suzuki, T.; Wakita, T.; Kimura-Someya, T.; Shirouz, M.; Fukasawa, M. Occludin-binding single-chain variable fragment and antigen-binding fragment antibodies prevent hepatitis C virus infection. FEBS Lett, 2021, 595, 220-229.

33. Tachibana, K.; Iwashita, Y.; Wakayama, E.; Nishino, I.; Nishikaji, T.; Kondoh, M. Tight junction modulating bioprobes for drug delivery system to the brain. Pharmaceutics, 2020, 12, 1236. 

34. Matsushita, S.; Tachibana, K.; Kusakabe, T.; Hirayama, R.; Tsutsumi, Y.; Kondoh, M. The roadmap to approval under Japan’s two track regulatory system: comparing six regenerative medical products. Cell Stem Cell, 2020, 27, 515-518．

35. 太田和、橘敬祐、日下部哲也、近藤昌夫、市販後に性能が変わりうる医療機器のレギュラトリーサイエンス、レギュラトリーサイエンス学会誌, 2020, 10, 131-137.

36. Owari, T.; Sasaki, T.; Fujii, K.; Fujiwara-Tani, R.; Kishi, S.; Mori, S.; Mori, T.; Goto, K.; Kawahara, I.; Nakai, Y.; Miyake, M.; Luo, Y.; Tanaka, N.; Kondoh, M.; Fujimoto, K.; Kuniyasu, H. Role of nuclear claudin-4 in renal cell carcinoma. Int J Mol Sci, 2020, 21, 8340.

37. Torres, J.B.: Mosley, M.; Koustoulidou, S.; Hopkins, S.; Knapp, S.; Chaikuad, A.; Kondoh, M.; Tachibana, K.; Kersemans, V.; Cornelissen, B. Radiolabeled cCPE Peptides for SPECT Imaging of Claudin-4 Overexpression in Pancreatic Cancer. J Nucl Med, 2020, 61, 1756-1763.

38. Shimizu, Y.; Isoda, K.; Taira, Y.; Taira, I.; Kondoh, M.; Ishida, I. Anti-tumor effect of a recombinant Bifidobacterium strain secreting claudin-targeting molecule in mouse breast cancer model. Eur J Pharmacol, 2020, 887, 173596.

39. Fujiwara-Tani, R.; Sasaki, T.; Fujii, K.; Luo, Y.; Mori, T.; Kishi, S.; Mori, S.; Matsushima-Otsuka, S.; Nishiguchi, Y.; Goto, K.; Kawahara, I.; Kondoh, M.; Sho, M.; Kuniyasu, H. Diabetes mellitus is associated with liver metastasis of colorectal cancer through production of biglycan-rich cancer stroma. Oncotarget, 2020, 11, 2982-2994.

40. Fujiwara-Tani, R.; Fujii, K.; Mori, S.; Kishi, S.; Sasaki, T.; Ohmori, H.; Nakashima, C.; Kawahara, I.; Nishiguchi, Y.; Mori, T.; Sho, M.; Kondoh, M.; Luo, Y.; Kuniyasu, H. Clostridium perfringens enterotoxin induces claudin-4 to activate YAP in colonic sessile serrated adenoma/polyp with dysplasia. Int J Mol Sci, 2020, 21, E3840.

41. Takamura, K.; Tachibana, K.; Kusakabe, T.; Nakai, K.; Tsutsumi, Y.; Kondoh, M. New Japanese Regulatory Frameworks for Post-marketing Management of Pharmaceutical Products. Pharm Res, 2020, 37, 122.

42. Hashimoto, Y.; Tachibana, K.; Kondoh, M. Tight junction modulators for drug delivery to the central nervous system. Drug Discov Today, 2020, 25, 1477.

43. Luo, Y.; Kishi, S.; Sasaki, T.; Ohmori, H.; Fujiwara-Tani, R.; Mori, S.; Goto, K.; Nishiguchi, Y.; Mori, T.; Kawahara, I.; Kondoh, M.; Kuniyasu, H. Targeting claudin-4 enhances chemosensitivity in breast cancer. Cancer Sci, 2020, 111, 184.

44. Tachibana, K.; Kondoh, M . Therapeutic innovation and regulation for paracellular absorption enhancers for biologics. Drug Delivery System, 2020, 35, 20－26. 

45. Tachibana, K.; Kondoh, M. A method to prepare claudin modulating recombinant proteins, Methods Mol Biol, 2020, 2109, 251.

46. Konno, T.; Kohno, T.; Kikuchi, S.; Shimada, H.; Satohisa, S.; Saito, T.; Kondoh, M.; Kojima, T. Epithelial barrier dysfunction and cell migration induction via JNK/cofilin/actin by angubindin-1. Tissue Barriers, 2020, 8, 1695475.

47. Nakashima, C.; Yamamoto, K.; Kishi, S.; Sasaki, T.; Ohmori, H.; Fujiwara-Tani, R.; Mori, S.; Kawahara, I.; Nishiguchi, Y.; Mori, T.; Kondoh, M.; Luo, Y.; Kirita, T.; Kuniyasu, H. Clostridium perfringens enterotoxin induces claudin-4 to activate YAP in oral squamouse cell carcinoma. Oncotarget, 2020, 11, 309-321. 

48. Kyuno, T.; Kyuno, D.; Kohno, T.; Konno, T.; Kikuchi, S.; Arimoto, C.; Yamaguchi, H.; Imamura, M.; Kimura, Y.; Kondoh, M.; Takemasa, I.; Kojima, T. Tricellular tight junction protein LSR/angulin-1 contributes to the epithelial barrier and malignancy in human pancreatic cancer cell line. Histochem Cell Biol, 2020, 153, 5-16.

49. Hashimoto, Y.; Tachibana, K.; Krug, S.M.; Kunisawa, J.; Fromm, M.; Kondoh, M. Potential for tight junction protein-directed drug development using claudin binders and angubindin-1. Int J Mol Sci, 2019, 20, 4016.

50. 橘敬祐、近藤昌夫、上皮を標的とした創薬イノベーションとレギュラトリーサイエンス, ファルマシア, 2019, 55, 522-526.​

51. Hashimoto, Y.; Kondoh, M.; Takeda, H. Development of drug delivery system for treatment of central nervous system diseases targeting tight junctions. Drug Delivery System, 2019, 34, 374－384. 

52. Kondoh, M. Interpenetration of innovation and regulation for drug development. Drug Delivery System, 2019, 34, 333. 

53. Kondoh, M. Development of drug delivery system based on biology of epithelial barrier. Drug Delivery System, 2019, 34, 279－283. 

54. Matsushita, S.; Tachibana, K.; Nakai, K.; Sanada, S.; Kondoh, M.  A review of the regulatory framework for initiation and acceleration of patient access to innovative medical products in Japan. Clin Pharmacol Ther, 2019, 106, 508-511.

55. Hashimoto, Y.; Okada, Y.; Shirakura, K.; Tachibana, K.; Sawada, M.; Yagi, K.; Doi, T.; Kondoh, M. Anti-claudin antibodies as a concept for development of claudin-directed drugs. J Pharmacol Exp Ther, 2019, 368, 179-186.

56. Matsushita, S.; Tachibana, K.; Kondoh, M. The clinical innovation network: A policy for promoting development of drugs and medical devices in Japan. Drug Discov Today, 2019, 24, 4-8.

57. Sasaki, T.; Fujiwara-Tani, R.; Kishi, S.; Mori, S.; Luo, Y.; Goto, K.; Ohmori, H.; Kawahara, I.; Goto, K.; Nishiguchi, Y.; Mori, T.; Sho, M.; Kondoh, M.; Kuniyasu, H. Targeting claudin-4 enhances chemosensitivity of pancreatic ductal carcinomas. Cancer Med, 2019, 8, 6700-6708. 

58. Shimizu, Y.; Shirasago, Y.; Suzuki, T.; Hata, T.; Kondoh, M.; Hanada, K.; Yagi, K.; Fukasawa, M. Characterization of monoclonal antibodies recognizing each extracellular loop domain of occludin. J Biochem, 2019, 166, 297-308. 

59. Shimizu, Y.; Yoneda, K.; Shirasago, Y.; Suzuki, Ta.; Tada, M.; Ishii-Watabe, A.; Sugiyama, K.; Suzuki, Te.; Wakita, T.; Yagi, K.; Kondoh, M.; Fukasawa, M.  Human-rat chimeric anti-occludin monoclonal antibodies inhibit hepatitis C virus infection. Biochem Biophys Res Commun, 2019, 514, 785. 

60. Tachibana, K.; Kondoh, M. Perspectives on tight junctions-related skin diseases and their pharmaceutical affairs. Drug Delivery System, 2018, 33, 268-272.

61. Hashimoto, Y.; Zhou, W.; Hamauchi, K.; Shirakura, K.; Doi, T.; Yagi, K.; Sawasaki, T.; Okada, Y.; Kondoh, M.; Takeda, H. Engineered membrane protein antigens successfully induce antibodies against extracellular regions of claudin-5. Sci Rep, 2018, 8, 8383.

62. Zeniya, S.; Kuwahara, H.; Daizo, K.; Watari, A.; Kondoh, M.; Yoshida-Tanaka, K.; Kaburagi, H.; Asada, K.; Nagata, T.; Nagahama, M.; Yagi, K.; Yokota, T. Angubindin-1 opens the blood-brain barrier in vivo for delivery of antisense oligonucleotide to the central nervous system. J Control Release, 2018, 283, 126-134.

63. Tachibana, K.; Yuzuriha, T.; Tabata, R.; Fukuda, S.; Maegawa, T.; Takahashi, R.; Tanimoto, K.; Tsujino, H.; Nunomura, K.; Lin, B.; Matsuura, Y.; Tanaka, T.; Hamakubo, T.; Sakai, J.; Kodama, T.; Kobayashi, T.; Ishimoto, K.; Miyachi, H.; Doi, T. Discovery of peroxisome proliferator–activated receptor α (PPARα) activators with a ligand-screening system using a human PPARα-expressing cell line. J Biol Chem, 2018, 293, 10333-10343.

64. Shimo, T.; Tachibana, K.; Obika, S. Construction of a tri-chromatic reporter cell line for the rapid and simple screening of splice-switching oligonucleotides targeting DMD exon 51 using high content screening. PLoS One, 2018, 13, e0197373.

65. Hashimoto, Y.; Hata, T.; Tada, M.; Iida, M.; Watari, A.; Okada, Y.; Doi, T.; Kuniyasu, H.; Yagi, K.; Kondoh, M. Safety evaluation of a human chimeric monoclonal antibody that recognizes the extracellular loop domain of claudin-2. Eur J Pharmacol Sci, 2018, 117, 161-167.

66. Shimizu, Y.; Shirasago, Y.; Kondoh, M.; Suzuki, T.; Wakita, T.; Hanada, K.; Yagi, K.; Fukasawa, M. Monoclonal antibodies against occludin completely prevented hepatitis C virus infection in a mouse model. J Virol, 2018, 82, e02256-17.

67. Suzuki, H.; Nagatake, T.; Nasu, A.; Lan, H.; Ikegami, K.; Setou, M.; Hamazaki, Y.; Kiyono, H.; Yagi, K.; Kondoh, M.; Kunisawa, J. Impaired airway mucociliary function reduces antigen-specific IgA immune response to immunization with a claudin-4-targeting nasal vaccine in mice. Sci Rep, 2018, 8, 2904.

68. Matsuhisa, K.; Watari, A.; Iwamoto, K.; Kondoh,M.; Yagi, K. Lignosulfonic acid attenuates NF-κB activation and intestinal epithelial barrier dysfunction induced by TNF-α/IFN-γ in Caco-2 cells. J Nat Med, 2018, 72, 448-455.

​

​

​

​