These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

383 related articles for article (PubMed ID: 30528048)

  • 1. Current Trends in Clinical Development of Gene and Cellular Therapeutic Products for Cancer in Japan.
    Nagai S; Sugiyama D
    Clin Ther; 2019 Jan; 41(1):174-184.e3. PubMed ID: 30528048
    [TBL] [Abstract][Full Text] [Related]  

  • 2. New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products.
    Nagai S; Ozawa K
    Curr Gene Ther; 2017; 17(1):17-28. PubMed ID: 28382858
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.
    Nagai S
    Int J Mol Sci; 2019 Aug; 20(15):. PubMed ID: 31382625
    [TBL] [Abstract][Full Text] [Related]  

  • 4. [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].
    Sato Y
    Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2014; (132):6-9. PubMed ID: 25707195
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Preclinical Toxicity Studies for Regenerative Medicine in Japan.
    Shigeto J; Ichiki T; Nii T; Konno K; Nakanishi Y; Sugiyama D
    Clin Ther; 2018 Nov; 40(11):1813-1822. PubMed ID: 30458928
    [TBL] [Abstract][Full Text] [Related]  

  • 6. The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States.
    Kondo H; Hata T; Ito K; Koike H; Kono N
    Ther Innov Regul Sci; 2017 Jan; 51(1):51-54. PubMed ID: 30235998
    [TBL] [Abstract][Full Text] [Related]  

  • 7. [Current status of the regulation and development of cell therapy products in Japan].
    Igarashi Y; Sato Y
    Nihon Yakurigaku Zasshi; 2018; 151(6):254-259. PubMed ID: 29887575
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Achievements and challenges of the Sakigake designation system in Japan.
    Tanaka M; Idei M; Sakaguchi H; Kato R; Sato D; Sawanobori K; Kawarasaki S; Hata T; Yoshizaki A; Nakamura M; Ikuma M
    Br J Clin Pharmacol; 2021 Oct; 87(10):4027-4035. PubMed ID: 33694268
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Regulatory Frameworks for Gene and Cell Therapies in Japan.
    Maeda D; Yamaguchi T; Ishizuka T; Hirata M; Takekita K; Sato D
    Adv Exp Med Biol; 2015; 871():147-62. PubMed ID: 26374217
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan.
    Okada K; Koike K; Sawa Y
    Regen Ther; 2015 Jun; 1():80-83. PubMed ID: 31245444
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Regulatory Issues: PMDA - Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma.
    Maruyama Y; Sakurai A; Noda S; Fujiwara Y; Okura N; Takagi T; Asano J; Honda F
    Oncologist; 2023 Aug; 28(8):664-670. PubMed ID: 36917020
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Regulatory Aspects of Cell and Gene Therapy Products: The Japanese Perspective.
    Maruyama Y; Noda S; Okudaira S; Sakurai A; Okura N; Honda F
    Adv Exp Med Biol; 2023; 1430():155-179. PubMed ID: 37526847
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Regenerative medicine legislation in Japan for fast provision of cell therapy products.
    Fujita Y; Kawamoto A
    Clin Pharmacol Ther; 2016 Jan; 99(1):26-9. PubMed ID: 26482927
    [TBL] [Abstract][Full Text] [Related]  

  • 14. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
    Coppens DGM; de Wilde S; Guchelaar HJ; De Bruin ML; Leufkens HGM; Meij P; Hoekman J
    Cytotherapy; 2018 Jun; 20(6):769-778. PubMed ID: 29730080
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies.
    Azuma K; Yamanaka S
    Regen Ther; 2016 Jun; 4():36-47. PubMed ID: 31245486
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Regulatory and clinical development to support the approval of advanced therapies medicinal products in Japan.
    Carolina IL; Antònia A; Mercè O; Antonio V
    Expert Opin Biol Ther; 2022 Jul; 22(7):831-842. PubMed ID: 35762253
    [TBL] [Abstract][Full Text] [Related]  

  • 17. The ideal way to design clinical trials and establishment of evidence for human cellular and tissue-based products in Japan.
    Sawa Y
    J Tissue Eng Regen Med; 2019 Jun; 13(6):905-907. PubMed ID: 30938062
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products.
    Hayakawa T; Harris I; Joung J; Kanai N; Kawamata S; Kellathur S; Koga J; Lin YC; Maruyama Y; McBlane J; Nishimura T; Renner M; Ridgway A; Salmikangas P; Sakamoto N; Sato D; Sato Y; Toda Y; Umezawa A; Werner M; Wicks S
    Biologicals; 2016 Sep; 44(5):467-79. PubMed ID: 27461129
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan.
    Inokuma Y
    Drug Saf; 2017 Jun; 40(6):475-482. PubMed ID: 28299610
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Regulatory perspectives of Japan.
    Kusakabe T
    Biologicals; 2015 Sep; 43(5):422-4. PubMed ID: 26028474
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 20.