BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

156 related articles for article (PubMed ID: 34987750)

  • 1. Effectiveness of drug postmarketing all-case surveillance as a safety measure in Japan.
    Kondo H; Masamune K
    Ther Adv Drug Saf; 2021; 12():20420986211065215. PubMed ID: 34987750
    [TBL] [Abstract][Full Text] [Related]  

  • 2. A Sponsor's Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan.
    Wolter KD; Kamatani A; Suzuki Y; Imaeda T; Dagher R; Safferman A; Junor R
    Pharmaceut Med; 2024 May; 38(3):217-224. PubMed ID: 38555545
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Current situation and issues regarding termination of risk management plans in Japan.
    Kameyama N; Hosaka A; Maeda H
    Front Med (Lausanne); 2024; 11():1387652. PubMed ID: 38873195
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation.
    Saito M; Iwasaki K
    J Artif Organs; 2017 Mar; 20(1):62-70. PubMed ID: 27709305
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999-2019.
    Nakao M; Nakamura Y; Shimokawa M; Maeda H
    Int J Clin Pharm; 2023 Feb; 45(1):108-116. PubMed ID: 36323961
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Postmarket safety communications on drugs approved in Japan: A 25-year analysis.
    Tanaka Y; Tanaka M; Miyazawa H; Terashima R; Miyazawa M; Ikuma M; Tomita Y
    Clin Transl Sci; 2024 Apr; 17(4):e13803. PubMed ID: 38651283
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Decision and timing of safety-related labeling changes for new drugs in Japan: Comparison with the United States and the European Union.
    Fukuda K; Narukawa M
    Pharmacoepidemiol Drug Saf; 2023 Dec; 32(12):1331-1340. PubMed ID: 37395168
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency.
    Ishiguro C; Misu T; Iwasa E; Izawa T
    Pharmacoepidemiol Drug Saf; 2017 Nov; 26(11):1314-1320. PubMed ID: 28722235
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance.
    Hirano Y; Asami Y; Kuribayashi K; Kitazaki S; Yamamoto Y; Fujimoto Y
    Value Health Reg Issues; 2018 May; 15():1-5. PubMed ID: 29474173
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.
    Borg JJ; Aislaitner G; Pirozynski M; Mifsud S
    Drug Saf; 2011 Mar; 34(3):187-97. PubMed ID: 21332243
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
    Salcher-Konrad M; Naci H; Davis C
    Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Characteristics of safety information obtained from postmarketing observational studies for re-examination in Japan.
    Watanabe T; Narukawa M
    Springerplus; 2016; 5(1):905. PubMed ID: 27386350
    [TBL] [Abstract][Full Text] [Related]  

  • 13. A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States.
    Hoshino Y; Narukawa M
    Pharmacoepidemiol Drug Saf; 2021 May; 30(5):561-572. PubMed ID: 33559352
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Does Industry-Conducted All-Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan?
    Suzuki A; Sato H; Sasaki Y
    Clin Transl Sci; 2019 Sep; 12(5):505-512. PubMed ID: 31062933
    [TBL] [Abstract][Full Text] [Related]  

  • 15. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
    Pflieger M; Bertram D
    Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval.
    Matsushita S; Tachibana K; Kusakabe T; Hirayama R; Tsutsumi Y; Kondoh M
    Clin Transl Sci; 2021 May; 14(3):806-811. PubMed ID: 33048440
    [TBL] [Abstract][Full Text] [Related]  

  • 17. SAFETY PROFILE OF OCRIPLASMIN FOR SYMPTOMATIC VITREOMACULAR ADHESION: A Comprehensive Analysis of Premarketing and Postmarketing Experiences.
    Hahn P; Chung MM; Flynn HW; Huang SS; Kim JE; Mahmoud TH; Sadda SR; Dugel PU
    Retina; 2015 Jun; 35(6):1128-34. PubMed ID: 25635575
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan.
    Shida H; Kajiyama K; Sawada S; Ishiguro C; Kubo M; Kimura R; Hirano M; Komiyama N; Iguchi T; Oniyama Y; Uyama Y
    Front Med (Lausanne); 2023; 10():1096992. PubMed ID: 36910503
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.
    Nagai S; Ozawa K
    Int J Hematol; 2016 Jul; 104(1):73-84. PubMed ID: 27084259
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.
    Jokura Y; Yano K; Yamato M
    J Tissue Eng Regen Med; 2018 Feb; 12(2):e1056-e1062. PubMed ID: 28211195
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.