BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

233 related articles for article (PubMed ID: 33048367)

  • 1. Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.
    Tanaka M; Idei M; Sakaguchi H; Kato R; Sato D; Sawanobori K; Kawarasaki S; Hata T; Yoshizaki A; Nakamura M; Ikuma M
    Clin Pharmacol Ther; 2021 May; 109(5):1265-1273. PubMed ID: 33048367
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations.
    Tsuji K; Tsutani K
    J Clin Pharm Ther; 2010 Jun; 35(3):289-301. PubMed ID: 20848767
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved 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 Aug; 87(8):3279-3291. PubMed ID: 33511674
    [TBL] [Abstract][Full Text] [Related]  

  • 4. The notorious "drug lag" for oncology drugs in Japan.
    Yonemori K; Hirakawa A; Ando M; Hirata T; Yunokawa M; Shimizu C; Katsumata N; Tamura K; Fujiwara Y
    Invest New Drugs; 2011 Aug; 29(4):706-12. PubMed ID: 21286780
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Recent trends and success factors in reducing the lag time to approval of new drugs in Japan.
    Honig PK
    Clin Pharmacol Ther; 2014 May; 95(5):467-9. PubMed ID: 24747231
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?
    Maeda H; Kurokawa T
    Int J Clin Oncol; 2015 Dec; 20(6):1072-80. PubMed ID: 25837976
    [TBL] [Abstract][Full Text] [Related]  

  • 7. A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018.
    Sumi E; Asada R; Lu Y; Ito-Ihara T; Grimes KV
    Clin Ther; 2020 Feb; 42(2):305-320.e0. PubMed ID: 32008723
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Regulatory review time for approval of oncology drugs in Japan between 2001 and 2014. Considerations of changes, factors that affect review time, and difference with the United States.
    Maeda H; Kurokawa T
    J Clin Pharmacol; 2015 May; 55(5):481-9. PubMed ID: 25560978
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Notable Differences in Drug Lag Between Korea and Japan of New Drugs Between 2009 and 2017.
    Lee SW; Park SH; Song I; Noh Y; Park H; Ha D; Shin JY
    Ther Innov Regul Sci; 2020 Mar; 54(2):418-423. PubMed ID: 32072585
    [TBL] [Abstract][Full Text] [Related]  

  • 10. An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004-2018).
    Konwar M; Maurya MR; Nishandar TB; Thatte UM; Gogtay NJ
    Perspect Clin Res; 2021; 12(3):159-164. PubMed ID: 34386381
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials.
    Ushijima S; Matsumaru N; Tsukamoto K
    Pharmaceut Med; 2021 Jul; 35(4):253-260. PubMed ID: 34291425
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Clinical development and review times for new drugs in Japan: associated factors.
    Ishibashi T; Yasuda K; Kusama M; Sugiyama Y; Ono S
    Clin Pharmacol Ther; 2010 Oct; 88(4):487-91. PubMed ID: 20739921
    [TBL] [Abstract][Full Text] [Related]  

  • 13. [Investigation on new molecular entities of drugs approved in three regions, Japan, U.S. and EU--common and preceding approvals in current 4 years].
    Saito M; Hirata-Koizumi M; Miyake S; Hasegawa R
    Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2006; (124):80-2. PubMed ID: 17405529
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Oncology drug lag in Japan: has it improved over the last decade?
    Tachibana Y; Narukawa M
    Int J Clin Oncol; 2023 Nov; 28(11):1451-1460. PubMed ID: 37561368
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Assessment of the Delay in Novel Anticancer Drugs between China and the United States: A Comparative Study of Drugs Approved between 2010 and 2021.
    Luo X; Du X; Li Z; Qian F; Yang Y
    Clin Pharmacol Ther; 2023 Jan; 113(1):170-181. PubMed ID: 36151921
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Analysis of 10 years drug lifecycle management (LCM) activities in the Japanese market.
    Hashitera Y; Saotome C; Yamamoto H
    Drug Discov Today; 2013 Nov; 18(21-22):1109-16. PubMed ID: 23856327
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Assessing drug lag in new drug approvals by the Iran Food and Drug Administration compared to the U.S. FDA, EMA, and PMDA: A 20-year analysis (2001-2021).
    Alipour S; Nadimi Parashkouhi S; Mojahedian M; Abbasian H
    Medicine (Baltimore); 2024 Jun; 103(25):e38142. PubMed ID: 38905367
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Reforms of regulatory pathways for approval of new antineoplastic drugs in Japan from 2004 to 2019 and accompanying changes in pivotal clinical trial designs.
    Hirai T; Suzuki A; Yamori T; Matsuura M
    Invest New Drugs; 2022 Feb; 40(1):142-150. PubMed ID: 34417913
    [TBL] [Abstract][Full Text] [Related]  

  • 19. 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]  

  • 20. Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.
    Kuribayashi R; Nakano A; Hariu A; Kishioka Y; Honda F
    BioDrugs; 2023 Jul; 37(4):443-451. PubMed ID: 37227657
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 12.