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 *

241 related articles for article (PubMed ID: 30252199)

  • 1. The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates.
    Watanabe K; Murakami M; Masuyama K; Ishiguro C; Matsuda T
    Pharmacoepidemiol Drug Saf; 2018 Nov; 27(11):1265-1276. PubMed ID: 30252199
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Post-approval appending of CSARs to drug package inserts: an analysis of the types of adverse reactions and time to addition.
    Tamura N; Ishiguro C; Matsuda T
    Pharmacoepidemiol Drug Saf; 2015 Feb; 24(2):166-75. PubMed ID: 24737526
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post-approval in Japan.
    Saito R; Miyazaki S
    Pharmacol Res Perspect; 2023 Aug; 11(4):e01110. PubMed ID: 37365794
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Streamlining Considerations for Safety Measures: A Predictive Model for Addition of Clinically Significant Adverse Reactions to Japanese Drug Package Inserts.
    Watanabe T; Ambe K; Tohkin M
    Biol Pharm Bull; 2024; 47(3):611-619. PubMed ID: 38479885
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines.
    Hartford CG; Petchel KS; Mickail H; Perez-Gutthann S; McHale M; Grana JM; Marquez P
    Drug Saf; 2006; 29(8):657-73. PubMed ID: 16872240
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Factors distinguishing important identified risks from important potential risks in orphan and nonorphan drugs: An analysis of safety specifications of Japan and European Union risk management plans.
    Hirota S; Yamaguchi T
    Pharmacoepidemiol Drug Saf; 2018 Nov; 27(11):1231-1238. PubMed ID: 30187590
    [TBL] [Abstract][Full Text] [Related]  

  • 7. 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]  

  • 8. Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?
    Pacurariu AC; Hoeve CE; Arlett P; Genov G; Slattery J; Sturkenboom MCJM; Straus SMJM
    Pharmacoepidemiol Drug Saf; 2018 Feb; 27(2):168-173. PubMed ID: 29278866
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model.
    Watanabe T; Ambe K; Tohkin M
    Ther Innov Regul Sci; 2024 Mar; 58(2):357-367. PubMed ID: 38135862
    [TBL] [Abstract][Full Text] [Related]  

  • 10. The reorganisation of European pharmacovigilance. Part 2. From spontaneous reports to agency reviews and decisions.
    Prescrire Int; 2015 Feb; 24(157):50-4. PubMed ID: 25802924
    [TBL] [Abstract][Full Text] [Related]  

  • 11. An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance.
    Pinheiro LC; Candore G; Zaccaria C; Slattery J; Arlett P
    Pharmacoepidemiol Drug Saf; 2018 Jan; 27(1):38-45. PubMed ID: 29143393
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Factors associated with spontaneous reporting of adverse drug reactions in Japan.
    Yamada T; Watanabe Y; Kusama M; Sugiyama Y; Ono S
    Pharmacoepidemiol Drug Saf; 2013 May; 22(5):468-76. PubMed ID: 23172714
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.
    Arnardottir AH; Haaijer-Ruskamp FM; Straus SM; de Graeff PA; Mol PG
    Drug Saf; 2011 Nov; 34(11):1101-14. PubMed ID: 21981437
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks.
    Bloem LT; Karomi M; Hoekman J; van der Elst ME; Leufkens HGM; Klungel OH; Mantel-Teeuwisse AK
    Expert Opin Drug Saf; 2021 Nov; 20(11):1433-1442. PubMed ID: 34263667
    [No Abstract]   [Full Text] [Related]  

  • 15. A descriptive analysis of medicines safety advisories issued by national medicines regulators in Australia, Canada, the United Kingdom and the United States - 2007 to 2016.
    Perry LT; Bhasale A; Fabbri A; Lexchin J; Puil L; Joarder M; Mintzes B
    Pharmacoepidemiol Drug Saf; 2020 Sep; 29(9):1054-1063. PubMed ID: 32696556
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Application and optimisation of the Comparison on Extreme Laboratory Tests (CERT) algorithm for detection of adverse drug reactions: Transferability across national boundaries.
    Tham MY; Ye Q; Ang PS; Fan LY; Yoon D; Park RW; Ling ZJ; Yip JW; Tai BC; Evans SJ; Sung C
    Pharmacoepidemiol Drug Saf; 2018 Jan; 27(1):87-94. PubMed ID: 29108136
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Surveillance of drugs that most frequently induce acute kidney injury: A pharmacovigilance approach.
    Hosohata K; Inada A; Oyama S; Furushima D; Yamada H; Iwanaga K
    J Clin Pharm Ther; 2019 Feb; 44(1):49-53. PubMed ID: 30014591
    [TBL] [Abstract][Full Text] [Related]  

  • 18. [Direct reporting by patients of adverse drug reactions in Spain].
    Esther Salgueiro M; Jimeno FJ; Aguirre C; García M; Ordóñez L; Manso G
    Farm Hosp; 2013; 37(1):65-71. PubMed ID: 23461502
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Safety-Related Regulatory Actions and Risk Factors for Anticancer Drugs in Japan.
    Nakayama H; Matsumaru N; Tsukamoto K
    Pharmaceut Med; 2019 Feb; 33(1):45-52. PubMed ID: 31933266
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Ontological Organization and Bioinformatic Analysis of Adverse Drug Reactions From Package Inserts: Development and Usability Study.
    Li X; Lin X; Ren H; Guo J
    J Med Internet Res; 2020 Jul; 22(7):e20443. PubMed ID: 32706718
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 13.