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 *

932 related articles for article (PubMed ID: 16872240)

  • 1. 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]  

  • 2. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications.
    Tsintis P; La Mache E
    Drug Saf; 2004; 27(8):509-17. PubMed ID: 15154824
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Regulatory aspects of clinical trials in children.
    Mentzer D
    Arb Paul Ehrlich Inst Bundesinstitut Impfstoffe Biomed Arzneim Langen Hess; 2009; 96():203-7; discussion 207-9. PubMed ID: 20799462
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. The Internet and drug safety: what are the implications for pharmacovigilance?
    Cobert B; Silvey J
    Drug Saf; 1999 Feb; 20(2):95-107. PubMed ID: 10082068
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH).
    Bahri P; Tsintis P
    Pharmacoepidemiol Drug Saf; 2005 Jun; 14(6):377-87. PubMed ID: 15517542
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Evolving paradigms in pharmacovigilance.
    Brewster W; Gibbs T; Lacroix K; Murray A; Tydeman M; Almenoff J
    Curr Drug Saf; 2006 May; 1(2):127-34. PubMed ID: 18690923
    [TBL] [Abstract][Full Text] [Related]  

  • 8. 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]  

  • 9. The Erice Manifesto: for global reform of the safety of medicines in patient care.
    Drug Saf; 2007; 30(3):187-90. PubMed ID: 17343426
    [TBL] [Abstract][Full Text] [Related]  

  • 10. European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.
    Blake KV; Prilla S; Accadebled S; Guimier M; Biscaro M; Persson I; Arlett P; Blackburn S; Fitt H
    Pharmacoepidemiol Drug Saf; 2011 Oct; 20(10):1021-9. PubMed ID: 22039593
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.
    Lis Y; Roberts MH; Kamble S; J Guo J; Raisch DW
    Value Health; 2012 Dec; 15(8):1108-18. PubMed ID: 23244814
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both?
    Abraham J; Reed T
    Soc Sci Med; 2003 Jul; 57(2):195-204. PubMed ID: 12765701
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Industry perspectives on ICH guidelines.
    Rockhold FW
    Stat Med; 2002 Oct; 21(19):2949-57. PubMed ID: 12325111
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Development of a checklist for the assessment of pharmacovigilance guidelines in Southern Africa: a document review.
    Makhene NL; Steyn H; Vorster M; Lubbe MS; Burger JR
    Ther Adv Drug Saf; 2023; 14():20420986221143272. PubMed ID: 36713000
    [TBL] [Abstract][Full Text] [Related]  

  • 15. International Conference on Harmonisation; guidance on E2E Pharmacovigilance Planning; availability. Notice.
    Food and Drug Administration, HHS
    Fed Regist; 2005 Apr; 70(62):16827-8. PubMed ID: 15803631
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. [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]  

  • 18. 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]  

  • 19. 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]  

  • 20. Use of the dose, time, susceptibility (DoTS) classification scheme for adverse drug reactions in pharmacovigilance planning.
    Callréus T
    Drug Saf; 2006; 29(7):557-66. PubMed ID: 16808549
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 47.