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 *

319 related articles for article (PubMed ID: 30094558)

  • 1. EU pharmacovigilance regulatory requirements of anticancer biosimilar monoclonal antibodies.
    Francescon S; Fornasier G; Baldo P
    Int J Clin Pharm; 2018 Aug; 40(4):778-782. PubMed ID: 30094558
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Is pharmacovigilance of biologicals cost-effective?
    Claus B
    Int J Clin Pharm; 2018 Aug; 40(4):787-789. PubMed ID: 30051230
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective.
    Kurki P; Barry S; Bourges I; Tsantili P; Wolff-Holz E
    Drugs; 2021 Nov; 81(16):1881-1896. PubMed ID: 34596876
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Biosimilars: A consideration of the regulations in the United States and European union.
    Daller J
    Regul Toxicol Pharmacol; 2016 Apr; 76():199-208. PubMed ID: 26732800
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Current state of biologic pharmacovigilance in the European Union: improvements are needed.
    Felix T; Jordan JB; Akers C; Patel B; Drago D
    Expert Opin Drug Saf; 2019 Mar; 18(3):231-240. PubMed ID: 30714424
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions.
    Correia Pinheiro L; Giezen TJ; Wolff-Holz E; Weise M; Laslop A; Hidalgo-Simon A
    Clin Pharmacol Ther; 2021 Nov; 110(5):1311-1317. PubMed ID: 34472087
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.
    Bennett CL; Schoen MW; Hoque S; Witherspoon BJ; Aboulafia DM; Hwang CS; Ray P; Yarnold PR; Chen BK; Schooley B; Taylor MA; Wyatt MD; Hrushesky WJ; Yang YT
    Lancet Oncol; 2020 Dec; 21(12):e575-e588. PubMed ID: 33271114
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Biosimilars: A new scenario in biologic therapies.
    Serra López-Matencio JM; Morell Baladrón A; Castañeda S
    Reumatol Clin; 2017; 13(5):287-293. PubMed ID: 27372258
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Pharmacovigilance in China: development and challenges.
    Zhao Y; Wang T; Li G; Sun S
    Int J Clin Pharm; 2018 Aug; 40(4):823-831. PubMed ID: 30051225
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction.
    Ingrasciotta Y; Cutroneo PM; Marcianò I; Giezen T; Atzeni F; Trifirò G
    Drug Saf; 2018 Nov; 41(11):1013-1022. PubMed ID: 29796832
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Pharmacovigilance in Europe.
    Johnson CL; Hutchinson JA
    Transplantation; 2015 Aug; 99(8):1542-3. PubMed ID: 26308299
    [No Abstract]   [Full Text] [Related]  

  • 12. Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice.
    Vermeer NS; Giezen TJ; Zastavnik S; Wolff-Holz E; Hidalgo-Simon A
    Clin Pharmacol Ther; 2019 Apr; 105(4):962-969. PubMed ID: 30460997
    [TBL] [Abstract][Full Text] [Related]  

  • 13. EU's new pharmacovigilance legislation: considerations for biosimilars.
    Calvo B; Zuñiga L
    Drug Saf; 2014 Jan; 37(1):9-18. PubMed ID: 24190573
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Biologicals and biosimilars: safety issues in Europe.
    Portela MDCC; Sinogas C; Albuquerque de Almeida F; Baptista-Leite R; Castro-Caldas A
    Expert Opin Biol Ther; 2017 Jul; 17(7):871-877. PubMed ID: 28540760
    [TBL] [Abstract][Full Text] [Related]  

  • 15. 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]  

  • 16. Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.
    Kalaivani M; Singh A; Kalaiselvan V
    MAbs; 2015; 7(1):276-80. PubMed ID: 25523367
    [TBL] [Abstract][Full Text] [Related]  

  • 17. The Role of Disproportionality Analysis of Pharmacovigilance Databases in Safety Regulatory Actions: a Systematic Review.
    Dias P; Penedones A; Alves C; Ribeiro CF; Marques FB
    Curr Drug Saf; 2015; 10(3):234-50. PubMed ID: 26219291
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Pharmacovigilance in developing countries (part I): importance and challenges.
    Elshafie S; Zaghloul I; Roberti AM
    Int J Clin Pharm; 2018 Aug; 40(4):758-763. PubMed ID: 29248988
    [TBL] [Abstract][Full Text] [Related]  

  • 19. [The Polish Task Force position statement on safety of biologic treatment with monoclonal antibodies and soluble receptors].
    Jahnz-Rozyk K; Wiesik-Szewczyk E;
    Pol Merkur Lekarski; 2014 Jul; 37(217):5-9. PubMed ID: 25154192
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Biosimilars: A Multidisciplinary Perspective.
    Khraishi M; Stead D; Lukas M; Scotte F; Schmid H
    Clin Ther; 2016 May; 38(5):1238-49. PubMed ID: 26988243
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 16.