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 *

131 related articles for article (PubMed ID: 28570569)

  • 21. Lessons learned from independent central review.
    Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
    Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
    [TBL] [Abstract][Full Text] [Related]  

  • 22. Clinical and regulatory features of drugs not initially approved by the FDA.
    Wang B; Avorn J; Kesselheim AS
    Clin Pharmacol Ther; 2013 Dec; 94(6):670-7. PubMed ID: 23963252
    [TBL] [Abstract][Full Text] [Related]  

  • 23. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States.
    Ahmed I; Kaspar B; Sharma U
    Clin Ther; 2012 Feb; 34(2):400-19. PubMed ID: 22244050
    [TBL] [Abstract][Full Text] [Related]  

  • 24. Nutravigilance: principles and practices to enhance adverse event reporting in the dietary supplement and natural products industry.
    Schmitz SM; Lopez HL; MacKay D
    Int J Food Sci Nutr; 2014 Mar; 65(2):129-34. PubMed ID: 24112316
    [TBL] [Abstract][Full Text] [Related]  

  • 25. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
    Lee JY; Garnett CE; Gobburu JV; Bhattaram VA; Brar S; Earp JC; Jadhav PR; Krudys K; Lesko LJ; Li F; Liu J; Madabushi R; Marathe A; Mehrotra N; Tornoe C; Wang Y; Zhu H
    Clin Pharmacokinet; 2011 Oct; 50(10):627-35. PubMed ID: 21895036
    [TBL] [Abstract][Full Text] [Related]  

  • 26. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
    DiMasi JA
    Clin Ther; 2013 Jun; 35(6):808-18. PubMed ID: 23726388
    [TBL] [Abstract][Full Text] [Related]  

  • 27. Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys.
    Avery AJ; Anderson C; Bond CM; Fortnum H; Gifford A; Hannaford PC; Hazell L; Krska J; Lee AJ; McLernon DJ; Murphy E; Shakir S; Watson MC
    Health Technol Assess; 2011 May; 15(20):1-234, iii-iv. PubMed ID: 21545758
    [TBL] [Abstract][Full Text] [Related]  

  • 28. MedDRA® automated term groupings using OntoADR: evaluation with upper gastrointestinal bleedings.
    Souvignet J; Asfari H; Lardon J; Del Tedesco E; Declerck G; Bousquet C
    Expert Opin Drug Saf; 2016 Sep; 15(9):1153-61. PubMed ID: 27348725
    [TBL] [Abstract][Full Text] [Related]  

  • 29. Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed.
    Nicholson S; Peterson J; Yektashenas B
    Expert Opin Drug Saf; 2012 Mar; 11(2):299-314. PubMed ID: 22233294
    [TBL] [Abstract][Full Text] [Related]  

  • 30. Exploitation of semantic methods to cluster pharmacovigilance terms.
    Dupuch M; Dupuch L; Hamon T; Grabar N
    J Biomed Semantics; 2014; 5():18. PubMed ID: 24739596
    [TBL] [Abstract][Full Text] [Related]  

  • 31. Safety-related regulatory actions for biologicals approved in the United States and the European Union.
    Giezen TJ; Mantel-Teeuwisse AK; Straus SM; Schellekens H; Leufkens HG; Egberts AC
    JAMA; 2008 Oct; 300(16):1887-96. PubMed ID: 18940975
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Regulatory administrative databases in FDA's Center for Biologics Evaluation and Research: convergence toward a unified database.
    Smith JK
    AAPS J; 2013 Apr; 15(2):388-94. PubMed ID: 23269527
    [TBL] [Abstract][Full Text] [Related]  

  • 33. Preclinical assessment of abuse liability of biologics: In defense of current regulatory control policies.
    Gauvin DV; Zimmermann ZJ; Baird TJ
    Regul Toxicol Pharmacol; 2015 Oct; 73(1):43-54. PubMed ID: 26107292
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Empirical estimation of under-reporting in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).
    Alatawi YM; Hansen RA
    Expert Opin Drug Saf; 2017 Jul; 16(7):761-767. PubMed ID: 28447485
    [TBL] [Abstract][Full Text] [Related]  

  • 35. Examination of risk evaluation and mitigation strategies and drug safety in the US.
    Rodriguez-Monguio R; Spielberger K; Seoane-Vazquez E
    Res Social Adm Pharm; 2014; 10(1):232-8. PubMed ID: 23611865
    [TBL] [Abstract][Full Text] [Related]  

  • 36. MedDRA Labeling Groupings to Improve Safety Communication in Product Labels.
    Große-Michaelis I; Proestel S; Rao RM; Dillman BS; Bader-Weder S; Macdonald L; Gregory W
    Ther Innov Regul Sci; 2023 Jan; 57(1):1-6. PubMed ID: 35939205
    [TBL] [Abstract][Full Text] [Related]  

  • 37. Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule.
    Fed Regist; 1998 Jul; 63(147):40858-71. PubMed ID: 10181717
    [TBL] [Abstract][Full Text] [Related]  

  • 38. Recent drug approvals from the US FDA and EMEA: what the future holds.
    Pevarello P
    Future Med Chem; 2009 Apr; 1(1):35-48. PubMed ID: 21426069
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Automated support for pharmacovigilance: a proposed system.
    Bright RA; Nelson RC
    Pharmacoepidemiol Drug Saf; 2002 Mar; 11(2):121-5. PubMed ID: 11998536
    [TBL] [Abstract][Full Text] [Related]  

  • 40. Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2015 Jul; 80(127):37971-4. PubMed ID: 26155602
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 7.