131 related articles for article (PubMed ID: 28570569)
1. Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.
Chang LC; Mahmood R; Qureshi S; Breder CD
PLoS One; 2017; 12(6):e0178104. PubMed ID: 28570569
[TBL] [Abstract][Full Text] [Related]
2. Standardised MedDRA queries: their role in signal detection.
Mozzicato P
Drug Saf; 2007; 30(7):617-9. PubMed ID: 17604415
[TBL] [Abstract][Full Text] [Related]
3. Semantic distance-based creation of clusters of pharmacovigilance terms and their evaluation.
Dupuch M; Grabar N
J Biomed Inform; 2015 Apr; 54():174-85. PubMed ID: 25659451
[TBL] [Abstract][Full Text] [Related]
4. A Critical Evaluation of Safety Signal Analysis Using Algorithmic Standardised MedDRA Queries.
Tieu C; Breder CD
Drug Saf; 2018 Dec; 41(12):1375-1385. PubMed ID: 30112728
[TBL] [Abstract][Full Text] [Related]
5. Performance of the standardised MedDRA® queries for case retrieval in the French spontaneous reporting database.
Géniaux H; Assaf D; Miremont-Salamé G; Raspaud B; Gouverneur A; Robinson P; Pariente A; Salvo F
Drug Saf; 2014 Jul; 37(7):537-42. PubMed ID: 24942754
[TBL] [Abstract][Full Text] [Related]
6. Influence of the MedDRA hierarchy on pharmacovigilance data mining results.
Pearson RK; Hauben M; Goldsmith DI; Gould AL; Madigan D; O'Hara DJ; Reisinger SJ; Hochberg AM
Int J Med Inform; 2009 Dec; 78(12):e97-e103. PubMed ID: 19230751
[TBL] [Abstract][Full Text] [Related]
7. Participation of women and sex analyses in late-phase clinical trials of new molecular entity drugs and biologics approved by the FDA in 2007-2009.
Poon R; Khanijow K; Umarjee S; Fadiran E; Yu M; Zhang L; Parekh A
J Womens Health (Larchmt); 2013 Jul; 22(7):604-16. PubMed ID: 23768021
[TBL] [Abstract][Full Text] [Related]
8. Use of Real-World Evidence in Neuroscience-Related New Drug and Biologics License Applications for Novel Therapeutics.
Bloomfield-Clagett B; Rahman M; Smith K; Concato J
Clin Pharmacol Ther; 2023 Nov; 114(5):1002-1005. PubMed ID: 37548904
[TBL] [Abstract][Full Text] [Related]
9. A Comprehensive Methodology to Systematically Identify Drug Hypersensitivity and Anaphylactic Reactions in Clinical Trial Databases.
Xavier H; Hara I; Ottesen LH; Verheijen RB; Ghiorghiu D; Morgan C
Pharmaceut Med; 2020 Oct; 34(5):335-345. PubMed ID: 32975782
[TBL] [Abstract][Full Text] [Related]
10. Grouping pharmacovigilance terms with semantic distance.
Dupuch M; Lerch M; Jamet A; Jaulent MC; Fescharek R; Grabar N
Stud Health Technol Inform; 2011; 169():794-8. PubMed ID: 21893856
[TBL] [Abstract][Full Text] [Related]
11. Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA).
Brown EG
Drug Saf; 2003; 26(3):145-58. PubMed ID: 12580645
[TBL] [Abstract][Full Text] [Related]
12. Assessment of the approved Risk Evaluation and Mitigation Strategy programs for New Drug Applications and Biologics Licensing Applications.
Johnson NA; Priefer R
Regul Toxicol Pharmacol; 2019 Feb; 101():53-56. PubMed ID: 30473489
[TBL] [Abstract][Full Text] [Related]
13. A Method for Retrieval of Adverse Event Terms in Clinical Trial Databases Using Standardised MedDRA Queries.
Breder CD
Pharmaceut Med; 2016 Apr; 30(2):103-108. PubMed ID: 27274655
[TBL] [Abstract][Full Text] [Related]
14. Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration.
Bai JPF; Earp JC; Florian J; Madabushi R; Strauss DG; Wang Y; Zhu H
CPT Pharmacometrics Syst Pharmacol; 2021 Dec; 10(12):1479-1484. PubMed ID: 34734497
[TBL] [Abstract][Full Text] [Related]
15. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker.
Berlin C; Blanch C; Lewis DJ; Maladorno DD; Michel C; Petrin M; Sarp S; Close P
Pharmacoepidemiol Drug Saf; 2012 Jun; 21(6):622-30. PubMed ID: 21994119
[TBL] [Abstract][Full Text] [Related]
16. Evaluation of automated term groupings for detecting anaphylactic shock signals for drugs.
Souvignet J; Declerck G; Trombert B; Rodrigues JM; Jaulent MC; Bousquet C
AMIA Annu Symp Proc; 2012; 2012():882-90. PubMed ID: 23304363
[TBL] [Abstract][Full Text] [Related]
17. Evaluation of an ontological resource for pharmacovigilance.
Jaulent MC; Alecu I
Stud Health Technol Inform; 2009; 150():522-6. PubMed ID: 19745366
[TBL] [Abstract][Full Text] [Related]
18. Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA From 2010 to 2012.
Eshera N; Itana H; Zhang L; Soon G; Fadiran EO
Am J Ther; 2015; 22(6):435-55. PubMed ID: 25621972
[TBL] [Abstract][Full Text] [Related]
19. EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology.
Dixon WG; Carmona L; Finckh A; Hetland ML; Kvien TK; Landewe R; Listing J; Nicola PJ; Tarp U; Zink A; Askling J
Ann Rheum Dis; 2010 Sep; 69(9):1596-602. PubMed ID: 20525843
[TBL] [Abstract][Full Text] [Related]
20. Missing data issues at the FDA Center for Biologics Evaluation and Research.
Scott JA; Hsu H
J Biopharm Stat; 2011 Mar; 21(2):196-201. PubMed ID: 21390996
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]