284 related articles for article (PubMed ID: 34689339)
1. Marketing Authorization Applications Made to the European Medicines Agency in 2018-2019: What was the Contribution of Real-World Evidence?
Flynn R; Plueschke K; Quinten C; Strassmann V; Duijnhoven RG; Gordillo-Marañon M; Rueckbeil M; Cohet C; Kurz X
Clin Pharmacol Ther; 2022 Jan; 111(1):90-97. PubMed ID: 34689339
[TBL] [Abstract][Full Text] [Related]
2. Contribution of Real-World Evidence in European Medicines Agency's Regulatory Decision Making.
Bakker E; Plueschke K; Jonker CJ; Kurz X; Starokozhko V; Mol PGM
Clin Pharmacol Ther; 2023 Jan; 113(1):135-151. PubMed ID: 36254408
[TBL] [Abstract][Full Text] [Related]
3. Use of Real-World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018-2019.
Eskola SM; Leufkens HGM; Bate A; De Bruin ML; Gardarsdottir H
Clin Pharmacol Ther; 2022 Jan; 111(1):310-320. PubMed ID: 34689334
[TBL] [Abstract][Full Text] [Related]
4. Understanding Use of Real-World Data and Real-World Evidence to Support Regulatory Decisions on Medical Product Effectiveness.
Mahendraratnam N; Mercon K; Gill M; Benzing L; McClellan MB
Clin Pharmacol Ther; 2022 Jan; 111(1):150-154. PubMed ID: 33891318
[TBL] [Abstract][Full Text] [Related]
5. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Salcher-Konrad M; Naci H; Davis C
Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
[TBL] [Abstract][Full Text] [Related]
6. Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe.
Davenport C; Gravel P; Wang Y; Williams SA; Wieland A; Mitlak B
Ther Innov Regul Sci; 2024 May; 58(3):505-518. PubMed ID: 38341388
[TBL] [Abstract][Full Text] [Related]
7. Licensing of Orphan Medicinal Products-Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021.
Naumann-Winter F; Wolter F; Hermes U; Malikova E; Lilienthal N; Meier T; Kalland ME; Magrelli A
Front Pharmacol; 2022; 13():920336. PubMed ID: 36034814
[No Abstract] [Full Text] [Related]
8. Translational hurdles with cannabis medicines.
Graham M; Lucas CJ; Schneider J; Martin JH; Hall W
Pharmacoepidemiol Drug Saf; 2020 Oct; 29(10):1325-1330. PubMed ID: 32281186
[TBL] [Abstract][Full Text] [Related]
9. Health Canada Usage of Real World Evidence (RWE) in Regulatory Decision Making compared with FDA/EMA usage based on publicly available information.
Lau C; Jamali F; Loebenberg R
J Pharm Pharm Sci; 2022; 25():227-236. PubMed ID: 35760071
[TBL] [Abstract][Full Text] [Related]
10. Comparison of two assessments of real-world data and real-world evidence for regulatory decision-making.
Yuan L; Rahman M; Concato J
Clin Transl Sci; 2024 Jan; 17(1):e13702. PubMed ID: 38093484
[TBL] [Abstract][Full Text] [Related]
11. Use of Real-World Evidence to Support FDA Approval of Oncology Drugs.
Feinberg BA; Gajra A; Zettler ME; Phillips TD; Phillips EG; Kish JK
Value Health; 2020 Oct; 23(10):1358-1365. PubMed ID: 33032780
[TBL] [Abstract][Full Text] [Related]
12. Real-World Data in the Postapproval Setting as Applied by the EMA and the US FDA.
Mofid S; Bolislis WR; Kühler TC
Clin Ther; 2022 Feb; 44(2):306-322. PubMed ID: 35074209
[TBL] [Abstract][Full Text] [Related]
13. Measuring the Effectiveness of Real-World Evidence to Ensure Appropriate Impact.
Brown JP; Douglas IJ; Hanif S; Thwaites RMA; Bate A
Value Health; 2021 Sep; 24(9):1241-1244. PubMed ID: 34452702
[TBL] [Abstract][Full Text] [Related]
14. The role of Real-World Data and evidence in oncology medicines approved in EU in 2018-2019.
Eskola SM; Leufkens HGM; Bate A; De Bruin ML; Gardarsdottir H
J Cancer Policy; 2023 Jun; 36():100424. PubMed ID: 37116794
[TBL] [Abstract][Full Text] [Related]
15. A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China.
Storm NE; Chang W; Lin TC; Lange JL; Bradbury B; Critchlow CW; Galson SK
Ther Innov Regul Sci; 2022 Jan; 56(1):137-144. PubMed ID: 34633649
[TBL] [Abstract][Full Text] [Related]
16. Expert survey on real-world data utilization and real-world evidence generation for regulatory decision-making in drug lifecycle in Korea.
Lee H; Ahn HS; Kwon S; Kang HY; Han E
Clin Transl Sci; 2024 Apr; 17(4):e13801. PubMed ID: 38629484
[TBL] [Abstract][Full Text] [Related]
17. Use of Real-world Data for New Drug Applications and Line Extensions.
Bolislis WR; Fay M; Kühler TC
Clin Ther; 2020 May; 42(5):926-938. PubMed ID: 32340916
[TBL] [Abstract][Full Text] [Related]
18. The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.
Purpura CA; Garry EM; Honig N; Case A; Rassen JA
Clin Pharmacol Ther; 2022 Jan; 111(1):135-144. PubMed ID: 34726771
[TBL] [Abstract][Full Text] [Related]
19. Pharmacogenetic-Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency Between 2014 and 2017.
Maliepaard M; Toiviainen T; De Bruin ML; Meulendijks D
Clin Pharmacol Ther; 2020 Aug; 108(2):338-349. PubMed ID: 32236952
[TBL] [Abstract][Full Text] [Related]
20. Selection of Endpoints in Clinical Trials: Trends in European Marketing Authorization Practice in Oncological Indications.
Kordecka A; Walkiewicz-Żarek E; Łapa J; Sadowska E; Kordecki M
Value Health; 2019 Aug; 22(8):884-890. PubMed ID: 31426929
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]