196 related articles for article (PubMed ID: 35590360)
1. Data-sharing and re-analysis for main studies assessed by the European Medicines Agency-a cross-sectional study on European Public Assessment Reports.
Siebert M; Gaba J; Renault A; Laviolle B; Locher C; Moher D; Naudet F
BMC Med; 2022 May; 20(1):177. PubMed ID: 35590360
[TBL] [Abstract][Full Text] [Related]
2. The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.
Schuster Bruce C; Brhlikova P; Heath J; McGettigan P
PLoS Med; 2019 Sep; 16(9):e1002873. PubMed ID: 31504034
[TBL] [Abstract][Full Text] [Related]
3. The evidence base for psychotropic drugs approved by the European Medicines Agency: a meta-assessment of all European Public Assessment Reports.
Erhel F; Scanff A; Naudet F
Epidemiol Psychiatr Sci; 2020 Apr; 29():e120. PubMed ID: 32336312
[TBL] [Abstract][Full Text] [Related]
4. Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation.
Hopkins AM; Modi ND; Rockhold FW; Hoffmann T; Menz BD; Veroniki AA; McKinnon RA; Rowland A; Swain SM; Ross JS; Sorich MJ
J Clin Epidemiol; 2024 Mar; 167():111263. PubMed ID: 38219810
[TBL] [Abstract][Full Text] [Related]
5. Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
Kirsch-Stefan N; Guillen E; Ekman N; Barry S; Knippel V; Killalea S; Weise M; Wolff-Holz E
BioDrugs; 2023 Nov; 37(6):855-871. PubMed ID: 37831324
[TBL] [Abstract][Full Text] [Related]
6. Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration.
Modi ND; Abuhelwa AY; McKinnon RA; Boddy AV; Haseloff M; Wiese MD; Hoffmann TC; Perakslis ED; Rowland A; Sorich MJ; Hopkins AM
JAMA Oncol; 2022 Sep; 8(9):1310-1316. PubMed ID: 35900732
[TBL] [Abstract][Full Text] [Related]
7. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices.
Miller J; Ross JS; Wilenzick M; Mello MM
BMJ; 2019 Jul; 366():l4217. PubMed ID: 31292127
[TBL] [Abstract][Full Text] [Related]
8. Clinical trials for authorized biosimilars in the European Union: a systematic review.
Mielke J; Jilma B; Koenig F; Jones B
Br J Clin Pharmacol; 2016 Dec; 82(6):1444-1457. PubMed ID: 27580073
[TBL] [Abstract][Full Text] [Related]
9. Information for adequate prescribing to older patients : an evaluation of the product information of 53 recently approved medicines.
Beers E; Egberts TC; Leufkens HG; Jansen PA
Drugs Aging; 2013 Apr; 30(4):255-62. PubMed ID: 23420118
[TBL] [Abstract][Full Text] [Related]
10. 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]
11. Clinical study reports published by the European Medicines Agency 2016-2018: a cross-sectional analysis.
Byrne D; Prendergast C; Fahey T; Moriarty F
BMJ Open; 2023 May; 13(5):e068981. PubMed ID: 37188475
[TBL] [Abstract][Full Text] [Related]
12. Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017-2022.
Ciani O; Meregaglia M; Battaglia MA; Brichetto G; Conte A; Gasperini C; Sansone V
Neurol Sci; 2023 Aug; 44(8):2933-2937. PubMed ID: 37145229
[TBL] [Abstract][Full Text] [Related]
13. Clinical evidence supporting the marketing authorization of biosimilars in Europe.
Allocati E; Bertele' V; Gerardi C; Garattini S; Banzi R
Eur J Clin Pharmacol; 2020 Apr; 76(4):557-566. PubMed ID: 31897530
[TBL] [Abstract][Full Text] [Related]
14. Mobility endpoints in marketing authorisation of drugs: what gets the European medicines agency moving?
Jaeger SU; Wohlrab M; Schoene D; Tremmel R; Chambers M; Leocani L; Corriol-Rohou S; Klenk J; Sharrack B; Garcia-Aymerich J; Rochester L; Maetzler W; Puhan M; Schwab M; Becker C
Age Ageing; 2022 Jan; 51(1):. PubMed ID: 35077553
[TBL] [Abstract][Full Text] [Related]
15. Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study.
Alsamil AM; Giezen TJ; Egberts TC; Leufkens HG; Gardarsdottir H
Biologicals; 2021 Jan; 69():30-37. PubMed ID: 33454195
[TBL] [Abstract][Full Text] [Related]
16. The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022.
Meregaglia M; Malandrini F; Angelini S; Ciani O
Appl Health Econ Health Policy; 2023 Nov; 21(6):925-935. PubMed ID: 37659000
[TBL] [Abstract][Full Text] [Related]
17. Medication Adherence Measurement Methods in Registration Trials Supporting the Approval of New Medicines: A Cross-Sectional Analysis of Centralized Procedures in the European Union 2010-2020.
Mantila KM; Pasmooij AMG; Hallgreen CE; Mol PGM; van Boven JFM
Clin Pharmacol Ther; 2022 Nov; 112(5):1051-1060. PubMed ID: 35816103
[TBL] [Abstract][Full Text] [Related]
18. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Ceci A; Felisi M; Catapano M; Baiardi P; Cipollina L; Ravera S; Bagnulo S; Reggio S; Rondini G
Eur J Clin Pharmacol; 2002 Nov; 58(8):495-500. PubMed ID: 12451425
[TBL] [Abstract][Full Text] [Related]
19. Sex as a variable in medicines assessment reports for licensing in the European Union. Can gender bias be excluded?
Laguna-Goya N; de Andres-Trelles F
Eur J Clin Pharmacol; 2014 May; 70(5):519-25. PubMed ID: 24515611
[TBL] [Abstract][Full Text] [Related]
20. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.
Hwang TJ; Tomasi PA; Bourgeois FT
PLoS Med; 2018 Mar; 15(3):e1002520. PubMed ID: 29494592
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
