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1.
Patient-reported, observer-reported and performance outcomes in qualification procedures at the European Medicines Agency 2013-2018.
Br J Clin Pharmacol
; 90(1): 299-312, 2024 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-37697483
2.
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
Br J Clin Pharmacol
; 86(6): 1034-1051, 2020 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-32162368
3.
The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.
Br J Clin Pharmacol
; 84(5): 1013-1019, 2018 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-29370449
4.
Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.
Value Health
; 20(1): 2-14, 2017 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-28212963
5.
How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.
Br J Clin Pharmacol
; 82(4): 965-73, 2016 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-27245362
6.
Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.
Value Health
; 18(6): 741-52, 2015 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-26409600
7.
Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.
Alzheimers Dement
; 10(4): 421-429.e3, 2014 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-24985687
8.
Biomarker-Driven Developments in the Context of the New Regulatory Framework for Companion Diagnostics in the European Union.
Clin Pharmacol Ther
; 114(2): 316-324, 2023 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-37132507
9.
Role of modeling and simulation in pediatric investigation plans.
Paediatr Anaesth
; 21(3): 214-21, 2011 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-21244569
10.
The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study.
Front Med (Lausanne)
; 8: 811855, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-35127766
11.
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth.
Clin Pharmacol Ther
; 109(5): 1212-1218, 2021 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-33063841
12.
Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.
Eur J Clin Pharmacol
; 66(1): 39-48, 2010 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-19936724
13.
Clinical Trials for COVID-19: Can we Better Use the Short Window of Opportunity?
Clin Pharmacol Ther
; 108(4): 730-733, 2020 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-32407539
14.
Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.
Clin Pharmacol Ther
; 107(4): 773-779, 2020 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-31574163
15.
The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson's Disease.
J Parkinsons Dis
; 9(3): 553-563, 2019.
Artículo
en Inglés
| MEDLINE | ID: mdl-31306141
16.
Marketing authorisation of orphan medicines in Europe from 2000 to 2013.
Drug Discov Today
; 23(2): 424-433, 2018 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-29074441
17.
Therapeutic Innovations in Neuroscience: What's New on the Horizon?
Clin Pharmacol Ther
; 111(4): 715-717, 2022 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-35313013
18.
Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.
Front Med (Lausanne)
; 4: 53, 2017.
Artículo
en Inglés
| MEDLINE | ID: mdl-28560211
19.
Analysis of renal cell transformation following exposure to trichloroethene in vivo and its metabolite S-(dichlorovinyl)-L-cysteine in vitro.
Toxicology
; 224(1-2): 108-18, 2006 Jul 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-16730402
20.
The European Medicines Agency experience with biomarker qualification.
Methods Mol Biol
; 1243: 255-72, 2015.
Artículo
en Inglés
| MEDLINE | ID: mdl-25384751