Detalles de la búsqueda
1.
Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group.
Int J Technol Assess Health Care
; 39(1): e40, 2023 Jun 16.
Artículo
en Inglés
| MEDLINE | ID: mdl-37325997
2.
Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements.
Int J Technol Assess Health Care
; 37(1): e83, 2021 Aug 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-34424152
3.
Improving Transparency to Build Trust in Real-World Secondary Data Studies for Hypothesis Testing-Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative.
Value Health
; 23(9): 1128-1136, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32940229
4.
Improving transparency to build trust in real-world secondary data studies for hypothesis testing-Why, what, and how: recommendations and a road map from the real-world evidence transparency initiative.
Pharmacoepidemiol Drug Saf
; 29(11): 1504-1513, 2020 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-32924243
5.
The evolution of clinical trials: Can we address the challenges of the future?
Clin Trials
; 15(1_suppl): 27-32, 2018 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-29452522
6.
Emerging technologies for food and drug safety.
Regul Toxicol Pharmacol
; 98: 115-128, 2018 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-30048704
7.
Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making.
Value Health
; 20(8): 1003-1008, 2017 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-28964430
8.
Definition of variables required for comprehensive description of drug dosage and clinical pharmacokinetics.
Eur J Clin Pharmacol
; 73(5): 633-641, 2017 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-28197684
9.
Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.
Pharmacoepidemiol Drug Saf
; 26(9): 1033-1039, 2017 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-28913966
10.
Facilitating Antibacterial Drug Development in a Time of Great Need.
Clin Infect Dis
; 63 Suppl 2: S27-8, 2016 Aug 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-27481949
11.
Regulatory bioinformatics for food and drug safety.
Regul Toxicol Pharmacol
; 80: 342-7, 2016 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-27208439
12.
Drug Regulation and Pricing--Can Regulators Influence Affordability?
N Engl J Med
; 374(19): 1807-9, 2016 May 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-27168431
13.
Improving the contribution of regulatory assessment reports to health technology assessments--a collaboration between the European Medicines Agency and the European network for Health Technology Assessment.
Value Health
; 17(5): 634-41, 2014 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-25128058
14.
Modelling the risk-benefit impact of H1N1 influenza vaccines.
Eur J Public Health
; 23(4): 674-8, 2013 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-23402804
15.
Orphan drugs' clinical uncertainty and prices: Addressing allocative and technical inefficiencies in orphan drug reimbursement.
Front Pharmacol
; 14: 1074512, 2023.
Artículo
en Inglés
| MEDLINE | ID: mdl-36778019
16.
Patients, payers and developers of Orphan Medicinal Products: lessons learned from 10 years' multi-stakeholder dialogue on improving access in Europe via MoCA.
Orphanet J Rare Dis
; 18(1): 144, 2023 06 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-37308991
17.
Transparency and the European Medicines Agency--sharing of clinical trial data.
N Engl J Med
; 371(26): 2452-5, 2014 Dec 25.
Artículo
en Inglés
| MEDLINE | ID: mdl-25539105
18.
Precision Reimbursement for Precision Medicine: Using Real-World Evidence to Evolve From Trial-and-Project to Track-and-Pay to Learn-and-Predict.
Clin Pharmacol Ther
; 111(1): 52-62, 2022 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34716918
19.
A Useful and Sustainable Role for N-of-1 Trials in the Healthcare Ecosystem.
Clin Pharmacol Ther
; 112(2): 224-232, 2022 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-34551122
20.
Access to patient-level trial data--a boon to drug developers.
N Engl J Med
; 369(17): 1577-9, 2013 Oct 24.
Artículo
en Inglés
| MEDLINE | ID: mdl-24144395