Detalhe da pesquisa
1.
Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: A comparison with standard approved cancer drugs.
Br J Clin Pharmacol
; 88(5): 2169-2179, 2022 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-34779004
2.
Key Considerations in the Health Technology Assessment of Advanced Therapy Medicinal Products in Scotland, The Netherlands, and England.
Value Health
; 25(3): 390-399, 2022 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-35227451
3.
Estimation of manufacturing development costs of cell-based therapies: a feasibility study.
Cytotherapy
; 23(8): 730-739, 2021 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-33593688
4.
Signals from the Dutch national spontaneous reporting system: Characteristics and regulatory actions.
Pharmacoepidemiol Drug Saf
; 30(8): 1115-1122, 2021 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-33840136
5.
Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries.
Cytotherapy
; 22(10): 592-600, 2020 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-32563611
6.
What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings.
Cytotherapy
; 22(7): 388-397, 2020 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-32414635
7.
Organizational capacities of national pharmacovigilance centres in Africa: assessment of resource elements associated with successful and unsuccessful pharmacovigilance experiences.
Global Health
; 14(1): 109, 2018 11 16.
Artigo
em Inglês
| MEDLINE | ID: mdl-30445979
8.
The contribution of Ghanaian patients to the reporting of adverse drug reactions: a quantitative and qualitative study.
BMC Public Health
; 18(1): 1384, 2018 Dec 18.
Artigo
em Inglês
| MEDLINE | ID: mdl-30563498
9.
Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.
Br J Clin Pharmacol
; 82(1): 213-26, 2016 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-26992001
10.
Drug-Induced Reduction in Albuminuria Is Associated with Subsequent Renoprotection: A Meta-Analysis.
J Am Soc Nephrol
; 26(8): 2055-64, 2015 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-25421558
11.
An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe.
Eur J Clin Pharmacol
; 71(10): 1237-44, 2015 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-26204969
12.
Four scenarios for the future of medicines and social policy in 2030.
Drug Discov Today
; 27(8): 2252-2260, 2022 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-35364271
13.
The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs.
Int J Health Policy Manag
; 11(5): 642-650, 2022 May 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-33131224
14.
Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF-α Inhibitors.
Clin Pharmacol Ther
; 110(1): 123-131, 2021 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-33278830
15.
Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks.
Expert Opin Drug Saf
; 20(11): 1433-1442, 2021 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-34263667
16.
Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies.
Clin Transl Sci
; 14(4): 1566-1577, 2021 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-33786991
17.
Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries.
Regen Med
; 15(8): 2015-2028, 2020 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-33151792
18.
Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection.
Trends Pharmacol Sci
; 41(2): 67-71, 2020 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-31948797
19.
In-Hospital Production of Medicines: Preparing for Disruption.
Trends Biotechnol
; 38(10): 1045-1047, 2020 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-31679825
20.
Publication rates and reported results in a cohort of gene- and cell-based therapy trials.
Regen Med
; 15(1): 1215-1227, 2020 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-32103712