A5039524438- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical Economics and Policy
- Pharmacovigilance and Adverse Drug Reactions
- Biomedical Ethics and Regulation
- Statistical Methods in Clinical Trials
- Acute Lymphoblastic Leukemia research
- Computational Drug Discovery Methods
- Drug-Induced Adverse Reactions
- Biosimilars and Bioanalytical Methods
- Cancer Genomics and Diagnostics
- Global Public Health Policies and Epidemiology
- Glaucoma and retinal disorders
- Corneal Surgery and Treatments
- Pneumocystis jirovecii pneumonia detection and treatment
- Economic and Financial Impacts of Cancer
- Science, Research, and Medicine
- Global Health Care Issues
- Health and Medical Research Impacts
- Biotechnology and Related Fields
- Pancreatic and Hepatic Oncology Research
- Lung Cancer Treatments and Mutations
- Inflammatory Bowel Disease
- Innovation Policy and R&D
- Biomedical and Engineering Education
- Chronic Lymphocytic Leukemia Research
CEA Paris-Saclay
2023
Chimie Moléculaire, Macromoléculaire, Matériaux
2023
Commissariat à l'Énergie Atomique et aux Énergies Alternatives
2023
National Institute for Health and Care Excellence
2014-2022
Office Of Health Economics
2016-2019
European Medicines Agency
2008-2010
Environment Agency
2010
Inserm
1996-1997
Sorbonne Université
1996
Hôpital Saint-Antoine
1996
The primary objective of this study was to compare the availability and access orphan medicinal products (OMPs) in devolved nations United Kingdom (UK), France, Germany, Italy Spain. Availability is defined as possibility prescribe OMPs. Access refers their full or partial reimbursement by public health service.Data were collated on: marketing authorisations, Health Technology Assessment (HTA) decisions, commissioning, respective dates these events for all OMPs centrally authorised....
Masking is a statistical issue by which signals are hidden the presence of other medicines in database. In absence algorithm, impact masking effect has not been fully investigated.Our study aimed at assessing extent and on two large spontaneous reporting databases.Cross sectional using set terms importance for public health databases.The analyses were performed EudraVigilance (EV) Pfizer database (PfDB).Using ratio, we have identified removed products inducing highest effect.Studying total...
Sophie Cooper, Jacoline Bouvy and colleagues discuss the challenges that histology independent cancer drugs will pose for NICE NHS
ABSTRACT Background Masking is a statistical issue by which true signals of disproportionate reporting are hidden the presence other products in database. currently not perfectly understood. There no algorithm to identify potential masking drugs remove them for subsequent analyses disproportionality. Objective The primary objective our study develop mathematical framework assessing extent and impact effect measures Method We have developed ratio that quantifies given product. conducted...
The lower bound of the 95% confidence interval measures disproportionality (Lower95CI) is widely used in signal detection. Masking a statistical issue by which true signals disproportionate reporting are hidden presence other medicines. primary objective our study to develop and validate mathematical framework for assessing masking effect Lower95CI.We have developed new algorithm based on ratio (MR) disproportionality. A MR Lower95CI (MRCI) proposed. simulation this was also conducted.We...
Pharmacological blockade of fibroblastic proliferation after glaucoma filtration surgery by using antimitotic agents in different formulations (liposomes, nanospheres) is great clinical interest. However, only limited comparative data are available on the effect encapsulated drugs intraocular pressure (IOP) filtering surgery. Therefore we have studied IOP liposomes, nanospheres and a solution mitoxantrone (MTO), well-known antimitotic, rabbits before sclerectomy. MTO form, as well liposome...
INTRODUCTION: Under the Orphan Regulation, European Medicines Agency (EMA) intended to incentivize research and development of new treatments for rare life-threatening conditions. Marketing authorisation orphan medicinal products (OMPs) by EMA is only first step, as medicines are made available patients when reimbursement or Health Technology Assessment (HTA) decisions implemented national health systems. We analyzed availability access OMPs in United Kingdom (UK), France, Germany, Italy...
Wound healing is the main cause of failure filtering surgery in glaucoma. We developed a liposomal delivery system mitoxantrone (MITX), an anthracyclin derivative, to allow single adjuvant administration and lessen ocular side-effects drug. In order evaluate antiproliferative activity MITX, ex vivo model consisting culture subconjunctival tissue expiants from rabbits pretreated with injections free or MITX was used. found that both forms decreased growth rate as well expiant proliferation...