Cargando…

Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers

OBJECTIVES: Stratified medicine is often heralded as the future of clinical practice. Key part of stratified medicine is the use of predictive biomarkers, which identify patient subgroups most likely to benefit (or least likely to experience harm) from an intervention. We investigated how many and w...

Descripción completa

Detalles Bibliográficos
Autores principales:	Malottki, Kinga, Biswas, Mousumi, Deeks, Jonathan J, Riley, Richard D, Craddock, Charles, Johnson, Philip, Billingham, Lucinda
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2014
Materias:	Pharmacology and Therapeutics
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3913033/ https://www.ncbi.nlm.nih.gov/pubmed/24468721 http://dx.doi.org/10.1136/bmjopen-2013-004188

Ejemplares similares

Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications
por: Malottki, Kinga, et al.
Publicado: (2011)

Reviewing the evidence supporting predictive biomarkers in European medicines agency indications and contraindications using visual plots
por: Malottki, Kinga, et al.
Publicado: (2015)

Problems of variable biomarker evaluation in stratified medicine research—A case study of ERCC1 in non-small-cell lung cancer
por: Malottki, Kinga, et al.
Publicado: (2016)

Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017
por: Brown, Jeremy Philip, et al.
Publicado: (2019)

Licensing of Orphan Medicinal Products—Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021
por: Naumann-Winter, Frauke, et al.
Publicado: (2022)

Stratified Medicine and Reimbursement Issues
por: Fugel, Hans-Joerg, et al.
Publicado: (2012)

Trials in rare diseases: the need to think differently
por: Billingham, Lucinda, et al.
Publicado: (2011)

Real-world evidence (RWE): A challenge for regulatory agencies discussion of the RWE conference with the network of the european medicine agencies, patients, and experts
por: Maison, Patrick, et al.
Publicado: (2022)

Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency
por: Orellana García, Laura Patricia, et al.
Publicado: (2021)

Availability and Affordability of Drugs With a Conditional Approval by the European Medicines Agency; Comparison of Korea With Other Countries and the Implications
por: Kwon, Hye-Young, et al.
Publicado: (2018)

Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines
por: Jordan, Sue, et al.
Publicado: (2018)

Economic Evaluation in Stratified Medicine: Methodological Issues and Challenges
por: Fugel, Hans-Joerg, et al.
Publicado: (2016)

Characteristics of drug safety alerts issued by the Spanish Medicines Agency
por: Montané, Eva, et al.
Publicado: (2023)

Cross-sectional study on medicinal products without commercial interest (MPWCI) in the Spanish market
por: Esteve Sala, Emili, et al.
Publicado: (2019)

Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment
por: Malinowski, Krzysztof Piotr, et al.
Publicado: (2018)

Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System
por: Gnädinger, Markus, et al.
Publicado: (2015)

Sustained Antidiabetic Effects of a Berberine-Containing Chinese Herbal Medicine Through Regulation of Hepatic Gene Expression
por: Zhao, Hai-Lu, et al.
Publicado: (2012)

PIM-Check: development of an international prescription-screening checklist designed by a Delphi method for internal medicine patients
por: Desnoyer, Aude, et al.
Publicado: (2017)

Applying quality improvement methods to address gaps in medicines reconciliation at transfers of care from an acute UK hospital
por: Marvin, Vanessa, et al.
Publicado: (2016)

Biomarker Qualification at the European Medicines Agency: A Look Under the Hood
por: Berman, Steven, et al.
Publicado: (2022)

The association between patients’ beliefs about medicines and adherence to drug treatment after stroke: a cross-sectional questionnaire survey
por: Sjölander, Maria, et al.
Publicado: (2013)

Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs
por: Giannuzzi, Viviana, et al.
Publicado: (2017)

Emergency supply of prescription-only medicines to patients by community pharmacists: a mixed methods evaluation incorporating patient, pharmacist and GP perspectives
por: Morecroft, Charles W, et al.
Publicado: (2015)

Discrepancies in drug histories at admission to gastrointestinal surgery, internal medicine and geriatric hospital wards in Central Norway: a cross-sectional study
por: Sund, Janne Kutschera, et al.
Publicado: (2017)

Prevalence of hospitalisation caused by adverse drug reactions at an internal medicine ward of a single centre in Japan: a cross-sectional study
por: Komagamine, Junpei, et al.
Publicado: (2019)

Evaluation of the Performance of the Turkish Regulatory Agency: Recommendations for Improved Patients’ Access to Medicines
por: Koyuncu, Oguzhan, et al.
Publicado: (2020)

Prevalence, clinical relevance and predictive factors of medication discrepancies revealed by medication reconciliation at hospital admission: prospective study in a Swiss internal medicine ward
por: Giannini, Olivier, et al.
Publicado: (2019)

Psychopharmacology at the era of EMEA (European Medicines Agency)
por: Pestana, Luis Camara, et al.
Publicado: (2010)

A bacteriophage journey at the European Medicines Agency
por: Debarbieux, Laurent, et al.
Publicado: (2015)

What is associated with increased side effects and lower perceived efficacy following switching to a generic medicine? A New Zealand cross-sectional patient survey
por: MacKrill, Kate, et al.
Publicado: (2018)

Impact of National Drug Pricing Policy 2018 on access to medicines in Lahore division, Pakistan: a pre-post survey study using WHO/HAI methodology
por: Saeed, Amna, et al.
Publicado: (2020)

What were the impacts of the Committee on Safety of Medicines warning and publication of the NICE guidelines on trends in child and adolescent antidepressant prescribing in primary care? A population based study
por: Tiffin, Paul A, et al.
Publicado: (2019)

A question–answer pair (QAP) database integrated with websites to answer complex questions submitted to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS): a descriptive study
por: Schjøtt, Jan, et al.
Publicado: (2012)

Price and affordability of key essential medicines for children in Sri Lanka, a lower-middle-income country: comparison of two national cross-sectional surveys done 8 years apart
por: Sri Ranganathan, Shalini, et al.
Publicado: (2023)

The European Medicines Agency's approval of new medicines for type 2 diabetes
por: Blind, Eberhard, et al.
Publicado: (2018)

Safer medicines To reduce falls and refractures for OsteoPorosis (#STOP): a study protocol for a randomised controlled trial of medical specialist-initiated pharmacist-led medication management reviews in primary care
por: Moles, Rebekah Jane, et al.
Publicado: (2023)

Impact of body weight, low energy diet and gastric bypass on drug bioavailability, cardiovascular risk factors and metabolic biomarkers: protocol for an open, non-randomised, three-armed single centre study (COCKTAIL)
por: Hjelmesæth, Jøran, et al.
Publicado: (2018)

Prevalence of potentially inappropriate prescribing in a subpopulation of older European clinical trial participants: a cross-sectional study
por: O Riordan, David, et al.
Publicado: (2018)

The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach
por: Nicotera, Giuseppe, et al.
Publicado: (2019)

Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020
por: Bakker, Elisabeth, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_b1aarh8ir30hiltk3qvnfelokt