Cargando…

Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications

Detalles Bibliográficos
Autores principales:	Malottki, Kinga, Biswas, Mousumi, Deeks, Jon, Riley, Richard, Craddock, Charles, Billingham, Lucinda
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2011
Materias:	Oral Presentation
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3287729/ http://dx.doi.org/10.1186/1745-6215-12-S1-A16

Ejemplares similares

Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers
por: Malottki, Kinga, et al.
Publicado: (2014)

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)

Extension of the European Medicines Agency (EMA) approval of trifluridine/tipiracil for gastric cancer
por: Alsina, Maria, et al.
Publicado: (2019)

Focus on Clozapine Withdrawal- and Misuse-Related Cases as Reported to the European Medicines Agency (EMA) Pharmacovigilance Database
por: Chiappini, Stefania, et al.
Publicado: (2020)

Recommendations by the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) Working Group on preparedness of clinical trials about paediatric medicines process
por: Siapkara, Angeliki, et al.
Publicado: (2021)

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

Is there such a thing as a 'lope' dope? Analysis of loperamide-related European Medicines Agency (EMA) pharmacovigilance database reports
por: Schifano, Fabrizio, et al.
Publicado: (2018)

Is European Medicines Agency (EMA) sepsis criteria accurate for neonatal sepsis diagnosis or do we need new criteria?
por: Tuzun, Funda, et al.
Publicado: (2019)

Excellence in Family Paediatricians: the FIMP-MCRN (Medicines for Children Research Network) becomes a member of ENPR-EMA (European Network of Paediatric Research at the European Medicines Agency)
por: Napoleone, Ettore
Publicado: (2011)

Dose transition pathways: a design, analysis and operational tool for dose-finding trials using model-based designs
por: Yap, Christina, et al.
Publicado: (2015)

Combining multiple predictive markers in stratified medicine
por: Emsley, Richard, et al.
Publicado: (2015)

Non-vitamin-K oral anticoagulants and laboratory testing: now and in the future: Views from a workshop at the European Medicines Agency (EMA)
por: Salmonson, Tomas, et al.
Publicado: (2017)

Considerations for the chemistry, manufacturing and Controls (CMC) - quality package for COVID-19 vaccines- interim lessons learnt by the European medicines Agency (EMA)
por: Shivji, Ragini, et al.
Publicado: (2022)

Implementation of adaptive dose-finding designs in two early phase haematological trials: clinical, operational, and methodological challenges
por: Yap, Christina, et al.
Publicado: (2013)

Using meta-analysis of Phase II trials to predict Phase III trial results
por: Burke, Danielle, et al.
Publicado: (2013)

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

EMA issues recommendations on impurities in medicines
Publicado: (2020)

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

Crossing survival curves: alternatives to the log-rank test
por: Bouliotis, George, et al.
Publicado: (2011)

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)

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

Who do treatments work for and why? Understanding treatment-effect mechanisms in stratified medicine
por: Emsley, Richard, et al.
Publicado: (2013)

Screened selection design for randomised phase II oncology trials: an example in chronic lymphocytic leukaemia
por: Yap, Christina, et al.
Publicado: (2011)

Evaluation of methods to adjust for treatment switching in clinical trials
por: Fox, Richard, et al.
Publicado: (2011)

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)

Adaptive enrichment in biomarker-stratified clinical trial design
por: Parashar, Deepak, et al.
Publicado: (2013)

Review: UK medicines likely to be affected by the proposed European Medicines Agency’s guidelines on phthalates
por: Jamieson, Lisa, et al.
Publicado: (2015)

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications
por: Lenić, Ines, et al.
Publicado: (2019)

The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency
por: Jandhyala, Ravi
Publicado: (2022)

Type I error control in biomarker-stratified clinical trials
por: Parashar, Deepak, et al.
Publicado: (2015)

Using a Bayesian approach with reverse philosophy to design clinical trials in rare diseases
por: Billingham, Lucinda, et al.
Publicado: (2013)

Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies
por: Bloem, Lourens T., et al.
Publicado: (2021)

Overview of the European Medicines Agency's Development of Product‐Specific Bioequivalence Guidelines
por: Sullivan, Jane O', et al.
Publicado: (2018)

Persian Medicine in the World of Research; Review of Articles on Iranian Traditional Medicine
por: Moeini, Reihaneh, et al.
Publicado: (2016)

Improving Risk Assessment in the European Food Safety Authority: Lessons From the European Medicines Agency
por: Chatzopoulou, Sevasti, et al.
Publicado: (2020)

European Medicines Agency Conflicts With the European Food Safety Authority (EFSA) on Bisphenol A Regulation
por: Zoeller, R Thomas, et al.
Publicado: (2023)

Access to regulatory data from the European Medicines Agency: the times they are a-changing
por: Wieseler, Beate, et al.
Publicado: (2012)

Cannot write session to /tmp/vufind_sessions/sess_3r5v50oqu98do9o0mpe0fp4cjh