Cargando…

Pharmacogenetic‐Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency Between 2014 and 2017

This study aimed to determine to which extent data on potential pharmacogenetic‐pharmacokinetic (PG‐PK) interactions are provided to, and assessed by, the European Medicines Agency (EMA) in novel drug marketing authorization applications (MAAs), and whether regulatory assessment of PG‐PK interaction...

Descripción completa

Detalles Bibliográficos
Autores principales:	Maliepaard, Marc, Toiviainen, Timi, De Bruin, Marie L., Meulendijks, Didier
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2020
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7484984/ https://www.ncbi.nlm.nih.gov/pubmed/32236952 http://dx.doi.org/10.1002/cpt.1834

Ejemplares similares

Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency
por: Maliepaard, Marc, et al.
Publicado: (2022)

Post‐Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004–2014
por: Cherla, Avi, et al.
Publicado: (2022)

Reported hepatotoxicity and hepatotoxicity guidance in the product information of protein kinase inhibitors in oncology registered at the European Medicines Agency
por: Maliepaard, Marc, et al.
Publicado: (2023)

Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency
por: Elsäßer, Amelie, et al.
Publicado: (2014)

Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?
por: Flynn, Robert, et al.
Publicado: (2021)

Dose selection and tolerability of anticancer agents evaluated by the European Medicines Agency in the period 2015-2020
por: Maliepaard, M., et al.
Publicado: (2021)

Review and comparison of clinical evidence submitted to support European Medicines Agency market authorization of orphan-designated oncological treatments
por: Winstone, Julie, et al.
Publicado: (2015)

Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency
por: Dekker, Marieke J. H. J., et al.
Publicado: (2021)

The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines
por: Cavaleri, Marco, et al.
Publicado: (2021)

European Medicines Agency review of midostaurin (Rydapt) for the treatment of adult patients with acute myeloid leukaemia and systemic mastocytosis
por: Tzogani, Kyriaki, et al.
Publicado: (2019)

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)

Mobility endpoints in marketing authorisation of drugs: what gets the European medicines agency moving?
por: Jaeger, Simon U, et al.
Publicado: (2022)

Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency
por: Collignon, Olivier, et al.
Publicado: (2018)

Patient-Reported Outcome Measures in Oncology Drugs Approved by the European Medicines Agency, 2017-2021
por: Ciani, Oriana, et al.
Publicado: (2023)

Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017–2022
por: Ciani, Oriana, et al.
Publicado: (2023)

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)

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)

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)

Effects of Pharmacogenetics on the Pharmacokinetics and Pharmacodynamics of Tamoxifen
por: de Vries Schultink, Aurelia H. M., et al.
Publicado: (2015)

Insights into the Pharmacogenetics of Tacrolimus Pharmacokinetics and Pharmacodynamics
por: Brunet, Mercè, et al.
Publicado: (2022)

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

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 Experience With Biowaivers in Centralized Applications
por: Lenić, Ines, et al.
Publicado: (2019)

Ticagrelor: Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Profile: An Update
por: Teng, Renli
Publicado: (2015)

Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of Tacrolimus in Kidney Transplantation
por: Yu, Meng, 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)

Pharmacogenetics: The future medicine
por: Saini, Rajiv, et al.
Publicado: (2010)

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)

Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency
por: Ayalew, Kassa, et al.
Publicado: (2022)

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

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

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

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

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

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

EHPnet: European Chemicals Agency
por: Dooley, Erin E.
Publicado: (2008)

Pharmacokinetic, pharmacodynamic, and pharmacogenetic assays to monitor clopidogrel therapy
por: Alvitigala, Bhawani Yasassri, et al.
Publicado: (2020)

Interchangeability of Generics—Experiences and Outlook Toward Pharmacokinetics Variability and Generic‐Generic Substitution
por: Yu, Yang, et al.
Publicado: (2018)

Cannot write session to /tmp/vufind_sessions/sess_2fcb1144s7vju1bf332oaqficc