Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012-Reference-Cited by-同舟云学术

Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012

Published:2016-05-04 Issue:9 Volume:25 Page:1004-1014
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Bouvy Jacoline C.¹²,Huinink Lotte²,De Bruin Marie L.¹

Affiliation:

1. Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science; Utrecht University; Utrecht The Netherlands

2. Institute for Medical Technology Assessment (iMTA), Faculty of Health, Policy and Management; Erasmus University Rotterdam; Rotterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference18 articles.

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2. Post-approval drug safety surveillance;Gibbons;Annu Rev Public Health,2010

3. Rägo L Santoso B Drug regulation: history, present and future. Chapter 6 from ‘Drug benefits and Risks: International Textbook of Clinical Pharmacology WHO’ 2nd edition 2008

4. A model for future conduct of pharmacovigilance;Waller;Pharmacoepidemiol Drug Saf,2003

5. Refining the benefit-risk framework for assessing medicines: valuing and weighting the parameters. Report on progress by regulators and industry on the development of a common benefit-risk assessment framework;Walker;Clin Pharm Ther,2011

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1. Global Landscape of Benefit–Risk Considerations for Medicinal Products: Current State and Future Directions;Pharmaceutical Medicine;2022-07-03

2. Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks;Expert Opinion on Drug Safety;2021-07-15

3. A description of medicines-related safety issues evaluated through a referral procedure at the EU level after 2012;Expert Opinion on Drug Safety;2020-03-31

4. Is pharmacovigilance of biologicals cost-effective?;International Journal of Clinical Pharmacy;2018-07-26

5. Pharmacovigilance of biosimilars and other biologicals within the hospital: current practices and future challenges;Generics and Biosimilars Initiative Journal;2017-03-15