Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks-Reference-Cited by-同舟云学术

Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks

Published:2021-07-15 Issue:11 Volume:20 Page:1433-1442
ISSN:1474-0338
Container-title:Expert Opinion on Drug Safety
language:en
Short-container-title:Expert Opinion on Drug Safety

Author:

Bloem Lourens T.¹²^ORCID,Karomi Mariana¹,Hoekman Jarno¹³,van der Elst Menno E.²,Leufkens Hubert G.M.¹,Klungel Olaf H.¹⁴,Mantel-Teeuwisse Aukje K.¹^ORCID

Affiliation:

1. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands

2. Pharmacovigilance department, Dutch Medicines Evaluation Board, Utrecht, The Netherlands

3. Pharmacovigilance department, Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The Netherlands

4. Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/14740338.2021.1952981

Reference54 articles.

1. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma

2. Observational Research, Randomised Trials, and Two Views of Medical Science

3. Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

4. Extensions of indication throughout the drug product lifecycle: a quantitative analysis

5. Towards Drug Safety Surveillance and Pharmacovigilance: Current Progress in Detecting Medication and Adverse Drug Events from Electronic Health Records

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