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Open access

Review article

First published 2024

Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation

Antonio Lomeli-Silva, Homero Contreras-Salinas, Mayra Yolanda Barajas-Virgen [...]

Therapeutic Advances in Drug Safety

Retricted access

Research article

First published 2016-7

Best Practices for Improving the Quality of Individual Case Safety Reports in Pharmacovigilance

Rishi Kumar, Pranay Kumar, Vivekanandan Kalaiselvan [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2015-11

Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India

Kalaiselvan Vivekanandan, Arunabh Tripathi, Archana Saurabh [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2008-9

VigiBase,the WHO Global ICSR Database System: Basic Facts

Marie Lindquist

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2001-8

The joint pilot for the implementation of the electronic transmission of individual case safety reports between the EMEA,national Competent Authorities and Pharmaceutical Industry: The experience of the first six months

Sabine Brosch

Pharmaceuticals Policy and Law

Open access

Research article

First published 2025-8

Fluoroquinolones and risk of nightmares: A literature review and disproportionality analysis using individual case safety reports from Food and Drug Administration Adverse Event Reporting System database

Mohammad Ali Omrani, Christian T Tsobo, Niaz Chalabianloo [...]

Journal of Psychopharmacology

Open access

Review article

First published 2020

Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance

Marina A. Malikova

Therapeutic Advances in Drug Safety

Retricted access

Research article

First published 2014-11

Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND

Sundeep S. Sethi, Judith M. Kramer, Suzanne Gagnon [...]

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2024-3

Risankizumab,a therapeutic alternative for psoriasis in people living with HIV

Tomás Estevinho, Egídio Freitas, Tiago Torres

Journal of International Medical Research

Free access

Review article

First published 2013-10

Monitoring product safety in the postmarketing environment

Robert G Sharrar, Gretchen S Dieck

Therapeutic Advances in Drug Safety

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