Search results: Sage Journals

Open accessReview articleFirst 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

Restricted accessResearch articleFirst published July, 2016

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

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

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published November, 2015

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

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

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published September, 2008

VigiBase,the WHO Global ICSR Database System: Basic Facts

Marie Lindquist

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published August, 2001

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 accessResearch articleFirst published August, 2025

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 accessReview articleFirst published 2020

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

Marina A. Malikova

Therapeutic Advances in Drug Safety

Restricted accessResearch articleFirst published November, 2014

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 accessResearch articleFirst published March, 2024

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

Tomás Estevinho, Egídio Freitas, Tiago Torres

Journal of International Medical Research

Free accessReview articleFirst published October, 2013

Monitoring product safety in the postmarketing environment

Robert G Sharrar, Gretchen S Dieck

Therapeutic Advances in Drug Safety

Open accessReview articleFirst 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

Restricted accessResearch articleFirst published July, 2016

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

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

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published November, 2015

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

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

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published September, 2008

VigiBase,the WHO Global ICSR Database System: Basic Facts

Marie Lindquist

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published August, 2001

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 accessResearch articleFirst published August, 2025

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 accessReview articleFirst published 2020

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

Marina A. Malikova

Therapeutic Advances in Drug Safety

Restricted accessResearch articleFirst published November, 2014

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 accessResearch articleFirst published March, 2024

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

Tomás Estevinho, Egídio Freitas, Tiago Torres

Journal of International Medical Research

Free accessReview articleFirst published October, 2013

Monitoring product safety in the postmarketing environment

Robert G Sharrar, Gretchen S Dieck

Therapeutic Advances in Drug Safety