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Drug Safety

Issue 10/2023

Content (9 Articles)

Editorial

Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach

Valentina Giunchi, Michele Fusaroli, Manfred Hauben, Emanuel Raschi, Elisabetta Poluzzi

Open Access Trastuzumab Deruxtecan Review Article

Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel

Joanne Wing Yan Chiu, Soo Chin Lee, James Chung-man Ho, Yeon Hee Park, Ta-Chung Chao, Sung-Bae Kim, Elgene Lim, Ching-Hung Lin, Sherene Loi, Su Ying Low, Lynette Li San Teo, Winnie Yeo, Rebecca Dent

Open Access Albendazole Original Research Article

Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study

Christabel Khaemba, Abbie Barry, Wyckliff P. Omondi, Elvis Kirui, Margaret Oluka, Gurumurthy Parthasarathi, Sammy M. Njenga, Anastacia Guantai, Eleni Aklillu

Original Research Article

Automated Classification of Quality Defect Issues Relating to Substandard Medicines Using a Hybrid Machine Learning and Rule-Based Approach

Desmond Chun Hwee Teo, Yiting Huang, Sreemanee Raaj Dorajoo, Michelle Sau Yuen Ng, Chih Tzer Choong, Doris Sock Tin Phuah, Dorothy Hooi Myn Tan, Filina Meixuan Tan, Huilin Huang, Maggie Siok Hwee Tan, Suan Tian Koh, Jalene Wang Woon Poh, Pei San Ang

Open Access Infliximab Original Research Article

Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies

Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Akimichi Morita, Mamitaro Ohtsuki, Yasuo Suzuki, Mamoru Watanabe, Hisashi Yamanaka, Toshifumi Hibi

Open Access Original Research Article

Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

Sharon C. M. Essink, Inge M. Zomerdijk, Sabine M. J. M. Straus, Helga Gardarsdottir, Marie L. De Bruin

Open Access Original Research Article

A Multi-method Exploratory Evaluation of a Service Designed to Improve Medication Safety for Patients with Monitored Dosage Systems Following Hospital Discharge

Fatema A. Alqenae, Douglas Steinke, Hilary Belither, Peter Robertson, Jennifer Bartlett, Jack Wilkinson, Steven D. Williams, Lawrence Brad, Mark Jeffries, Darren M. Ashcroft, Richard N. Keers

Open Access Direct Oral Anticoagulant Original Research Article

Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective

Jette A. van Lint, Marlieke Sonnenberg, Harald E. Vonkeman, Bart J. F. van den Bemt, Eugene P. van Puijenbroek, Naomi T. Jessurun