Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice

Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland

(2018) J. O’Callaghan et al.   BIODRUGS

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

(2018) Ross A. McKinnon et al.   BIODRUGS

Challenges and Opportunities for the Traceability of (Biological) Medicinal Products

(2018) Kevin Klein et al.   DRUG SAFETY

Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges

(2018) Corrado Blandizzi et al.   PHARMACOLOGICAL RESEARCH

Biosimilars: Concepts and controversies

(2018) Reyes Gámez-Belmonte et al.   PHARMACOLOGICAL RESEARCH

Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents

(2016) Balázs Vezér et al.   CURRENT MEDICAL RESEARCH AND OPINION

Drug-induced progressive multifocal leukoencephalopathy: Lessons learned from contrasting natalizumab and rituximab

(2015) NS Vermeer et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports

(2015) Kevin Klein et al.   DRUG SAFETY

The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study

(2015) Niels S. Vermeer et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing

(2014) Sundar Ramanan et al.   BIODRUGS

Biosimilars: the science of extrapolation

(2014) M. Weise et al.   BLOOD

Safety Profile of Biological Medicines as Compared with Non-Biologicals: An Analysis of the Italian Spontaneous Reporting System Database

(2014) Paola M. Cutroneo et al.   DRUG SAFETY

Traceability of biologicals: present challenges in pharmacovigilance

(2014) Niels S Vermeer et al.   Expert Opinion On Drug Safety

Thrombotic Microangiopathy Associated with Interferon Beta

(2014) David Hunt et al.   NEW ENGLAND JOURNAL OF MEDICINE

Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases

(2013) Niels S. Vermeer et al.   DRUG SAFETY

Tiotropium Respimat Inhaler and the Risk of Death in COPD

(2013) Robert A. Wise et al.   NEW ENGLAND JOURNAL OF MEDICINE

Biosimilars: what clinicians should know

(2012) M. Weise et al.   BLOOD

Pharmacovigilance of Biopharmaceuticals

(2009) Thijs J. Giezen et al.   DRUG SAFETY