Add to ORKGPurpose To describe and assess the outcomes of Peri-odic Safety Update Report (PSUR) evaluations of biopharmaceuticals. Methods A cross-sectional analysis was performed of follow-up requirements of PSURs submitted for central-ly approved biopharmaceuticals in the European Unio
Adverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from...
Regulatory decisions to allow new drugs on the market by definition have to accept a certain level o...
Introduction: Biological and biosimilar medicinal products have specific characteristics that call f...
PURPOSE: To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of ...
Background: Recent changes introduced to European legislation amend the requirements for the submiss...
Introduction: A periodic safety update report (PSUR), composed by marketing authorization holders an...
In the rapidly developing era of advanced of medical sciences, pharmacovigilance plays an important ...
IntroductionPeriodic Safety Update Reports (PSURs) are a key pharmacovigilance tool for the continuo...
Biopharmaceuticals differ from small molecules in terms of structure and pharmacology. Furthermore, ...
The Basel Pharmacoepidemiology Unit (BPU) is a research unit affiliated with the Institute of Clinic...
BACKGROUND: The characteristics of biopharmaceuticals may require a tailored approach to their safet...
Pharmacovigilance is an activity that provides protection to patients and public health. Problems re...
Prescription-Event Monitoring (PEM) is a well established postmarketing surveillance technique desig...
Biologics are used as effective therapeutics to treat a variety of diseases. Even though biologics a...
Background: Biologics are used as effective therapeutics to treat a variety of diseases. Even though...
Adverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from...
Regulatory decisions to allow new drugs on the market by definition have to accept a certain level o...
Introduction: Biological and biosimilar medicinal products have specific characteristics that call f...
PURPOSE: To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of ...
Background: Recent changes introduced to European legislation amend the requirements for the submiss...
Introduction: A periodic safety update report (PSUR), composed by marketing authorization holders an...
In the rapidly developing era of advanced of medical sciences, pharmacovigilance plays an important ...
IntroductionPeriodic Safety Update Reports (PSURs) are a key pharmacovigilance tool for the continuo...
Biopharmaceuticals differ from small molecules in terms of structure and pharmacology. Furthermore, ...
The Basel Pharmacoepidemiology Unit (BPU) is a research unit affiliated with the Institute of Clinic...
BACKGROUND: The characteristics of biopharmaceuticals may require a tailored approach to their safet...
Pharmacovigilance is an activity that provides protection to patients and public health. Problems re...
Prescription-Event Monitoring (PEM) is a well established postmarketing surveillance technique desig...
Biologics are used as effective therapeutics to treat a variety of diseases. Even though biologics a...
Background: Biologics are used as effective therapeutics to treat a variety of diseases. Even though...
Adverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from...
Regulatory decisions to allow new drugs on the market by definition have to accept a certain level o...
Introduction: Biological and biosimilar medicinal products have specific characteristics that call f...