Deborah Layton
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View article: Incidence of Diabetic Ketoacidosis in Dapagliflozin‐Treated Japanese Patients With Type 1 Diabetes Mellitus: An Observational Cohort Database Study
Incidence of Diabetic Ketoacidosis in Dapagliflozin‐Treated Japanese Patients With Type 1 Diabetes Mellitus: An Observational Cohort Database Study Open
Purpose Diabetic ketoacidosis (DKA) is an important identified risk of treatment with the sodium‐glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin, particularly in patients with type 1 diabetes mellitus (T1DM). We evaluated the DKA …
View article: Epidemiology of Thrombotic Thrombocytopenia Syndrome 2011 to 2022: English Sentinel Network Cohort Studies
Epidemiology of Thrombotic Thrombocytopenia Syndrome 2011 to 2022: English Sentinel Network Cohort Studies Open
Our study, using a previous definition of TTS, reinforces the very rare nature of TTS before and during the pandemic, and before and after the introduction of the AZD1222 vaccine; it also confirms the established very low incident event ra…
View article: Cancer Therapy-Induced Cardiotoxicity: Results of the Analysis of the UK DEFINE Database
Cancer Therapy-Induced Cardiotoxicity: Results of the Analysis of the UK DEFINE Database Open
Background: The accelerated development of novel cancer therapies necessitates a thorough understanding of the associated cardiotoxicity profiles, due to their significant implications for the long-term health and quality of life of cancer…
View article: Cancer-Therapy-Induced Cardiotoxicity: Results of the Analysis of the UK Yellow Card Adverse Drug Reaction (ADR) Reporting
Cancer-Therapy-Induced Cardiotoxicity: Results of the Analysis of the UK Yellow Card Adverse Drug Reaction (ADR) Reporting Open
Background: Non-small cell lung cancer (NSCLC) is a predominant cause of oncological mortality in the United Kingdom. There is a diverse spectrum of therapeutic options available, such as chemotherapies, targeted therapies and immunotherap…
View article: Contemporary Practice and Considerations for Real‐World Data Source Identification and Feasibility Assessment
Contemporary Practice and Considerations for Real‐World Data Source Identification and Feasibility Assessment Open
Purpose There has been rapid growth in the variety and number of real‐world data (RWD) sources, as well as the number of regulatory documents that provide guidance for assessing the suitability of RWD sources for pharmacoepidemiology studi…
View article: Use of quantitative bias analysis to evaluate single‐arm trials with real‐world data external controls
Use of quantitative bias analysis to evaluate single‐arm trials with real‐world data external controls Open
Purpose Use of real‐world data (RWD) for external controls added to single‐arm trials (SAT) is increasingly prevalent in regulatory submissions. Due to inherent differences in the data‐generating mechanisms, biases can arise. This paper ai…
View article: Updated core competencies in pharmacoepidemiology to inform contemporary curricula and training for academia, government, and industry
Updated core competencies in pharmacoepidemiology to inform contemporary curricula and training for academia, government, and industry Open
Purpose The first paper to specify the core content of pharmacoepidemiology as a profession was published by an ISPE (International Society for Pharmacoepidemiology) workgroup in 2012 (Jones JK et al. PDS 2012; 21[7]:677–689). Due to the b…
View article: Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review
Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review Open
Introduction: In the last few decades, there has been a rapid development in cancer therapies and improved detection strategies, hence the death rates caused by cancer have decreased. However, it has been reported that cardiovascular disea…
View article: Issue Information
Issue Information Open
Higher levels of von Willebrand factor in hospitalised patient plasma provides an explanation for the association of ABO
View article: Overview of the <scp>European post‐authorisation study</scp> register post‐authorization studies performed in Europe from September 2010 to December 2018
Overview of the <span>European post‐authorisation study</span> register post‐authorization studies performed in Europe from September 2010 to December 2018 Open
Background The European post‐authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency (EMA). All EMA‐requested PAS, commonly observational studies, must be recorded in this register. Multi‐dat…
View article: A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data
A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data Open
Several approaches have been proposed recently to accelerate the pathway from drug discovery to patient access. These include novel designs such as using controls external to the clinical trial where standard randomised controls are not fe…
View article: Drugs and life-threatening ventricular arrhythmia risk: results from the DARE study cohort
Drugs and life-threatening ventricular arrhythmia risk: results from the DARE study cohort Open
Objectives To establish a unique sample of proarrhythmia cases, determine the characteristics of cases and estimate the contribution of individual drugs to the incidence of proarrhythmia within these cases. Setting Suspected proarrhythmia …
View article: Biotechnology and Bioengineering: Volume 113, Number 8, August 2016
Biotechnology and Bioengineering: Volume 113, Number 8, August 2016 Open
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View article: Utilisation and Tolerability of Aliskiren in the Primary Care Setting in England
Utilisation and Tolerability of Aliskiren in the Primary Care Setting in England Open
Aliskiren (Rasilez), a direct renin inhibitor, is indicated for the treatment of essential hypertension. A postmarketing prescription‐event monitoring ( PEM ) study was conducted in England to monitor the safety and utilization of aliskire…
View article: Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England
Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England Open
The pilot study showed no significant change in reactogenicity or other apparent safety signals from the data collected. Continued enhanced surveillance of seasonal influenza vaccines will ensure their ongoing safety for the prevention of …
View article: Specialist Cohort Event Monitoring Studies: A New Study Method for Risk Management in Pharmacovigilance
Specialist Cohort Event Monitoring Studies: A New Study Method for Risk Management in Pharmacovigilance Open
The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for 'real-world' post-authorization safety studies (PASS) that not only align with risk management objectives to g…