Search Results - "Layton, Deborah"

Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review by Chan, Stefanie Ho Yi, Khatib, Yasmin, Webley, Sherael, Layton, Deborah, Salek, Sam

“…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…”
Get full text

Drugs and life-threatening ventricular arrhythmia risk: results from the DARE study cohort by Coughtrie, Abigail L, Behr, Elijah R, Layton, Deborah, Marshall, Vanessa, Camm, A John, Shakir, Saad A W

“…ObjectivesTo establish a unique sample of proarrhythmia cases, determine the characteristics of cases and estimate the contribution of individual drugs to the…”
Get full text

Vulnerable Patients and Potential Harms: The Contribution of Observational Research by Layton, Deborah

“…In this edition of Drug Safety, Bloechliger et al present the results of their pharmacoepidemiological study that describes an evaluation of the risk of…”
Get full text

A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data by Gray, Christen M., Grimson, Fiona, Layton, Deborah, Pocock, Stuart, Kim, Joseph

“…Several approaches have been proposed recently to accelerate the pathway from drug discovery to patient access. These include novel designs such as using…”
Get full text

Safety profile of raloxifene as used in general practice in England: results of a prescription-event monitoring study by LAYTON, Deborah, CLARKE, Andrea, WILTON, Lynda V, SHAKIR, Saad A. W

“…Raloxifene, a selective estrogen receptor modulator (SERM) licensed for the prevention of non-traumatic vertebral fractures in postmenopausal women at…”
Get full text

Letters by Layton, Deborah

Get full text

Contemporary Practice and Considerations for Real‐World Data Source Identification and Feasibility Assessment by Patel, Dony, Guleria, Sonia, Titievsky, Lina, Flaherty, Susanna, Everage, Nicholas, Korjagina, Marta, Porkess, Sheuli, Kou, Tzuyung Douglas, Layton, Deborah

“…ABSTRACT 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…”
Get full text

Correction to: A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project by Pereira, Leonardo Roque, Durán, Carlos E., Layton, Deborah, Poulentzas, Georgios, Lalagkas, Panagiotis-Nikolaos, Kontogiorgis, Christos, Sturkenboom, Miriam

Get full text

Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends by Ly, Nelly F., Flach, Clare, Lysen, Thom S., Markov, Emanuil, van Ballegooijen, Hanne, Rijnbeek, Peter, Duarte-Salles, Talita, Reyes, Carlen, John, Luis H., Karimi, Leila, Reich, Christian, Salek, Sam, Layton, Deborah

“…Introduction Concerns of the persistence and severity of the adverse effects of fluoroquinolones, mainly involving the nervous system, muscles and joints,…”
Get full text

A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project by Roque Pereira, Leonardo, Durán, Carlos E., Layton, Deborah, Poulentzas, Georgios, Lalagkas, Panagiotis-Nikolaos, Kontogiorgis, Christos, Sturkenboom, Miriam

“…Introduction A large proportion of medicine product labels lack information on safety in pregnancy and breastfeeding. To address this gap, pharmaceutical…”
Get full text

Use of quantitative bias analysis to evaluate single‐arm trials with real‐world data external controls by Gray, Christen, Ralphs, Eleanor, Fox, Matthew P., Lash, Timothy L., Liu, Geoffrey, Kou, Tzuyung Doug, Rivera, Donna R., Bosco, Jaclyn, Braun, Kim Van Naarden, Grimson, Fiona, Layton, Deborah

“…Purpose Use of real‐world data (RWD) for external controls added to single‐arm trials (SAT) is increasingly prevalent in regulatory submissions. Due to…”
Get full text

Updated core competencies in pharmacoepidemiology to inform contemporary curricula and training for academia, government, and industry by Osborne, Vicki, Goodin, Amie, Brown, Joshua, Winterstein, Almut G., Bate, Andrew, Cohet, Catherine, Pont, Lisa, Moeny, David, Klungel, Olaf, Pinheiro, Simone, Seeger, John, Chan, K. Arnold, Edlavitch, Stanley, Tilson, Hugh, Layton, Deborah

“…Purpose The first paper to specify the core content of pharmacoepidemiology as a profession was published by an ISPE (International Society for…”
Get full text

110Working with community pharmacists to improve anticoagulation new medicine service discussions by Gordon, Sharron, Rowse, Vicki, Williams, Elizabeth, Corteville, Liz, Layton, Deborah

Get full text

Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England by McNaughton, Rhian, Lynn, Elizabeth, Osborne, Vicki, Coughtrie, Abigail, Layton, Deborah, Shakir, Saad

“…Introduction Fluenz Tetra is an intranasal quadrivalent live attenuated influenza vaccine (QLAIV) and is recommended as the vaccine of choice for children in…”
Get full text

Specialist Cohort Event Monitoring Studies: A New Study Method for Risk Management in Pharmacovigilance by Layton, Deborah, Shakir, Saad A. W.

“…The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for ‘real-world’…”
Get full text

Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England by Osborne, Vicki, Davies, Miranda, Layton, Deborah, Shakir, Saad A. W.

“…Introduction Deferasirox (EXJADE ® , Novartis, UK) is an oral iron-chelating agent primarily used to reduce chronic iron overload in patients receiving blood…”
Get full text

Overview of the European post‐authorisation study register post‐authorization studies performed in Europe from September 2010 to December 2018 by Sultana, Janet, Crisafulli, Salvatore, Almas, Mariana, Antonazzo, Ippazio Cosimo, Baan, Esme, Bartolini, Claudia, Bertuccio, Maria Paola, Bonifazi, Fedele, Capuano, Annalisa, Didio, Antonella, Ehrenstein, Vera, Felisi, Mariagrazia, Ferrajolo, Carmen, Fontana, Andrea, Francisca, Remy, Fourrier‐Reglat, Annie, Fortuny, Joan, Gini, Rosa, Hyeraci, Giulia, Hoeve, Christel, Kontogiorgis, Christos, Isgrò, Valentina, Lalagkas, Panagiotis‐Nikolaos, L'Abbate, Luca, Layton, Deborah, Landi, Annalisa, Narduzzi, Silvia, Roque Pereira, Leonardo, Poulentzas, Georgios, Rafaniello, Concetta, Roberto, Giuseppe, Scondotto, Giulia, Sportiello, Liberata, Toma, Maddalena, Toussi, Massoud, Verhamme, Katia, Volpe, Elisabetta, Trifirò, Gianluca

“…Background The European post‐authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency (EMA). All EMA‐requested…”
Get full text

Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self‐reporting of serious adverse events and pregnancy outcomes by Mackenzie, Isla S., MacDonald, Thomas M., Shakir, Saad, Dryburgh, Moira, Mantay, Brian J., McDonnell, Patrick, Layton, Deborah

“…WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • While the new H1N1 vaccines underwent the usual rigorous safety and efficacy testing, concerns remained that there…”
Get full text

Overview of the EU PAS register post-authorization studies performed in Europe from September 2010 to December 2018 by Sultana, Janet, Crisafulli, Salvatore, Almas, Mariana, Antonazzo, Ippazio Cosimo, Baan, Esme, Bartolini, Claudia, Bertuccio, Maria Paola, Bonifazi, Fedele, Capuano, Annalisa, Didio, Antonella, Ehrenstein, Vera, Felisi, Mariagrazia, Ferrajolo, Carmen, Fontana, Andrea, Francisca, Remy, Fourrier-Reglat, Annie, Fortuny, Joan, Gini, Rosa, Hyeraci, Giulia, Hoeve, Christel, Kontogiorgis, Christos, Isgro, Valentina, Lalagkas, Panagiotis-Nikolaos, L'Abbate, Luca, Layton, Deborah, Landi, Annalisa, Narduzzi, Silvia, Pereira, Leonardo Roque, Poulentzas, Georgios, Rafaniello, Concetta, Roberto, Giuseppe, Scondotto, Giulia, Sportiello, Liberata, Toma, Maddalena, Toussi, Massoud, Verhamme, Katia, Volpe, Elisabetta, Trifiro, Gianluca

“…BACKGROUND: The European post-authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency (EMA). All EMA-requested…”
Get full text

Modified Prescription-Event Monitoring Studies: A Tool for Pharmacovigilance and Risk Management by Layton, Deborah, Hazell, Lorna, Shakir, Saad A.W.

“…Prescription-Event Monitoring (PEM) is a well established postmarketing surveillance technique designed to monitor the overall safety of newly marketed…”
Get full text