Literature DB >> 31378846

Good Pharmacovigilance Practice in Paediatrics: An Overview of the Updated European Medicines Agency Guidelines.

Janet Sultana1, Cosimo Zaccaria2, Roberto de Lisa3, Francesco Rossi4,5, Annalisa Capuano4,5, Carmen Ferrajolo6,7.   

Abstract

Year:  2019        PMID: 31378846     DOI: 10.1007/s40272-019-00350-w

Source DB:  PubMed          Journal:  Paediatr Drugs        ISSN: 1174-5878            Impact factor:   3.022


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  7 in total

Review 1.  The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?

Authors:  Gianluca Trifirò; Rosa Gini; Francesco Barone-Adesi; Ettore Beghi; Anna Cantarutti; Annalisa Capuano; Carla Carnovale; Antonio Clavenna; Mirosa Dellagiovanna; Carmen Ferrajolo; Matteo Franchi; Ylenia Ingrasciotta; Ursula Kirchmayer; Francesco Lapi; Roberto Leone; Olivia Leoni; Ersilia Lucenteforte; Ugo Moretti; Alessandro Mugelli; Luigi Naldi; Elisabetta Poluzzi; Concita Rafaniello; Federico Rea; Janet Sultana; Mauro Tettamanti; Giuseppe Traversa; Alfredo Vannacci; Lorenzo Mantovani; Giovanni Corrao
Journal:  Drug Saf       Date:  2019-03       Impact factor: 5.606

2.  Discretely Integrated Condition Event (DICE) Simulation for Pharmacoeconomics.

Authors:  J Jaime Caro
Journal:  Pharmacoeconomics       Date:  2016-07       Impact factor: 4.981

3.  Assessing Drug Safety in Children - The Role of Real-World Data.

Authors:  Ann W McMahon; Gerald Dal Pan
Journal:  N Engl J Med       Date:  2018-06-07       Impact factor: 91.245

4.  Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States.

Authors:  Dobromir Penkov; Paolo Tomasi; Irmgard Eichler; Dianne Murphy; Lynne P Yao; Jean Temeck
Journal:  Ther Innov Regul Sci       Date:  2017-05-01       Impact factor: 1.778

5.  Comparison between paediatric and adult suspected adverse drug reactions reported to the European medicines agency: implications for pharmacovigilance.

Authors:  Kevin V Blake; Cosimo Zaccaria; Francois Domergue; Edith La Mache; Agnes Saint-Raymond; Ana Hidalgo-Simon
Journal:  Paediatr Drugs       Date:  2014-08       Impact factor: 3.930

6.  Cardiovascular screening to reduce the burden from cardiovascular disease: microsimulation study to quantify policy options.

Authors:  Chris Kypridemos; Kirk Allen; Graeme L Hickey; Maria Guzman-Castillo; Piotr Bandosz; Iain Buchan; Simon Capewell; Martin O'Flaherty
Journal:  BMJ       Date:  2016-06-08

7.  In the Real-World, Kids Use Medications and Devices.

Authors:  Tamar Lasky
Journal:  Drugs Real World Outcomes       Date:  2017-06
  7 in total
  1 in total

1.  Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System.

Authors:  Annamaria Mascolo; Cristina Scavone; Michele Bertini; Simona Brusco; Francesca Punzo; Elvira Pota; Martina Di Martino; Daniela Di Pinto; Francesca Rossi
Journal:  Front Pharmacol       Date:  2020-05-07       Impact factor: 5.810

  1 in total

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