Zobrazeno 1 - 10
of 14
pro vyhledávání: '"Kelly Plueschke"'
Publikováno v:
Frontiers in Pharmacology, Vol 13 (2022)
Between 2000 and 2021, the European Medicines Agency (EMA) assigned the orphan designation to over 1,900 medicines. Due to their small target populations, leading to challenges regarding clinical trial recruitment, study design and little knowledge o
Externí odkaz:
https://doaj.org/article/c8802a5bb27f4f60947bf5660b93552c
Autor:
Piotr Szymański, Franz Weidinger, Isabelle Lordereau-Richard, Anders Himmelmann, Marcello Arca, Jose Chaves, Charles Lee, Carla Jonker, Dipak Kotecha, James O'Kelly, Kelly Plueschke, Andrzej Ryś, Andrej Segec, Lars Wallentin, Rogier Veltrop, Stefan James
Publikováno v:
European heart journal-Quality of care & clinical outcomes, 9(2), 109-118. Oxford University Press
Real world data (RWD) refers to healthcare information that is routinely collected in electronic healthcare records (EHR), hospital and pharmacy records, patient and disease registries, and health insurance databases. The collection and analysis of t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::68d148d94bfdb8f913e509429e879588
https://doi.org/10.1093/ehjqcco/qcad009
https://doi.org/10.1093/ehjqcco/qcad009
Autor:
Elisabeth Bakker, Kelly Plueschke, Carla J. Jonker, Xavier Kurz, Viktoriia Starokozhko, Peter G. M. Mol
Publikováno v:
Clinical Pharmacology & Therapeutics, 113(1), 135-151. Nature Publishing Group
Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life cycle
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9d12ce57148839066800fb07819fe443
https://doi.org/10.1002/cpt.2766
https://doi.org/10.1002/cpt.2766
Publikováno v:
Drug Safety. 45:747-754
As patient registries are not subject to regulatory requirements on the collection of adverse events (AEs) related to medicinal products, they may not have foreseen the collection of such information on a routine basis or as part of specific data col
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::89e1945f27d5b84f9be8c6cf183adfdc
https://doi.org/10.1007/s40264-022-01188-x
https://doi.org/10.1007/s40264-022-01188-x
Autor:
Kelly Plueschke, Robert Flynn, Karin Hedenmalm, Aikaterini-Christina Deli, Miguel-Angel Maciá-Martinez, Patricia García-Poza, David Olsen, Pierre Nguyen, Chantal Quinten
Publikováno v:
Drug safety. 45(10)
Concerns over serious respiratory depression in children led to two European Union (EU) referral procedures (in 2013 and 2015) to review the benefit-risk balance of codeine in this population when used for pain relief, cough or cold. Consequently, co
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fdf6fc5ac7c8afd72421596f75dbb833
https://pubmed.ncbi.nlm.nih.gov/36001288
https://pubmed.ncbi.nlm.nih.gov/36001288
Autor:
Justina Januskiene, Kelly Plueschke, Andrej Segec, Xavier Kurz, Jim Slattery, Peter Arlett, Georgy Genov
Publikováno v:
Pharmacoepidemiology and Drug Safety
Background The additional monitoring (AM)/black triangle concept is aimed to enhance ADR reporting for certain types of medicinal products for which the safety profile is less well established. Purpose The objective of this survey was to assess (a) a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1df99944d32964bbde81de3dee3ebe0b
https://doi.org/10.1002/pds.5162
https://doi.org/10.1002/pds.5162
Autor:
Ruben G Duijnhoven, Kelly Plueschke, María Gordillo-Marañón, Chantal Quinten, Valerie Strassmann, Catherine Cohet, Robert W. V. Flynn, Xavier Kurz, Marcia Rueckbeil
Publikováno v:
Clinical pharmacology & therapeutics 111(1), 90-97 (2021). doi:10.1002/cpt.2461
Clinical pharmacology & therapeutics : CPT 111(1), 90-97 (2022). doi:10.1002/cpt.2461
Published by Wiley-Blackwell, Hoboken, NJ
Published by Wiley-Blackwell, Hoboken, NJ
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3b6d64359919c795ae1c182e68e902c1
Autor:
Mireia Castillon, Xavier Kurz, Peter G. M. Mol, Daniel Nogueras Zondag, Priya Bahri, Carla Alonso Olmo, Kelly Plueschke, Patricia McGettigan
Publikováno v:
Drug Safety, 42(12), 1517-1518. ADIS INT LTD
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8bb129a9fa7330b1d8f90239e9c27e99
https://research.rug.nl/en/publications/31f52c65-84d5-46bb-82fe-de28f3d2c4cb
https://research.rug.nl/en/publications/31f52c65-84d5-46bb-82fe-de28f3d2c4cb
Autor:
Priya Bahri, Mireia Castillon, Xavier Kurz, Kelly Plueschke, Peter G. M. Mol, Daniel Nogueras Zondag, Carla Alonso Olmo, Patricia McGettigan
Publikováno v:
Drug Safety, 42(11), 1343-1351. ADIS INT LTD
Drug Safety
Drug Safety
Introduction Patient registries, ‘organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time’, are potentially valuable sources
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::04c3df2c7bd0ae1ae08b4c82c6a33fcc
https://research.rug.nl/en/publications/e793a2be-794d-4f01-abfb-7e631867151d
https://research.rug.nl/en/publications/e793a2be-794d-4f01-abfb-7e631867151d
Publikováno v:
Pharmacoepidemiology and Drug Safety, 27(7), 823-826. John Wiley & Sons Ltd.
textabstractPurpose: Building on previous research, we examined whether delayed study start and low patient accrual rates found in 31 postauthorization registry-based studies requested by European Medicines Agency (EMA) are maintained after 2 additio
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e896a0fd1bbfa2351569dea4e0126ced
https://pubmed.ncbi.nlm.nih.gov/29749086
https://pubmed.ncbi.nlm.nih.gov/29749086