Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Cecile, Ollivier"'
Publikováno v:
Clinical Pharmacology & Therapeutics. 111:799-806
Global regulatory agencies have transformed their approach to approvals in their processes for formal review of the safety and efficacy of new drugs. Opportunities for innovation have expanded because of the coronavirus disease 2019 (COVID-19) pandem
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c2ca550576127975d88dc8b55ab5b7e3
https://doi.org/10.1002/cpt.2528
https://doi.org/10.1002/cpt.2528
Autor:
Andrew E. Mulberg, Laurie S. Conklin, Nicholas M. Croft, Anushree Parikh, Athos Bousvaros, Edwin DeZoeten, Marla Dubinsky, Francisco Javier Martin Carpi, Hankje Escher, Richard Vesely, Cecile Ollivier, Wallace Crandall, Collin Hovinga
Publikováno v:
Gastroenterology, 163(1), 77-83. W.B. Saunders
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4ad67411433358aaa46dea973f5a7715
https://pure.eur.nl/en/publications/4497e476-ee73-454d-b35c-857d1b061414
https://pure.eur.nl/en/publications/4497e476-ee73-454d-b35c-857d1b061414
Autor:
Sharon Sakai, Adora Ndu, Cecile Ollivier, Jerry Vockley, Keith Gregg, Veronica Miller, Mahta Jahanshahi, Tanja Franolic, Gillian Davis
Publikováno v:
Therapeutic Innovation & Regulatory Science
The regulatory standards of the United States Food and Drug Administration (FDA) require substantial evidence of effectiveness from adequate and well-controlled trials that typically use a valid comparison to an internal concurrent control. However,
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a46f89489b73b91ae98eeaf3bdc25613
https://doi.org/10.1007/s43441-021-00302-y
https://doi.org/10.1007/s43441-021-00302-y
Autor:
Aimee Donald, Obuchinezia Anyanwu, Anna Mayhew, Victoria Harbottle, Elin Haf Davies, Cecile Ollivier, Flora McErlane
Publikováno v:
Therapeutic Innovation & Regulatory Science. 55:799-806
To determine the utility of wearable technologies in physical activity assessment in three paediatric diseases, namely, Niemann-Pick C (NP-C), Juvenile Idiopathic Arthritis (JIA) and Duchenne Muscular Dystrophy (DMD). Exploratory study Thirty childre
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5025f69e3dca87775c09a7673e5be677
https://doi.org/10.1007/s43441-021-00278-9
https://doi.org/10.1007/s43441-021-00278-9
Autor:
Flora, McErlane, Elin Haf, Davies, Cecile, Ollivier, Anna, Mayhew, Obuchinezia, Anyanwu, Victoria, Harbottle, Aimee, Donald
Publikováno v:
Therapeutic innovationregulatory science. 55(4)
To determine the utility of wearable technologies in physical activity assessment in three paediatric diseases, namely, Niemann-Pick C (NP-C), Juvenile Idiopathic Arthritis (JIA) and Duchenne Muscular Dystrophy (DMD).Exploratory study SETTING AND PAT
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::9c36316eb35d8c9c5d966660693361c7
https://pubmed.ncbi.nlm.nih.gov/33844190
https://pubmed.ncbi.nlm.nih.gov/33844190
Autor:
Aimee Donald, Elin Haf Davies, Victoria Harbottle, Anna Mayhew, Obuchinezia Anyanwu, Cecile Ollivier, Flora McErlane
ObjectiveTo determine the feasibility of wearable technologies in physical activity assessment in three paediatric diseases, namely Niemann-Pick C (NP-C), Juvenile Idiopathic Arthritis (JIA) and Duchenne Muscular Dystrophy (DMD).DesignProof of concep
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::acc787f192c01da116b9ae1db85a3168
https://doi.org/10.1101/2020.10.25.20219139
https://doi.org/10.1101/2020.10.25.20219139
Autor:
Christina Bucci-Rechtweg, S.Y. Amy Cheung, Janina Karres, Margaret Gamalo-Siebers, Jan Marquard, Cecile Ollivier, Ashley Strougo, Lynne Yao, Jeffrey S. Barrett, Yeruk Mulugeta, Sebastian Haertter, Lisa Yanoff, Philip Zeitler
Publikováno v:
Clinical Pharmacology and Therapeutics
Extrapolation from adults to youth with type 2 diabetes (T2D) is challenged by differences in disease progression and manifestation. This manuscript presents the results of a mock-team workshop focused on examining the typical team-based decision pro
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ab999181aa7828bc131287c917ac5f50
https://pubmed.ncbi.nlm.nih.gov/32017043
https://pubmed.ncbi.nlm.nih.gov/32017043
Autor:
Kevin Blake, Kristin E. Karlsson, Cecile Ollivier, Gérard Pons, Andrew Thomson, Robert Hemmings, Catherijne A. J. Knibbe, Efthymios Manolis
Publikováno v:
British Journal of Clinical Pharmacology, 85(4), 659-668. WILEY
Adopted guidelines reflect a harmonised European approach to a specific scientific issue and should reflect the most recent scientific knowledge. However, whilst EU regulations are mandatory for all member states and EU directives must be followed by
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c0a0542e70f2e9df6666f8df6b8da9f1
https://hdl.handle.net/1887/3200411
https://hdl.handle.net/1887/3200411
Legislative initiatives have been successful in increasing the availability of approved therapies for paediatric patients. However, additional measures to ensure the timely completion of paediatric studies are necessary to further increase the number
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dc6c5cc67a355033ed119461861932d6
https://europepmc.org/articles/PMC6422664/
https://europepmc.org/articles/PMC6422664/
Autor:
Flora Musuamba Tshinanu, Frederike Lentz, Wei Zhao, Anna Karin Hamberg, Norbert Benda, Joseph F. Standing, Cecile Ollivier, Andrew Thomson, Sofia Friberg Hietala, Efthymios Manolis, Gérard Pons, Susan Cole, Paolo Tomasi, Ine Skottheim Rusten, María J. Garrido, Valeria Gigante, Ralf Herold, Anna Nordmark, Johannes Taminiau
Publikováno v:
Fundamentals of Pediatric Drug Dosing ISBN: 9783319437521
For a paediatric development to be rationally informed by all available knowledge, it is necessary to systematically collect and learn from available data, expert knowledge and prior developments. Aspects such as drug formulation, bioanalytical metho
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5211cde2b733f8349acdf1c43ee24f18
https://doi.org/10.1007/978-3-319-43754-5_7
https://doi.org/10.1007/978-3-319-43754-5_7