Zobrazeno 1 - 10
of 279
pro vyhledávání: '"Hans-Georg Eichler"'
Autor:
Maria Cavaller-Bellaubi, Wills Hughes-Wilson, Šárka Kubinová, Marc Van de Casteele, Evert Jan Van Lente, Emanuele Degortes, Johan Pontén, Hans-Georg Eichler, Yann Le Cam, Simone Boselli, Anna Bucsics
Publikováno v:
Orphanet Journal of Rare Diseases, Vol 18, Iss 1, Pp 1-11 (2023)
Abstract Background The Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) was established in 2013 with the intention of developing a coordinated mechanism between volunteering EU stakeholders and developers of Orphan Medicinal Produ
Externí odkaz:
https://doaj.org/article/90665d95cd5841749b192e562c59274a
Publikováno v:
Frontiers in Pharmacology, Vol 14 (2023)
Legislations incentivising orphan drug development and scientific advances have made orphan drugs pharma’s high-end favourite for the past two decades. Currently, around 50% of new marketing authorizations are for orphan drugs. For third-party heal
Externí odkaz:
https://doaj.org/article/550b127e400b4de78a4449480e045e5a
Publikováno v:
PLoS Medicine, Vol 9, Iss 4, p e1001202 (2012)
Externí odkaz:
https://doaj.org/article/b57ffa14f839440ab774a8982fcd0f3d
Publikováno v:
Journal of Comparative Effectiveness Research. 10:711-731
Decision-makers have become increasingly interested in incorporating real-world evidence (RWE) into their decision-making process. Due to concerns regarding the reliability and quality of RWE, stakeholders have issued numerous recommendation document
Autor:
Jennifer Graff, Nirosha Mahendraratnam Lederer, L. Orsini, Sebastian Schneeweiss, Gregory W. Daniel, Brigitta Monz, John Guerino, Shirley V. Wang, Richard J. Willke, Hans-Georg Eichler, Pall Jonsson, Marc L. Berger, Wim G. Goettsch, David Van Brunt, C. Daniel Mullins, William H. Crown
Publikováno v:
Pharmacoepidemiology and Drug Safety. 29:1504-1513
Real-world data (RWD) and the derivations of these data into real-world evidence (RWE) are rapidly expanding from informing healthcare decisions at the patient and health system level to influencing major health policy decisions, including regulatory
Autor:
Francesca Scotti, Fergus Sweeney, Harald Enzmann, Guido Rasi, Marco Cavaleri, Spiros Vamvakas, Bruno Sepodes, Hans Georg Eichler
Publikováno v:
Clinical Pharmacology and Therapeutics
Clinical Pharmacology & Therapeutics
Clinical Pharmacology & Therapeutics
The scientific community has risen to the coronavirus disease 2019 (COVID-19) challenge, coming up with an impressive list of candidate drugs and vaccines targeting an array of pharmacological and immunological mechanisms. Yet, generating clinical ev
Autor:
Jonathan Lind Martinsson, Peter Arlett, Rick A. Vreman, Martin Wenzl, Inneke van de Vijver, Roisin Adams, Anna Nachtnebel, Lonneke Timmers, Hans-Georg Eichler, Einar Andreassen, Suzannah Chapman, Elias Pean, Tove Ragna Reksten, Guido Rasi, Wim G. Goettsch, Marc Van de Casteele, Jordi Llinares-Garcia
Publikováno v:
International Journal of Technology Assessment in Health Care, 37(1), 1. Cambridge University Press
Performance-based managed entry agreements (PB-MEAs) might allow patient access to new medicines, but practical hurdles make competent authorities for pricing and reimbursement (CAPR) reluctant to implement PB-MEAs. We explored if the feasibility of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3b4f7d48d3f7dd1a95acfc3ddd658259
https://lirias.kuleuven.be/handle/123456789/679492
https://lirias.kuleuven.be/handle/123456789/679492
Autor:
Kenneth A. Oye, Kenneth I. Kaitin, Newell E. McElwee, Heather C. Kaplan, Ralph B. D'Agostino, Richard L. Kravitz, Kay Larholt, Hans Georg Eichler, Willard H. Dere, Chandra Ramanathan, S. Nassir Ghaemi, Mark R. Trusheim, Eleanor M. Perfetto, Vicki L. Seyfert-Margolis, Marisha E. Palm, Theodora Cohen, Christopher H. Schmid, Peter Honig, Harry P. Selker
Publikováno v:
Clinical pharmacology and therapeutics. 112(2)
Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic c
Autor:
Newell E. McElwee, Peter K. Honig, Norman Stockbridge, Harry P. Selker, Hans-Georg Eichler, Kenneth I. Kaitin, Theodora Cohen, John K. Erban, Vicki L. Seyfert-Margolis, Willard H. Dere, Kenneth A. Oye, Ralph B. D'Agostino
Publikováno v:
Clinical Pharmacology and Therapeutics
Efficacy trials, designed to gain regulatory marketing approval, evaluate drugs in optimally selected patients under advantageous conditions for relatively short time periods. Effectiveness trials, designed to evaluate use in usual practice, assess t
Autor:
Nick Crabb, Gigi Hirsch, Robyn Lim, Pierre Sabourin, Naomi Aronson, Linda Wilhelm, Murray Lumpkin, David K Lee, Louise Binder, Brian O'Rourke, Hans-Georg Eichler, Marilyn Metcalf, Anja Schiel, Inhua Muijrers Chen, Solange Corriol-Rohou, John Ferguson, Meredith Smith, Marc Boutin, E Pezalla
Publikováno v:
Clinical Pharmacology and Therapeutics
Therapeutic product development, licensing and reimbursement may seem a well‐oiled machine, but continuing high attrition rates, regulatory refusals, and patients’ access issues suggest otherwise; despite serious efforts, gaps persist between sta