Zobrazeno 1 - 10
of 14
pro vyhledávání: '"Alex Zwiers"'
Publikováno v:
Clinical and Translational Science, Vol 16, Iss 7, Pp 1127-1133 (2023)
Abstract The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization: (i)
Externí odkaz:
https://doaj.org/article/b7f3aff2d8774f06872d65ca0ba27b06
Publikováno v:
Clinical and Translational Science, Vol 15, Iss 8, Pp 1959-1967 (2022)
Abstract The aim of this study was to assess the effect of expedited regulatory approval programs used by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), type of product (small molecule or biotechnology‐derived pr
Externí odkaz:
https://doaj.org/article/9d0501144a0342daabaf2ee46ed86634
Publikováno v:
Thrombosis research, 227, 17-24. Elsevier Limited
Background: Antithrombotic therapy is inevitably associated with a risk for bleeding and these bleeding complications can be life-threatening. Recently, specific reversal agents were developed for the direct factor Xa and thrombin inhibitors (DOACs).
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5ffea284dc0559bc58d6ec11c2bacdf0
https://doi.org/10.1016/j.thromres.2023.05.003
https://doi.org/10.1016/j.thromres.2023.05.003
Publikováno v:
Clinical and Translational Science.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8b501e79da0f2bbb73360c323ed579d8
https://doi.org/10.1111/cts.13519
https://doi.org/10.1111/cts.13519
Publikováno v:
Therapeutic Innovation & Regulatory Science
Background Cancer is a serious global health problem and a major cause of death. The European Medicines Agency (EMA) has established several regulatory initiatives to expedite the development and authorization of drugs to ensure timely access of pati
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d247d3b2f02386fdb5219af293b7dd59
https://doi.org/10.1007/s43441-021-00260-5
https://doi.org/10.1007/s43441-021-00260-5
Publikováno v:
Therapeutic Innovation & Regulatory Science
Background Quality by Design (QbD) is a systematic risk-based approach to development, with predefined characteristics and quality risk management throughout the life cycle of a product. International Conference on Harmonization (ICH) guidelines Q8
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::421fec2b85704858eda38b3d96a694ce
http://europepmc.org/articles/PMC8021511
http://europepmc.org/articles/PMC8021511
Publikováno v:
Therapeutic Innovation & Regulatory Science
Background Recent scientific advances in cancer research have led to the development of immunomodulatory and molecularly targeted drugs with better safety profiles than chemotherapeutics, which makes it possible to include healthy volunteers (HVs) in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::db3774eb7ac9a84989643b1cde5007bf
https://pubmed.ncbi.nlm.nih.gov/34379306
https://pubmed.ncbi.nlm.nih.gov/34379306
Autor:
Steven Ramael, Alex Zwiers, Pieter-Jan de Kam, Jean-Luc Jadoul, Pierre A.M. Peeters, Michiel W. van den Heuvel, Erik de Clerck, Peter Grobara
Publikováno v:
Clinical drug investigation. 32(3)
Background: Sugammadex, a modified γ-cyclodextrin, facilitates rapid reversal of rocuronium- and vecuronium-induced neuromuscular blockade (NMB). Cyclodextrins are known for their ability to form inclusion complexes with various drugs. Theoretically
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::341cdec2463d209b94ce7bd0db147a6d
https://pubmed.ncbi.nlm.nih.gov/22201295
https://pubmed.ncbi.nlm.nih.gov/22201295
Autor:
Michiel W. van den Heuvel, Pierre A. M. Peeters, Alex Zwiers, Thijs van Iersel, Paul C. C. M. Passier, Emiel van Heumen, Jean Smeets
Publikováno v:
Clinical drug investigation. 30(12)
Sugammadex facilitates rapid reversal of rocuronium- and vecuronium-induced neuromuscular blockade. This study aimed to evaluate the safety, tolerability and pharmacokinetics of high doses of sugammadex (up to 96 mg/kg) in healthy subjects.In this ra
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2f87f8b03f2c05a45653e95cc05ddd1f
https://pubmed.ncbi.nlm.nih.gov/20825252
https://pubmed.ncbi.nlm.nih.gov/20825252
Autor:
Sjoerd van Marle, Pierre Peeters, Alex Zwiers, Marcel de Zwart, Marlou van Iersel, Saskia van de Wetering-Krebbers, Jean Smeets, Paul C. C. M. Passier, Diels van den Dobbelsteen
Publikováno v:
Biopharmaceuticsdrug disposition. 32(3)
Sugammadex is a modified γ-cyclodextrin which rapidly reverses rocuronium-and vecuronium-induced neuromuscular blockade. Previous studies suggest that sugammadex is mostly excreted unchanged via the kidneys. This single-center, open-label, non-rando
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3de86c610c2ab361097a3ce8d0261784
https://pubmed.ncbi.nlm.nih.gov/21370235
https://pubmed.ncbi.nlm.nih.gov/21370235