Zobrazeno 1 - 10
of 18
pro vyhledávání: '"Ana Hidalgo-Simon"'
Publikováno v:
Molecular Frontiers Journal, Vol 05, Iss 01n02, Pp 58-65 (2021)
The current COVID-19 pandemic has had a vertiginous accelerating effect on the time from identification of a new virus to a vaccine being deployed. A key step in this journey, the marketing authorization process, is under intense scrutiny and time pr
Externí odkaz:
https://doaj.org/article/40b39ee395824da9bc85f3cac09b9e0a
Autor:
Ana Hidalgo-Simon
Publikováno v:
Molecular Frontiers Journal, Vol 3, Iss 2, Pp 138-146 (2019)
Gene editing and other laboratory developments promise to revolutionize treatment of many diseases that currently have no cure. The process to become a medicine is long and complex and requires many years. Regulation of medicines (permission to marke
Externí odkaz:
https://doaj.org/article/c4cb467c1fa74f6aa94f2bf1007ad674
Publikováno v:
Molecular Frontiers Journal. :58-65
The current COVID-19 pandemic has had a vertiginous accelerating effect on the time from identification of a new virus to a vaccine being deployed. A key step in this journey, the marketing authorization process, is under intense scrutiny and time pr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::566233d9f8b4b81ef9ff3cfa1d73230d
https://doi.org/10.1142/s2529732521400034
https://doi.org/10.1142/s2529732521400034
Publikováno v:
British Journal of Clinical Pharmacology. 87:2450-2458
Gene therapy medicinal products have the potential to provide curative treatment for many diseases with current limited therapeutic options. As advanced therapy medicinal products (ATMPs), these therapies undergo a centralised, single European Union
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b19e7942d275470823786f4b9912627
https://doi.org/10.1111/bcp.14781
https://doi.org/10.1111/bcp.14781
Publikováno v:
British Journal of Clinical Pharmacology
Scientific advice (SA) is an important tool offered by regulators to help developers generate robust evidence on a medicine's benefits and risks. Drawing on accumulated experience and looking at the SA provided by the European Medicines Agency in 201
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::205e870754223083d856c87bc01ffd90
https://doi.org/10.1111/bcp.14672
https://doi.org/10.1111/bcp.14672
Publikováno v:
Clinical Pharmacology and Therapeutics
Clinical Pharmacology & Therapeutics, 105(4), 962-969. Wiley-Blackwell
Clinical Pharmacology & Therapeutics, 105(4), 962-969. Wiley-Blackwell
Biologicals are established treatment options that require pharmacovigilance adapted to their specific nature, including the need for products to be identifiable up to the specific manufacturer in reports of adverse drug reactions (ADRs). This study
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::52ff247e4e6b53e0240b7754a09a3729
https://doi.org/10.1002/cpt.1310
https://doi.org/10.1002/cpt.1310
Autor:
Andrea Laslop, Thijs J Giezen, Martina Weise, Elena Wolff-Holz, Luis Pinheiro, Ana Hidalgo-Simon
Publikováno v:
Clinical pharmacology & therapeutics, 110(5):1311-1317
The relevance of biological therapies for an increasing number of conditions is on the rise. Following the expiry of the initial period of market exclusivity, many of these successful therapies have seen the arrival of biosimilars on the market. The
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9c40ae4f613e17cc4d5c846c8c4bade6
https://pubmed.ncbi.nlm.nih.gov/34472087
https://pubmed.ncbi.nlm.nih.gov/34472087
Autor:
Willem E. Fibbe, Ana Hidalgo-Simon
Publikováno v:
British journal of clinical pharmacologyREFERENCES. 87(6)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::be91cde9e49895f53e9e9f329c843170
https://pubmed.ncbi.nlm.nih.gov/34528281
https://pubmed.ncbi.nlm.nih.gov/34528281
Autor:
Irmgard Eichler, Brigitte Schwarzer-Daum, Spiros Vamvakas, Anthony J. Humphreys, Nikolai Constantin Brun, Francesco Pignatti, Ana Hidalgo-Simon, Hans-Georg Eichler, Peter Arlett, Guido Rasi
Publikováno v:
Clinical Pharmacology and Therapeutics
Compared with drugs from the blockbuster era, recently authorized drugs and those expected in the future present a heterogenous mix of chemicals, biologicals, and cell and gene therapies, a sizable fraction being for rare diseases, and even individua
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::157e53c0ac087c746cdfa83e032d30c8
http://hdl.handle.net/2108/294345
http://hdl.handle.net/2108/294345
Publikováno v:
Nature reviews. Nephrology. 16(10)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::9bd8b4cec1ffcd419782e1d5c845401f
https://pubmed.ncbi.nlm.nih.gov/32242124
https://pubmed.ncbi.nlm.nih.gov/32242124