Zobrazeno 1 - 10
of 22
pro vyhledávání: '"Yu Chung Tsang"'
Autor:
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 624-630 (2023)
Abstract On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrat
Externí odkaz:
https://doaj.org/article/7ba25868225a4671a0706b3a2c4392e8
Autor:
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong‐Jin Kim, Jianghong Fan, Banu S. Zolnik, Duxin Sun, Yi Zhang, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 585-597 (2023)
Abstract This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the
Externí odkaz:
https://doaj.org/article/bff355b182e94d38a6b888911c0d4a2e
Autor:
Sherif M. Badawy, Antonis Kattamis, Hatoon Ezzat, Benoît Deschamps, Eric Sicard, Caroline Fradette, Feng Zhao, Fernando Tricta, Yu Chung Tsang, Sujit Sheth, Antonio Piga
Publikováno v:
British Journal of Haematology. 197
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e6b02b7619f30b7a6413098fbb2261c2
https://doi.org/10.1111/bjh.17999
https://doi.org/10.1111/bjh.17999
Autor:
Denis Soulières, Jules Mercier-Ross, Caroline Fradette, Anna Rozova, Yu Chung Tsang, Fernando Tricta
Publikováno v:
Annals of hematology. 101(3)
Patients with sickle cell disease (SCD) who undergo repeated blood transfusions often develop iron overload. Deferiprone (Ferriprox®) is an oral iron chelator indicated for the treatment of transfusional iron overload due to thalassemia syndromes an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ce22ac2af115e9817fc431d737ca035d
https://pubmed.ncbi.nlm.nih.gov/34981144
https://pubmed.ncbi.nlm.nih.gov/34981144
Autor:
Oscar Della Pasqua, Laila M. Sherief, Amal El-Beshlawy, Paul Telfer, Adriana Ceci, Liana Cuccia, Bianca Tempesta, Donato Bonifazi, Hoda Hassab, Mohamed Bejaoui, Yu Chung Tsang, Carlo Cosmi, Giovanni Carlo Del Vecchio, Antonis Kattamis, Soteroula Christou, Angela Vitrano, Giorgio Reggiardo, Ariana Zaka, Manika Kreka, Raffaella Origa, Aldo Filosa, Mariagrazia Felisi, Fernando Tricta, Aurelio Maggio, Michael Spino, Maria Caterina Putti
Publikováno v:
The Lancet. Haematology. 7(6)
Transfusion-dependent haemoglobinopathies require lifelong iron chelation therapy with one of the three iron chelators (deferiprone, deferasirox, or deferoxamine). Deferasirox and deferiprone are the only two oral chelators used in adult patients wit
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cd6e861631878c693e566404a94c323d
https://pubmed.ncbi.nlm.nih.gov/32470430
https://pubmed.ncbi.nlm.nih.gov/32470430
Autor:
Yu Chung Tsang, Gerald Beuerle, Henning Blume, Mehul Mehta, Jan Welink, Mei-Ling Chen, Ralph-Steven Wedemeyer, Barbara M. Davit, Henrike Potthast, Werner Weitschies, Barbara Schug
Publikováno v:
European Journal of Pharmaceutical Sciences. 111:153-157
Bioequivalence (BE) is considered one of the key questions in new and generic drug product development and registration worldwide. However, the regulations and jurisdiction vary from country to country and continent to continent. Harmonization of reg
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6132f5459b7ab5e2d8faf16eca9c7be0
https://doi.org/10.1016/j.ejps.2017.09.047
https://doi.org/10.1016/j.ejps.2017.09.047
Autor:
Yu Chung Tsang, Anne Stilman, Anna Rozova, Caroline Fradette, Mark J. Allison, Fernando Tricta
Publikováno v:
Clinical Pharmacology in Drug Development. 7:22-32
This study evaluated whether deferiprone, an oral iron chelator, acts to prolong the QT interval. Fifty healthy volunteers received single doses of each of the following: therapeutic dose of deferiprone (33 mg/kg), supratherapeutic dose (50 mg/kg), p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::29a9e09f41af769f72e1aa75a38b175b
https://doi.org/10.1002/cpdd.352
https://doi.org/10.1002/cpdd.352
Autor:
Fernando Tricta, Shalini Jayashankar, Yu Chung Tsang, Vincent Pichette, Eric Sicard, Caroline Fradette, Anne Stilman, Michael Spino
Publikováno v:
British Journal of Clinical Pharmacology
Aims In light of the growing recognition of renal disease in thalassemia, it is important to understand the impact of renal impairment on the pharmacokinetics of iron chelators. This study evaluated the pharmacokinetics and safety of the iron chelato
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7c184f0ee47922ce2bf6d404e68ef8e5
https://doi.org/10.1111/bcp.13037
https://doi.org/10.1111/bcp.13037
Publikováno v:
The AAPS Journal. 18:612-618
The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the firs
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3bab863d6f0b7d4af6b1b83e968ff39
https://doi.org/10.1208/s12248-016-9877-2
https://doi.org/10.1208/s12248-016-9877-2
Publikováno v:
Clinical pharmacology and therapeutics. 105(2)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3d9cb9426e035b6546f4e10869ed50cc
https://pubmed.ncbi.nlm.nih.gov/30456787
https://pubmed.ncbi.nlm.nih.gov/30456787