Zobrazeno 1 - 9
of 9
pro vyhledávání: '"Evangelos Kotzagiorgis"'
Autor:
Efthymios Manolis, Alfredo García‐Arieta, Anders Lindahl, Evangelos Kotzagiorgis, Jobst Limberg, Øyvind Holte, Paulo Paixao, Carolien Versantvoort, Flora Musuamba Tshinanu, Kevin Blake, Michiel Van Den Heuvel
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 556-559 (2023)
Externí odkaz:
https://doaj.org/article/a77d355ba57d45bbaaac7700cf82f8a7
Autor:
Mark McAllister, Talia Flanagan, Susan Cole, Andreas Abend, Evangelos Kotzagiorgis, Jobst Limberg, Heather Mead, Victor Mangas-Sanjuan, Paul A. Dickinson, Andrea Moir, Xavier Pepin, Diansong Zhou, Christophe Tistaert, Aristides Dokoumetzidis, Om Anand, Maxime Le Merdy, David B. Turner, Brendan T. Griffin, Adam Darwich, Jennifer Dressman, Claire Mackie
Publikováno v:
Pharmaceutics, Vol 14, Iss 5, p 1010 (2022)
A webinar series that was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics focus group in 2021 focused on the challenges of developing clinically relevant dissolution specifications (CRDSs) for oral drug products. Industrial scien
Externí odkaz:
https://doaj.org/article/ef6f2c994c1b4a04809bf2645feb40a0
Autor:
Mark McAllister, Talia Flanagan, Karin Boon, Xavier Pepin, Christophe Tistaert, Masoud Jamei, Andreas Abend, Evangelos Kotzagiorgis, Claire Mackie
Publikováno v:
Pharmaceutics, Vol 12, Iss 1, p 19 (2019)
A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products. Industr
Externí odkaz:
https://doaj.org/article/d563840c12884c1e841c153027ac2f11
Autor:
Evangelos Kotzagiorgis, Shinichi Kijima, Om Anand, Yang Zhao, Sandra Suarez-Sharp, Talia Flanagan, Min Li, Baoming Ning, Poonam Delvadia, Shefali Kakar, Amitava Mitra, Greg Rullo, Jennifer B. Dressman, Neil Parrott, Erik Sjögren, Banu S. Zolnik, Shereeni Veerasingham, Paul A. Dickinson, Gustavo Mendes Lima Santos, Tycho Heimbach, Haritha Mandula, Christophe Tistaert, Fang Wu, Kimberly Raines, Satish Sharan, Xavier Pepin, Andrew Babiskin
Publikováno v:
Journal of Pharmaceutical Sciences. 110:594-609
This report summarizes the proceedings for Day 3 of the workshop titled "Current State and Future Expectations of Translational Modeling Strategies toSupportDrug Product Development, Manufacturing Changes and Controls". From a drug product quality pe
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fd0af49b3fa2be786e937037a5062f10
https://doi.org/10.1016/j.xphs.2020.10.059
https://doi.org/10.1016/j.xphs.2020.10.059
Autor:
Andreas M, Abend, Limin, Zhang, Emilija, Fredro-Kumbaradzi, Thomas, Hoffelder, Michael J, Cohen, Om, Anand, Poonam, Delvadia, Haritha, Mandula, Zhen, Zhang, Evangelos, Kotzagiorgis, Susan, Lum, Victor Gomes, Pereira, Amy, Barker, David, Lavrich, Johannes, Kraemer, Sandra, Sharp-Suarez
Publikováno v:
The AAPS Journal. 24
This report summarizes podium presentations and breakout sessions from the second day of the 2019 M-CERSI workshop on In Vitro Dissolution Similarity Assessment in Support of Drug Product Quality: What, How, and When? Presenters from the U.S. Food an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9037391d8f0d4c162e0e0e2393bc7978
https://doi.org/10.1208/s12248-022-00691-4
https://doi.org/10.1208/s12248-022-00691-4
Autor:
Evangelos Kotzagiorgis, Kathrin Moellenhoff, Stanislas Volgushev, Holger Dette, Olivier Collignon
Publikováno v:
Statistics in Medicine. 37:2968-2981
In drug development, comparability of dissolution profiles of 2 different formulations is usually assessed using the similarity factor f2 . In practice, the drug dissolution profiles are deemed similar if the f2 exceeds 50, which occurs when a 10% ma
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4b2d754093fd25e68a041c7d44c5caf7
https://doi.org/10.1002/sim.7689
https://doi.org/10.1002/sim.7689
Autor:
Xavier Pepin, Mark McAllister, Masoud Jamei, Talia Flanagan, Andreas Abend, Christophe Tistaert, Claire Mackie, Evangelos Kotzagiorgis, Karin Boon
Publikováno v:
Pharmaceutics
Pharmaceutics, Vol 12, Iss 1, p 19 (2019)
Pharmaceutics, Vol 12, Iss 1, p 19 (2019)
A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products. Industr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e9bb01d55c4174848328c6fa52c0cb1f
https://doi.org/10.3390/pharmaceutics12010019
https://doi.org/10.3390/pharmaceutics12010019
Autor:
Shinichi Kijima, Filippos Kesisoglou, Kimberly Raines, Andreas Abend, Xinyuan Zhang, Paul Seo, Poonam Delvadia, Nagesh Bandi, Min Li, Evangelos Kotzagiorgis, Sandra Suarez-Sharp, Erik Sjögren, Tycho Heimbach, Anna Nordmark, Andrew Babiskin, Patrick J. Marroum, Michael J. Cohen, Haritha Mandula
Publikováno v:
The AAPS journal. 20(6)
This publication summarizes the proceedings of day 3 of a 3-day workshop on "Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development." Specifically, this publication discusses the current approaches in building
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b084be6477a3b7ae921931825751e1da
https://pubmed.ncbi.nlm.nih.gov/30151612
https://pubmed.ncbi.nlm.nih.gov/30151612
Autor:
Kathrin, Moellenhoff, Holger, Dette, Evangelos, Kotzagiorgis, Stanislas, Volgushev, Olivier, Collignon
Publikováno v:
Statistics in medicine. 37(20)
In drug development, comparability of dissolution profiles of 2 different formulations is usually assessed using the similarity factor f
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::f74cd6aea0498dbd0f213891bd02a5db
https://pubmed.ncbi.nlm.nih.gov/29862526
https://pubmed.ncbi.nlm.nih.gov/29862526