Zobrazeno 1 - 10
of 23
pro vyhledávání: '"Sandra Suarez‐Sharp"'
Autor:
Xavier J. H. Pepin, Scott M. Hynes, Hamim Zahir, Deborah Walker, Lois Q. Semmens, Sandra Suarez‐Sharp
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 10, Pp 1771-1783 (2024)
Abstract Omaveloxolone is a nuclear factor (erythroid‐derived 2)‐like 2 activator approved in the United States and the European Union for the treatment of patients with Friedreich ataxia aged ≥16 years, with a recommended dosage of 150 mg oral
Externí odkaz:
https://doaj.org/article/d460f6850b8b4da5a5d2f5e21b780d1f
Autor:
Nikolay Zaborenko, Tessa M. Carducci, Alexander Ryckaert, Haritha Mandula, Matthew J. Walworth, Casey J. Smith, Sandra Suarez-Sharp, Melanie Dumarey, Sara Manteiga, Sarah Nielsen, Stan Altan, Adriene Malsbury, Beverly Nickerson, Yanmei Lan
Publikováno v:
Dissolution Technologies. 29:150-172
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8b647dc48857f621b49515bc6919c0e9
https://doi.org/10.14227/dt290322p150
https://doi.org/10.14227/dt290322p150
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:
Erik Sjögren, James Butler, Vidula Kolhatkar, Xavier Pepin, Lynne S. Taylor, Andrew Babiskin, Sandra Suarez-Sharp, Paul Seo, Jennifer B. Dressman, Christer Tannergren, André Dallmann, Xinyuan Zhang, Poonam Delvadia, Edmund Kostewicz, Yang Zhao, Amitava Mitra, Filippos Kesisoglou, Mirko Koziolek, Neil Parrott
Publikováno v:
Journal of Pharmaceutical Sciences. 110:567-583
This workshop report summarizes the proceedings of Day 1 of a three-day workshop on “Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls”. Physiologica
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c4d0f759414a16121ec56c04e1405fb4
https://doi.org/10.1016/j.xphs.2020.09.021
https://doi.org/10.1016/j.xphs.2020.09.021
Autor:
Thomas Hoffelder, David Leblond, Leslie Van Alstine, Dorys Argelia Diaz, Sandra Suarez-Sharp, Krista Witkowski, Stan Altan, James Reynolds, Zachary Bergeron, Kevin Lief, Yanbing Zheng, Andreas Abend
Publikováno v:
The AAPS Journal. 24
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ce9d700b82ee644573616c454b6c40d5
https://doi.org/10.1208/s12248-022-00697-y
https://doi.org/10.1208/s12248-022-00697-y
Autor:
Samir Haddouchi, Diane J. Burgess, Xujin Lu, Sandra Suarez Sharp, Nikoletta Fotaki, Baoming Ning
Publikováno v:
Dissolution Technologies. 27:42-50
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9f975bcf8c4727f1e762e196814108c6
https://doi.org/10.14227/dt270220p42
https://doi.org/10.14227/dt270220p42
Autor:
Thomas, Hoffelder, David, Leblond, Leslie, Van Alstine, Dorys Argelia, Diaz, Sandra, Suarez-Sharp, Krista, Witkowski, Stan, Altan, James, Reynolds, Zachary, Bergeron, Kevin, Lief, Yanbing, Zheng, Andreas, Abend
Publikováno v:
The AAPS journal. 24(3)
The pharmaceutical industry and regulatory agencies rely on dissolution similarity testing to make critical product decisions as part of drug product life cycle management. Accordingly, the application of mathematical approaches to evaluate dissoluti
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::5a969d37284010ad39a8f0b64764369a
https://pubmed.ncbi.nlm.nih.gov/35386051
https://pubmed.ncbi.nlm.nih.gov/35386051
Publikováno v:
Journal of pharmaceutical sciences. 111(1)
Highly variable disposition after oral ingestion of acyclovir has been reported, although little is known regarding the underlying mechanisms. Different studies using the same reference product (Zovirax ®) showed that Cmax and AUC were respectively
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8e25237522c7c8ec1225a915e3db0aaf
https://pubmed.ncbi.nlm.nih.gov/34678271
https://pubmed.ncbi.nlm.nih.gov/34678271
Autor:
Sivacharan Kollipara, Sandra Suarez-Sharp, Martin Mueller-Zsigmondy, Christophe Tistaert, Tausif Ahmed, Amitava Mitra, Jasmina Novakovic, Tycho Heimbach, Filippos Kesisoglou
Publikováno v:
Journal of pharmaceutical sciences. 110(12)
For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption. In the context of drug product quality, safe space is defined as the boundaries of in vitro dissolution, and relevant quality attributes, w
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::14a44f2d3088c14c32fc7236e2ec9a80
https://pubmed.ncbi.nlm.nih.gov/34551349
https://pubmed.ncbi.nlm.nih.gov/34551349
Autor:
Sandra Suarez-Sharp, Jennifer B. Dressman, Poonam Delvadia, Vidula Kolhatkar, Xavier Pepin, Andrew Babiskin, Amitava Mitra, Neil Parrott, Xinyuan Zhang
The implementation of clinically relevant drug product specifications (CRDPS) depends on establishing a link between in vitro performance and in vivo exposure. The scientific community, including regulatory agencies, relies on biopharmaceutics tools
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::112d08fbf3f786d33df30ddc852a9d71
https://publica.fraunhofer.de/handle/publica/264399
https://publica.fraunhofer.de/handle/publica/264399
