Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Thomas Hoffelder"'
Autor:
Andreas M. Abend, Thomas Hoffelder, Michael J. Cohen, Leslie Van Alstine, Dorys Argelia Diaz, Emilija Fredro-Kumbaradzi, James Reynolds, Yanbing Zheng, Krista Witkowski, Tycho Heimbach
Publikováno v:
The AAPS Journal. 25
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
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
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
Autor:
Andreas Abend, Poonam Delvadia, David Leblond, Thomas Hoffelder, Elisabeth Kovacs, Sandra Suarez-Sharp, Dorys Argelia Diaz
Publikováno v:
The AAPS Journal. 22
The pharmaceutical industry and regulatory agencies rely on dissolution similarity testing to make critical product performance decisions as part of drug product life cycle management. Accordingly, the application of mathematical approaches to evalua
Autor:
Thomas Hoffelder
Publikováno v:
Biometrical Journal. 61:1120-1137
For some postapproval changes, the manufacturer has to demonstrate that the dissolution profile of the drug product before the change is statistically equivalent to the dissolution profile after the change. Guidelines suggest the so-called similarity
Autor:
Keyur Joshi, Elise Burmeister Getz, David Christopher, Thomas Hoffelder, Marisa Pertile, Svetlana Lyapustina, Monisha Dey, Beth Morgan, Stephen Andrews, Hayden Beresford, David Wilcox, Göran Långström, Helen Strickland, Mark R. Berry, Christopher Wiggenhorn, Stephanie T. Chen, Daniela Acerbi, Mary McKenry
Publikováno v:
AAPS PharmSciTech. 19:1410-1425
This article reports performance characteristics of the population bioequivalence (PBE) statistical test recommended by the US Food and Drug Administration (FDA) for orally inhaled products. A PBE Working Group of the International Pharmaceutical Aer
Autor:
Thomas Hoffelder
Publikováno v:
Biometrical Journal. 61:1138-1140
Autor:
Thomas Hoffelder
Publikováno v:
Therapeutic innovationregulatory science. 52(4)
Dissolution profile comparisons are used in the context of postapproval changes where the manufacturer has to demonstrate that the quality of the product is not affected by the change. Around this topic, basic statistical principles are in conflict w
Publikováno v:
Journal of biopharmaceutical statistics. 25(3)
Statistical equivalence analyses are well-established parts of many studies in the biomedical sciences. Also in pharmaceutical development and manufacturing equivalence testing methods are required in order to statistically establish similarities bet