Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Mark R. Berry"'
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:
Venkat Koganti, Mark R. Berry, Maickel Youssef, Sumit Luthra, Thomas Osterberg, Gillian Fitzpatrick, Liling Zhang, Martin Nolan, Niall Fitzgibbon, Rosemary Barrett, Gioval Scalzo, Evgenyi Shalaev, David Hiebert, Frank A. Kanka
Publikováno v:
AAPS PharmSciTech. 12:854-861
In this work, we explore the idea of using mathematical models to build design space for the primary drying portion of freeze-drying process. We start by defining design space for freeze-drying, followed by defining critical quality attributes and cr
Autor:
Mark R. Berry, M. D. Likar
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 45:194-200
A general multivariate procedure for assessing the similarity of dissolution and drug release profiles was developed. A mathematical model is fit to the data, and Hotelling's T(2) test is used to calculate the joint confidence region around the vecto
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 44:1064-1071
A dissolution method with high performance liquid chromatography (HPLC) analysis was validated for an immediate release low dose tablet formulation. The method was validated to meet requirements for a global regulatory filing and this validation incl
Autor:
Timothy L. Houck, Beverly Nickerson, Hany L. Mansour, William B. Arikpo, Vincent J. Bobin, Mark R. Berry, John Warzeka
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 47(2)
Several sample preparation techniques were evaluated for extracting active pharmaceutical ingredient (API) from immediate release (IR) and controlled release (CR) tablet formulations. These techniques utilized either elevated temperature [e.g., accel
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 44(1)
During development of solid dosage products, a pharmaceutical manufacturer is typically required to propose dissolution acceptance criteria unless the product falls into Biopharmaceutics Classification System (BCS) class I, in which case a disintegra