Zobrazeno 1 - 10
of 40
pro vyhledávání: '"John P. Gabrielson"'
Autor:
Juan Davagnino, John P. Gabrielson
Publikováno v:
Journal of pharmaceutical sciences. 111(10)
Obtaining an elegant finished pharmaceutical product remains a problem when salt concentration is high, protein concentration is low, and particularly when both conditions are combined. We propose a simple approach to develop a robust lyophilized for
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::288ae697ddc1867cfd4f225376728809
https://pubmed.ncbi.nlm.nih.gov/35777485
https://pubmed.ncbi.nlm.nih.gov/35777485
Publikováno v:
Journal of Pharmaceutical Sciences. 109:2413-2425
A diverse set of analytical tools is required to characterize the complex structural properties of biopharmaceutical products and to ensure their quality, stability, safety, and efficacy. It is generally necessary to demonstrate that such tools are c
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f2d5389f959207883ae0f610b1ba6504
https://doi.org/10.1016/j.xphs.2020.05.012
https://doi.org/10.1016/j.xphs.2020.05.012
Publikováno v:
Journal of Pharmaceutical Sciences. 109:933-936
Protein secondary structures are frequently assessed using infrared and circular dichroism spectroscopies during drug development (e.g., during product comparability and biosimilarity studies, reference standard characterization, etc.) However, there
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d8972d618f8b3e34d9c525b5d33e8765
https://doi.org/10.1016/j.xphs.2019.09.004
https://doi.org/10.1016/j.xphs.2019.09.004
Autor:
John P. Gabrielson, Richard K. Burdick
A “lifecycle approach”, consisting of three stages is used to describe statistical tools that are helpful in the study of a biophysical analytical procedure (method). The focus is on the Stage 2 Procedure Performance Qualification (PPQ) and the w
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1f51f9d5a7392dd273ee2a50583b5e7f
https://doi.org/10.1016/b978-0-444-64173-1.00016-0
https://doi.org/10.1016/b978-0-444-64173-1.00016-0
Autor:
Yves Aubin, Steven A. Berkowitz, George M. Bou-Assaf, Mark L. Brader, Richard K. Burdick, John F. Carpenter, Stephen J. Demarest, Ertan Eryilmaz, Verna Frasca, Darron L. Freedberg, John P. Gabrielson, Andrea Hawe, Damian J. Houde, David A. Keire, Francis Kinderman, Lee Makowski, John P. Marino, Alan G. Marshall, A.J. Miles, John S. Philo, Angelika Reichel, Deniz B. Temel, B.A. Wallace, Daniel Weinbuch, William F. Weiss IV, Sarah Zölls
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8f1ba2bdc0d6cf5768a0331548186954
https://doi.org/10.1016/b978-0-444-64173-1.01002-7
https://doi.org/10.1016/b978-0-444-64173-1.01002-7
Autor:
John P. Gabrielson, William F. Weiss
Biophysical data are routinely collected during development of biopharmaceuticals for a number of purposes ranging from formulation development to process development, elucidation of structure, and product comparability studies. The way in which biop
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::cef3f777b142e919a9bb3b6fc8dc7330
https://doi.org/10.1016/b978-0-444-64173-1.00018-4
https://doi.org/10.1016/b978-0-444-64173-1.00018-4
Autor:
Dan Zhou, Xiaolin Cao, Joseph D. Levine, John P. Gabrielson, Zai-Qing Wen, David Meriage, James A. Loussaert
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 70:62-75
The rapid identification of protein drug products for packaging and receiving can significantly reduce disposition cycle time, and thereby improve the efficiency and productivity of the supply chain to better meet the needs of patients. In this feasi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::97e9a5a0db28d611dcc05c5eb66e1d25
https://doi.org/10.5731/pdajpst.2015.005769
https://doi.org/10.5731/pdajpst.2015.005769
Autor:
John P. Gabrielson, Jared A. Young
Publikováno v:
Biosimilars ISBN: 9783319996790
Guidance from the EMA and FDA suggest a stepwise approach for assessing biosimilarity, an approach that leverages both structural and functional characterization of the biosimilar product to define appropriately-sized non-clinical and clinical studie
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::30f21e197dde8ecfa92bb9314ba250a2
https://doi.org/10.1007/978-3-319-99680-6_13
https://doi.org/10.1007/978-3-319-99680-6_13
Publikováno v:
Biosimilars ISBN: 9783319996790
Availability of biosimilar drugs in the United States and other regions of the world plays an important role in decreasing drug prices and increasing access to life-enhancing therapies. To ensure safety, efficacy, and bioequivalence of these biologic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::fb8a14de2fa230c664cc83c7a2694baf
https://doi.org/10.1007/978-3-319-99680-6_12
https://doi.org/10.1007/978-3-319-99680-6_12
Autor:
John P. Gabrielson, William F. Weiss
Publikováno v:
Journal of Pharmaceutical Sciences. 104:1240-1245
Characterization of the higher order structure (HOS) of biological products has been growing in importance in recent years. Scientists in the biopharmaceutical industry, academic researchers, and regulators are all increasingly aware of the critical
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::252dfc70c13a559f2892ac1d1a8f8ef0
https://doi.org/10.1002/jps.24393
https://doi.org/10.1002/jps.24393