Zobrazeno 1 - 10
of 66
pro vyhledávání: '"Lucinda F. Buhse"'
Autor:
Johannes Kraemer, Amy R. Barker, Christos Reppas, Kumiko Sakai-Kato, Lucinda F. Buhse, Susanne Keitel, Mary P. Stickelmeyer, Cynthia K. Brown, Horst Dieter Friedel, David C. Sperry, Vinod P. Shah, John Michael Morris
Publikováno v:
Journal of Pharmaceutical Sciences. 107:2995-3002
Dissolution testing is an important physiochemical test for the development of solid oral dosage forms, tablets, and capsules. As a quality control test, the dissolution test is used for assessment of drug product quality and is specified for batch r
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::38ae055b19309313bf1e753f02c834bd
https://doi.org/10.1016/j.xphs.2018.08.007
https://doi.org/10.1016/j.xphs.2018.08.007
Autor:
Adam C. Fisher, Steven Kozlowski, Michael Kopcha, Sau L. Lee, Lawrence X. Yu, Lucinda F. Buhse, Janet Woodcock, Daniel P. Harris
Publikováno v:
International Journal of Pharmaceutics. 515:390-402
Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1647a8bc8e79daea910afc7ac4d48783
https://doi.org/10.1016/j.ijpharm.2016.10.038
https://doi.org/10.1016/j.ijpharm.2016.10.038
Autor:
Michael Kopcha, Lucinda F. Buhse, Adam C. Fisher, Janet Woodcock, Richard L. Friedman, Melika Ashtiani, Alex Viehmann
Publikováno v:
JAMA Network Open
Key Points Question Are there substantive differences in the major quality attributes of difficult-to-make pharmaceutical products manufactured throughout the world and marketed in the US? Findings In this quality improvement study, all of 252 drug p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::38244f2a1c382b2db7ac604240e76507
https://doi.org/10.1001/jamanetworkopen.2020.13920
https://doi.org/10.1001/jamanetworkopen.2020.13920
Autor:
Caroline Strasinger, Bing Cai, Jennifer Kessler, Andre Raw, Anna M. Wokovich, Moo Jhong Rhee, Lucinda F. Buhse, Benjamin J. Westenberger
Publikováno v:
International Journal of Adhesion and Adhesives. 59:71-76
Cold flow, the movement of adhesive beyond the edge of a transdermal drug delivery system (TDDS) or between the release liner slit, can affect the quality of the drug product and result in patient use issues such as difficulty in removal from packagi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0bf77aa32f740b7e34f50d18283369d6
https://doi.org/10.1016/j.ijadhadh.2015.02.002
https://doi.org/10.1016/j.ijadhadh.2015.02.002
Autor:
John F. Kauffman, Lydia Velazquez, Stephanie Clark, B. Bishop, Zongming Gao, Benjamin J. Westenberger, Lawrence X. Yu, Terry Moore, Mike Trehy, Scott Furness, Lucinda F. Buhse
Publikováno v:
AAPS PharmSciTech. 16:1227-1233
Over-the-counter (OTC) drug products are medicines that can be sold directly to a consumer without a prescription from a health-care practitioner. OTC drugs generally have these characteristics which have been summarized on FDA’s website “1) thei
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f44946ad6ad06e202ab8cc18195db1ec
https://doi.org/10.1208/s12249-015-0297-x
https://doi.org/10.1208/s12249-015-0297-x
Autor:
Jamie D. Dunn, Lucinda F. Buhse, Daniel J. Mans, Houman Ghasriani, Dianna Long, John F. Kauffman, Richard E. Kolinski, Hongping Ye, David A. Keire, Nisarga L. Phatak
Publikováno v:
Analytical Biochemistry. 490:52-54
N-sulfonated oversulfated chondroitin sulfate (NS-OSCS), recently reported as a potential threat to the heparin supply, was prepared along with its intermediate derivatives. All compounds were spiked into marketplace heparin and subjected to United S
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d17f9dc389f2bc945902b0a52874c318
https://doi.org/10.1016/j.ab.2015.08.003
https://doi.org/10.1016/j.ab.2015.08.003
Autor:
Timothy K. Toby, Ali Al-Hakim, Hongping Ye, Houman Ghasriani, David A. Keire, Richard E. Kolinski, Cynthia D. Sommers, Wei Ye, Michael L. Trehy, Lucinda F. Buhse
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 85:99-107
During the 2007-2008 heparin crisis it was found that the United States Pharmacopeia (USP) testing monograph for heparin sodium or low molecular weight heparins did not detect the presence of the contaminant, oversulfated chondroitin sulfate (OSCS).
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fbad72ba54f38f230be0c60a225f39db
https://doi.org/10.1016/j.jpba.2013.06.033
https://doi.org/10.1016/j.jpba.2013.06.033
Publikováno v:
Analytical Chemistry. 85:1531-1539
The application of multiplexed isobaric tandem mass tag (TMT) labeling and an LTQ Orbitrap XL ETD (electron transfer dissociation) hybrid mass spectrometer as a direct approach for qualitative and quantitative characterization of glycoproteins is rep
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5483958e19e112569362d7c36cf2501d
https://doi.org/10.1021/ac3026465
https://doi.org/10.1021/ac3026465
Autor:
David A. Keire, Steven Kozlowski, John P. Marino, Robert G. Brinson, Derek J. Hodgson, Ian McEwen, Lucinda F. Buhse, Yves Aubin, Houman Ghasriani
Publikováno v:
Nature biotechnology. 34(2)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::32d07f01530f18ba5c69e7fb14d7ba51
https://pubmed.ncbi.nlm.nih.gov/26849514
https://pubmed.ncbi.nlm.nih.gov/26849514
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. :42-50
Previously, the FDA validated a method to assess the structure and composition of heparin products by separating and quantifying disaccharide level digests by reverse-phase-ion-pairing liquid chromatography (RPIP-HPLC) coupled to a low resolution and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b8fc2d731419cd7f035b5faa1ab2b8b
https://doi.org/10.1016/j.jpba.2012.04.033
https://doi.org/10.1016/j.jpba.2012.04.033