Lucinda F. Buhse

Center for Drug Evaluation and Research — United States

Biochemistry, Genetics and Molecular Biology · Life Sciences

34h-index4.3kcitations74works0.02yr avg
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Research Topics

Proteoglycans and glycosaminoglycans research(17), Drug Solubulity and Delivery Systems(15), Analytical Methods in Pharmaceuticals(13), Spectroscopy and Chemometric Analyses(12), Glycosylation and Glycoproteins Research(10)

Publications74 total

Lessons from CDER’s Quality Management Maturity Pilot Programs
The AAPS Journal·2023· 6 citedOpen Access
Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US
JAMA Network Open·2020· 3 citedOpen Access
FIP Guidelines for Dissolution Testing of Solid Oral Products
Journal of Pharmaceutical Sciences·2018· 56 cited
Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality
International Journal of Pharmaceutics·2016· 77 cited
Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars
Nature Biotechnology·2016· 66 citedOpen Access
Ghasriani NatBiotech Supplemental Feb-2016
2016
Synthesis and detection of N-sulfonated oversulfated chondroitin sulfate in marketplace heparin
Analytical Biochemistry·2015· 8 cited
Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference
The AAPS Journal·2015· 19 citedOpen Access
Dissolution Testing for Bioavailability of Over-the-Counter (OTC) Drugs—a Technical Note
AAPS PharmSciTech·2015· 8 citedOpen Access
Cold flow measurement of transdermal drug delivery systems (TDDS)
International Journal of Adhesion and Adhesives·2015· 12 cited
Rapid screening of anti-infective drug products for counterfeits using Raman spectral library-based correlation methods
The Analyst·2015· 27 cited
Direct Site-Specific Glycoform Identification and Quantitative Comparison of Glycoprotein Therapeutics: Imiglucerase and Velaglucerase Alfa
The AAPS Journal·2014· 9 citedOpen Access
Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms—Workshop Report
Pharmaceutical Research·2014· 21 cited
Characterization of currently marketed heparin products: Key tests for LMWH quality assurance
Journal of Pharmaceutical and Biomedical Analysis·2013· 33 cited
Structural comparison of two anti-CD20 monoclonal antibody drug products using middle-down mass spectrometry
The Analyst·2013· 52 cited
Characterization of currently marketed heparin products: composition analysis by 2D-NMR
Analytical Methods·2013· 39 cited
Direct Approach for Qualitative and Quantitative Characterization of Glycoproteins Using Tandem Mass Tags and an LTQ Orbitrap XL Electron Transfer Dissociation Hybrid Mass Spectrometer
Analytical Chemistry·2012· 53 cited
Qualitative screening for adulterants in weight-loss supplements by ion mobility spectrometry
Journal of Pharmaceutical and Biomedical Analysis·2012· 34 cited
Measurement of Drug in Small Particles from Aqueous Nasal Sprays by Andersen Cascade Impactor
Pharmaceutical Research·2012· 17 cited
Characterization of currently marketed heparin products: Analysis of heparin digests by RPIP-UHPLC–QTOF-MS
Journal of Pharmaceutical and Biomedical Analysis·2012· 42 cited
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Frequent Co-authors

Benjamin J. Westenberger(17), David A. Keire(14), Ali Al‐Hakim(12), Moheb Nasr(11), William H. Doub(11), Anna M. Wokovich(10), John F. Kauffman(9), Richard E. Kolinski(8), Michael L. Trehy(8), John Spencer(7), John C. Reepmeyer(7), Hongping Ye(6), Nakissa Sadrieh(5), Terry W. Moore(5), Christine Moore(5), Jason D. Rodriguez(4), Wei Ye(4), Connie M. Gryniewicz-Ruzicka(4), Qingda Zang(4), Richard D. Wood(4)