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Robert Lionberger
Robert Lionberger
Office of Generic Drugs, Food and Drug Administration
Verified email at fda.hhs.gov
Title
Cited by
Cited by
Year
Quality by design: concepts for ANDAs
RA Lionberger, SL Lee, LM Lee, A Raw, LX Yu
The AAPS journal 10, 268-276, 2008
4802008
Applications of process analytical technology to crystallization processes
XY Lawrence, RA Lionberger, AS Raw, R D'Costa, H Wu, AS Hussain
Advanced drug delivery reviews 56 (3), 349-369, 2004
4102004
Generic development of topical dermatologic products: formulation development, process development, and testing of topical dermatologic products
RK Chang, A Raw, R Lionberger, L Yu
The AAPS journal 15, 41-52, 2013
3722013
Bioequivalence approaches for highly variable drugs and drug products
SH Haidar, B Davit, ML Chen, D Conner, LM Lee, QH Li, R Lionberger, ...
Pharmaceutical research 25, 237-241, 2008
2522008
High frequency modulus of hard sphere colloids
RA Lionberger, WB Russel
Journal of Rheology 38 (6), 1885-1908, 1994
2341994
FDA critical path initiatives: opportunities for generic drug development
RA Lionberger
The AAPS journal 10, 103-109, 2008
1412008
Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration
BM Davit, ML Chen, DP Conner, SH Haidar, S Kim, CH Lee, ...
The AAPS journal 14, 915-924, 2012
1402012
Utility of physiologically based absorption modeling in implementing quality by design in drug development
X Zhang, RA Lionberger, BM Davit, LX Yu
The AAPS journal 13, 59-71, 2011
1352011
In vitro and in vivo characterizations of PEGylated liposomal doxorubicin
W Jiang, R Lionberger, LX Yu
Bioanalysis 3 (3), 333-344, 2011
1192011
Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs
B Hens, Y Tsume, M Bermejo, P Paixao, MJ Koenigsknecht, JR Baker, ...
Molecular pharmaceutics 14 (12), 4281-4294, 2017
1152017
Pharmacokinetics-based approaches for bioequivalence evaluation of topical dermatological drug products
SG Raney, TJ Franz, PA Lehman, R Lionberger, ML Chen
Clinical pharmacokinetics 54, 1095-1106, 2015
992015
Generic development of topical dermatologic products, part II: quality by design for topical semisolid products
RK Chang, A Raw, R Lionberger, L Yu
The AAPS journal 15, 674-683, 2013
982013
The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
W Jiang, S Kim, X Zhang, RA Lionberger, BM Davit, DP Conner, ...
International journal of pharmaceutics 418 (2), 151-160, 2011
952011
A Smoluchowski theory with simple approximations for hydrodynamic interactions in concentrated dispersions
RA Lionberger, WB Russel
Journal of Rheology 41 (2), 399-425, 1997
941997
Generic lamotrigine versus brand‐name Lamictal bioequivalence in patients with epilepsy: a field test of the FDA bioequivalence standard
TY Ting, W Jiang, R Lionberger, J Wong, JW Jones, MA Kane, ...
Epilepsia 56 (9), 1415-1424, 2015
922015
Novel bioequivalence approach for narrow therapeutic index drugs
LX Yu, W Jiang, X Zhang, R Lionberger, F Makhlouf, DJ Schuirmann, ...
Clinical Pharmacology & Therapeutics 97 (3), 286-291, 2015
902015
Current challenges in bioequivalence, quality, and novel assessment technologies for topical products
A Yacobi, VP Shah, ED Bashaw, E Benfeldt, B Davit, D Ganes, T Ghosh, ...
Pharmaceutical research 31, 837-846, 2014
892014
Effect of Device Design on the In Vitro Performance and Comparability for Capsule-Based Dry Powder Inhalers
J Shur, S Lee, W Adams, R Lionberger, J Tibbatts, R Price
The AAPS journal 14, 667-676, 2012
892012
Modeling and simulation of the effect of proton pump inhibitors on magnesium homeostasis. 1. Oral absorption of magnesium
JPF Bai, E Hausman, R Lionberger, X Zhang
Molecular pharmaceutics 9 (12), 3495-3505, 2012
862012
Development of performance matrix for generic product equivalence of acyclovir topical creams
YSR Krishnaiah, X Xu, Z Rahman, Y Yang, U Katragadda, R Lionberger, ...
International journal of pharmaceutics 475 (1-2), 110-122, 2014
842014
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