Robert A Lionberger: search on Z-Library

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1

Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract

Yu, Alex, Baker, Jason R., Fioritto, Ann F., Wang, Ying, Luo, Ruijuan, Li, Siwei, Wen, Bo, Bly, Michael, Tsume, Yasuhiro, Koenigsknecht, Mark J., Zhang, Xinyuan, Lionberger, Robert, Amidon, Gordon L.,

Journal:

Molecular Pharmaceutics

Year:

2017

Language:

english

File:

PDF, 3.32 MB

english, 2017

2

Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products

André Sirota Raw, Robert Lionberger, Lawrence X. Yu

Journal:

Pharmaceutical Research

Year:

2011

Language:

english

File:

PDF, 187 KB

english, 2011

3

Scientific considerations in the review and approval of generic enoxaparin in the United States

Lee, Sau, Raw, Andre, Yu, Lawrence, Lionberger, Robert, Ya, Naiqi, Verthelyi, Daniela, Rosenberg, Amy, Kozlowski, Steve, Webber, Keith, Woodcock, Janet

Journal:

Nature Biotechnology

Year:

2013

Language:

english

File:

PDF, 639 KB

english, 2013

4

Development of performance matrix for generic product equivalence of acyclovir topical creams

Krishnaiah, Yellela S.R., Xu, Xiaoming, Rahman, Ziyaur, Yang, Yang, Katragadda, Usha, Lionberger, Robert, Peters, John R., Uhl, Kathleen, Khan, Mansoor A.

Journal:

International Journal of Pharmaceutics

Year:

2014

Language:

english

File:

PDF, 3.53 MB

english, 2014

5

Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective

Liu, Qing, Absar, Mohammad, Saluja, Bhawana, Guo, Changning, Chowdhury, Badrul, Lionberger, Robert, Conner, Dale P., Li, Bing V.

Journal:

The AAPS Journal

Year:

2019

Language:

english

File:

PDF, 2.32 MB

english, 2019

6

Using Partial Area for Evaluation of Bioavailability and Bioequivalence

Mei-Ling Chen, Barbara Davit, Robert Lionberger, Zakaria Wahba, Hae-Young Ahn, Lawrence X. Yu

Journal:

Pharmaceutical Research

Year:

2011

Language:

english

File:

PDF, 315 KB

english, 2011

7

Quality by Design: Concepts for ANDAs

Robert A. Lionberger, Sau Lawrence Lee, LaiMing Lee, Andre Raw, Lawrence X. Yu

Journal:

The AAPS Journal

Year:

2008

Language:

english

File:

PDF, 152 KB

english, 2008

8

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

Xinyuan Zhang, Robert A. Lionberger, Barbara M. Davit, Lawrence X. Yu

Journal:

The AAPS Journal

Year:

2011

Language:

english

File:

PDF, 455 KB

english, 2011

9

A Sensitivity Analysis of the Modified Chi-square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution

Weber, Benjamin, Lee, Sau L., Lionberger, Robert, Li, Bing V., Tsong, Yi, Hochhaus, Guenther

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 365 KB

english, 2013

10

Integrating in vitro, modeling, and in vivo approaches to investigate warfarin bioequivalence

Zhang, Xinyuan, Wen, Hong, Fan, Jianghong, Vince, Bradley, Li, Tonglei, Gao, Wei, Kinjo, Minori, Brown, Jill, Sun, Wanjie, Jiang, Wenlei, Lionberger, Robert

Journal:

CPT: Pharmacometrics & Systems Pharmacology

Year:

2017

Language:

english

File:

PDF, 1.10 MB

english, 2017

11

Generic Drugs: Expanding Possibilities for Clinical Pharmacology

Lionberger, Robert, Uhl, Kathleen

Journal:

Clinical Pharmacology & Therapeutics

Year:

2019

Language:

english

File:

PDF, 172 KB

english, 2019

12

Generics 2030: Where Are We Heading in 2030 for Generic Drug Science, Research, and Regulation?

Zhang, Lei, Lionberger, Robert A.

Journal:

Clinical Pharmacology & Therapeutics

Year:

2020

Language:

english

File:

PDF, 153 KB

english, 2020

13

Spreadability Measurements to Assess Structural Equivalence (Q3) of Topical Formulations—A Technical Note

David R. Kryscio, Pradeep M. Sathe, Robert Lionberger, Lawrence Yu, Michael A. Bell, Michael Jay, J. Zach Hilt

Journal:

AAPS PharmSciTech

Year:

2008

Language:

english

File:

PDF, 99 KB

english, 2008

14

Applications of process analytical technology to crystallization processes

Lawrence X Yu, Robert A Lionberger, Andre S Raw, Rosario D'Costa, Huiquan Wu, Ajaz S Hussain

Journal:

Advanced Drug Delivery Reviews

Year:

2004

Language:

english

File:

PDF, 552 KB

english, 2004

15

The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation

Wenlei Jiang, Stephanie Kim, Xinyuan Zhang, Robert A. Lionberger, Barbara M. Davit, Dale P. Conner, Lawrence X. Yu

Journal:

International Journal of Pharmaceutics

Year:

2011

Language:

english

File:

PDF, 773 KB

english, 2011

16

US FDA question-based review for generic drugs: A new pharmaceutical quality assessment system

Yu, Lawrence X, Raw, Andre, Lionberger, Robert, Rajagopalan, Radhika, Lee, Lai Ming, Holcombe, Frank, Patel, Rashmikant, Fang, Florence, Sayeed, Vilayat, Schwartz, Paul, Adams, Richard, Buehler, Gary

Journal:

Journal of Generic Medicines The Business Journal for the Generic Medicines Sector

Year:

2007

Language:

english

File:

PDF, 130 KB

english, 2007

17

A Stability Analysis of a Modified Version of the Chi-Square Ratio Statistic: Implications for Equivalence Testing of Aerodynamic Particle Size Distribution

Weber, Benjamin, Hochhaus, Guenther, Adams, Wallace, Lionberger, Robert, Li, Bing, Tsong, Yi, Lee, Sau L.

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 365 KB

english, 2013

18

Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

Stier, Ethan M., Davit, Barbara M., Chandaroy, Parthapratim, Chen, Mei-Ling, Fourie-Zirkelbach, Jeanne, Jackson, Andre, Kim, Stephanie, Lionberger, Robert, Mehta, Mehul, Uppoor, Ramana S., Wang, Yanin

Journal:

The AAPS Journal

Year:

2012

Language:

english

File:

PDF, 145 KB

english, 2012

19

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

Jiang, Wenlei, Makhlouf, Fairouz, Schuirmann, Donald J., Zhang, Xinyuan, Zheng, Nan, Conner, Dale, Yu, Lawrence X., Lionberger, Robert

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 698 KB

english, 2015

20

Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products

Raney, Sam G., Franz, Thomas J., Lehman, Paul A., Lionberger, Robert, Chen, Mei-Ling

Journal:

Clinical Pharmacokinetics

Year:

2015

Language:

english

File:

PDF, 519 KB

english, 2015

21

Modeling and mechanistic approaches for oral absorption: quality by design in action

Yu, Lawrence, Zhang, Xinyuan, Lionberger, Robert

Journal:

Therapeutic Delivery

Year:

2012

Language:

english

File:

PDF, 1.07 MB

english, 2012

22

Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

Zhang, Xinyuan, Duan, John, Kesisoglou, Filippos, Novakovic, Jasmina, Amidon, Gordon, Jamei, Masoud, Lukacova, Viera, Eissing, Thomas, Tsakalozou, Eleftheria, Zhao, Liang, Lionberger, Robert

Journal:

CPT: Pharmacometrics & Systems Pharmacology

Year:

2017

Language:

english

File:

PDF, 631 KB

english, 2017

23

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

Fang, Lanyan, Kim, Myong-Jin, Li, Zhichuan, Wang, Yaning, DiLiberti, Charles E., Au, Jessie, Hooker, Andrew, Ducharme, Murray P., Lionberger, Robert, Zhao, Liang

Journal:

Clinical Pharmacology & Therapeutics

Year:

2018

Language:

english

File:

PDF, 148 KB

english, 2018

24

Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance

Hu, Meng, Jiang, Xiaohui, Absar, Mohammad, Choi, Stephanie, Kozak, Darby, Shen, Meiyu, Weng, Yu-Ting, Zhao, Liang, Lionberger, Robert

Journal:

The AAPS Journal

Year:

2018

Language:

english

File:

PDF, 2.53 MB

english, 2018

25

Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach

Paixão, Paulo, Bermejo, Marival, Hens, Bart, Tsume, Yasuhiro, Dickens, Joseph, Shedden, Kerby, Salehi, Niloufar, Koenigsknecht, Mark J., Baker, Jason R., Hasler, William L., Lionberger, Robert, Fan, J

Journal:

European Journal of Pharmaceutics and Biopharmaceutics

Year:

2018

Language:

english

File:

PDF, 1.50 MB

english, 2018

26

Treatment of rheumatoid synovitis of the knee with intraarticular injection of dysprosium 165-ferric hydroxide macroaggregates

Clement B. Sledge, Joseph D. Zuckerman, Michael R. Zalutsky, Robert W. Atcher, Sonya Shortkroff, David R. Lionberger, Howard A. Rose, Brian J. Hurson, Peter A. Lankenner Jr., Ronald J. Anderson, Willi

Journal:

Arthritis & Rheumatism

Year:

1986

Language:

english

File:

PDF, 728 KB

english, 1986

27

Bioequivalence Approaches for Highly Variable Drugs and Drug Products

Sam H. Haidar, Barbara Davit, Mei-Ling Chen, Dale Conner, LaiMing Lee, Qian H. Li, Robert Lionberger, Fairouz Makhlouf, Devvrat Patel, Donald J. Schuirmann, Lawrence X. Yu

Journal:

Pharmaceutical Research

Year:

2008

Language:

english

File:

PDF, 103 KB

english, 2008

28

FDA Critical Path Initiatives: Opportunities for Generic Drug Development

Robert A. Lionberger

Journal:

The AAPS Journal

Year:

2008

Language:

english

File:

PDF, 144 KB

english, 2008

29

Analysis of Bead Sizes for MR Capsules Labeled for Sprinkle

Laxma R. Nagavelli, Robert A. Lionberger, Vilayat A. Sayeed, Lawrence Yu, James Allgire, Anjanette Smith, Anna Wokovich, Benjamin J. Westenberger, Lucinda Buhse

Journal:

AAPS PharmSciTech

Year:

2010

Language:

english

File:

PDF, 79 KB

english, 2010

30

Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations

Robert A. Lionberger, Andre S. Raw, Stephanie H. Kim, Xinyuan Zhang, Lawrence X. Yu

Journal:

Pharmaceutical Research

Year:

2012

Language:

english

File:

PDF, 25.61 MB

english, 2012

31

Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

Davit, Barbara M., Chen, Mei-Ling, Conner, Dale P., Haidar, Sam H., Kim, Stephanie, Lee, Christina H., Lionberger, Robert A., Makhlouf, Fairouz T., Nwakama, Patrick E., Patel, Devvrat T., Schuirmann,

Journal:

The AAPS Journal

Year:

2012

Language:

english

File:

PDF, 404 KB

english, 2012

32

Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Chang, Rong-Kun, Raw, Andre, Lionberger, Robert, Yu, Lawrence

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 222 KB

english, 2013

33

In vitro and in vivo characterizations of PEGylated liposomal doxorubicin

Jiang, Wenlei, Lionberger, Robert, Yu, Lawrence X

Journal:

Year:

2011

Language:

english

File:

PDF, 3.49 MB

english, 2011

34

Effects of Device and Formulation onIn VitroPerformance of Dry Powder Inhalers

Adams, Wallace P., Lee, Sau L., Plourde, Robert, Lionberger, Robert A., Bertha, Craig M., Doub, William H., Bovet, Jean-Marc, Hickey, Anthony J.

Journal:

The AAPS Journal

Year:

2012

Language:

english

File:

PDF, 430 KB

english, 2012

35

[AIP The 8th tohwa university international symposium on slow dynamics in complex systems - Fukuoka (Japan) (9-14 Nov 1998)] AIP Conference Proceedings - Associated and polymerically stabilized dispersions

Russel, William B., Elliott, Stacey, Lionberger, Robert A.

Year:

1999

Language:

english

File:

PDF, 1.14 MB

english, 1999

36

Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products

Chang, Rong-Kun, Raw, Andre, Lionberger, Robert, Yu, Lawrence

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 316 KB

english, 2013

37

Viscosity of bimodal and polydisperse colloidal suspensions

Lionberger, Robert A.

Journal:

Physical Review E

Year:

2002

Language:

english

File:

PDF, 148 KB

english, 2002

38

Innovative approaches for demonstration of bioequivalence: the US FDA perspective

Zhang, Xinyuan, Zheng, Nan, Lionberger, Robert A, Yu, Lawrence X

Journal:

Therapeutic Delivery

Year:

2013

Language:

english

File:

PDF, 1.00 MB

english, 2013

39

CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

Cruz, Celia N., Tyner, Katherine M., Velazquez, Lydia, Hyams, Kenneth C., Jacobs, Abigail, Shaw, Arthur B., Jiang, Wenlei, Lionberger, Robert, Hinderling, Peter, Kong, Yoon, Brown, Paul C., Ghosh, Tap

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 230 KB

english, 2013

40

Effect of Device Design on theIn VitroPerformance and Comparability for Capsule-Based Dry Powder Inhalers

Jagdeep Shur, Sau Lee, Wallace Adams, Robert Lionberger, James Tibbatts…

Journal:

The AAPS Journal

Year:

2012

Language:

english

File:

PDF, 505 KB

english, 2012

41

Impact of P-Glycoprotein-Mediated Intestinal Efflux Kinetics on Oral Bioavailability of P-Glycoprotein Substrates †

Kwon, Hyojong, Lionberger, Robert A., Yu, Lawrence X.

Journal:

Molecular Pharmaceutics

Year:

2004

Language:

english

File:

PDF, 171 KB

english, 2004

42

Modeling and Simulation of the Effect of Proton Pump Inhibitors on Magnesium Homeostasis. 1. Oral Absorption of Magnesium

Bai, Jane P. F., Hausman, Ethan, Lionberger, Robert, Zhang, Xinyuan

Journal:

Molecular Pharmaceutics

Year:

2012

Language:

english

File:

PDF, 1.84 MB

english, 2012

43

Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

Yacobi, Avraham, Shah, Vinod P., Bashaw, Edward D., Benfeldt, Eva, Davit, Barbara, Ganes, Derek, Ghosh, Tapash, Kanfer, Isadore, Kasting, Gerald B., Katz, Lindsey, Lionberger, Robert, Lu, Guang Wei, M

Journal:

Pharmaceutical Research

Year:

2014

Language:

english

File:

PDF, 255 KB

english, 2014

44

Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing

Weber, Benjamin, Lee, Sau L., Delvadia, Renishkumar, Lionberger, Robert, Li, Bing V., Tsong, Yi, Hochhaus, Guenther

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 657 KB

english, 2015

45

International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

Lu, Dongmei, Lee, Sau L., Lionberger, Robert A., Choi, Stephanie, Adams, Wallace, Caramenico, Hoainhon N., Chowdhury, Badrul A., Conner, Dale P., Katial, Rohit, Limb, Susan, Peters, John R., Yu, Lawre

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 339 KB

english, 2015

46

Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

Jiang, Wenlei, Makhlouf, Fairouz, Schuirmann, Donald J., Zhang, Xinyuan, Zheng, Nan, Conner, Dale, Yu, Lawrence X., Lionberger, Robert

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 71 KB

english, 2015

47

Generic omeprazole delayed-release capsules: in vitro performance evaluations

Moore, Terry, Smith, Anjanette, Ye, Wei, Toler, Duckhee Y., Westenberger, Benjamin J., Lionberger, Robert, Raw, Andre, Yu, Lawrence, Buhse, Lucinda F.

Journal:

Drug Development and Industrial Pharmacy

Year:

2009

Language:

english

File:

PDF, 234 KB

english, 2009

48

Clinical, Pharmacokinetic, andIn VitroStudies to Support Bioequivalence of Ophthalmic Drug Products

Choi, Stephanie H., Lionberger, Robert A.

Journal:

The AAPS Journal

Year:

2016

Language:

english

File:

PDF, 489 KB

english, 2016

49

Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Chang, Rong-Kun, Raw, Andre, Lionberger, Robert, Yu, Lawrence

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 82 KB

english, 2015

50

Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard

Ting, Tricia Y., Jiang, Wenlei, Lionberger, Robert, Wong, Jessica, Jones, Jace W., Kane, Maureen A., Krumholz, Allan, Temple, Robert, Polli, James E.

Journal:

Year:

2015

Language:

english

File:

PDF, 423 KB

english, 2015