Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans—Part 1: Fasted State Conditions-Reference-Cited by-同舟云学术

Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans—Part 1: Fasted State Conditions

Published:2018-10-29 Issue:12 Volume:15 Page:5454-5467
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Bermejo Marival¹²,Paixão Paulo³,Hens Bart¹⁴^ORCID,Tsume Yasuhiro¹,Koenigsknecht Mark J.¹^ORCID,Baker Jason R.,Hasler William L.,Lionberger Robert⁵,Fan Jianghong⁵,Dickens Joseph,Shedden Kerby,Wen Bo¹,Wysocki Jeffrey¹,Löbenberg Raimar⁶,Lee Allen¹,Frances Ann¹,Amidon Gregory E.¹,Yu Alex¹^ORCID,Salehi Niloufar⁷,Talattof Arjang¹^ORCID,Benninghoff Gail¹,Sun Duxin¹,Kuminek Gislaine¹,Cavanagh Katie L.¹,Rodríguez-Hornedo Naír¹^ORCID,Amidon Gordon L.¹

Affiliation:

1. Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, Michigan 48109-1065, United States

2. Department of Engineering, Pharmacy Section, Miguel Hernandez University, San Juan de Alicante, 03550 Alicante, Spain

3. Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Avenida Professor Gama Pinto, 1649-003 Lisboa, Portugal

4. Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Herestraat 49, 3000 Leuven, Belgium

5. Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, United States

6. Faculty of Pharmacy & Pharmaceutical Sciences, University of Alberta, Edmonton, Alberta, Canada T6G 2H7

7. Center for the Study of Complex Systems and Department of Chemical Engineering, University of Michigan, Ann Arbor, Michigan 48109-2136, United States

Funder

KU Leuven

Food and Drug Administration

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.8b00515

Reference48 articles.

1. Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

2. Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report

3. Exploring gastrointestinal variables affecting drug and formulation behavior: Methodologies, challenges and opportunities

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