Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans—Part 2: Fed State-Reference-Cited by-同舟云学术

Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans—Part 2: Fed State

Published:2018-11-12 Issue:12 Volume:15 Page:5468-5478
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Paixão Paulo¹²,Bermejo Marival¹³,Hens Bart¹⁴^ORCID,Tsume Yasuhiro¹,Dickens Joseph,Shedden Kerby,Salehi Niloufar⁵,Koenigsknecht Mark J.¹,Baker Jason R.⁶,Hasler William L.⁶,Lionberger Robert⁷,Fan Jianghong⁷,Wysocki Jeffrey¹,Wen Bo¹,Lee Allen⁶,Frances Ann¹,Amidon Gregory E.¹,Yu Alex¹^ORCID,Benninghoff Gail¹,Löbenberg Raimar⁸,Talattof Arjang¹^ORCID,Sun Duxin¹,Amidon Gordon L.¹^ORCID

Affiliation:

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

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

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

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

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

6. Department of Internal Medicine, Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan 48109, United States

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

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

Funder

KU Leuven

U.S. 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.8b00736

Reference36 articles.

1. Food and Drug Administration. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System: Draft Guidance for Industry; 2015.

2. Food and Drug Administration. Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies; 2002.

3. European Medicines Agency. Guideline On The Investigation of Bioequivalence; Doc. Ref: CPMP/EWP/QWP/1401/98; 2010.

4. Pharmaceuticals and Medical Devices Agency. Guideline for Bioequivalence Studies of Generic Products; Division-Notification 0229 No. 10; 2012.

5. Postprandial Changes in Solubilizing Capacity of Human Intestinal Fluids for BCS Class II Drugs

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