Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs-Reference-Cited by-同舟云学术

Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs

Published:2017-08-04 Issue:12 Volume:14 Page:4281-4294
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Hens Bart¹^ORCID,Tsume Yasuhiro¹,Bermejo Marival²,Paixao Paulo³,Koenigsknecht Mark J.¹^ORCID,Baker Jason R.⁴,Hasler William L.⁴,Lionberger Robert⁵,Fan Jianghong⁵,Dickens Joseph⁶,Shedden Kerby⁶,Wen Bo¹,Wysocki Jeffrey¹,Loebenberg Raimar⁷,Lee Allen²,Frances Ann¹,Amidon Greg¹,Yu Alex¹^ORCID,Benninghoff Gail¹,Salehi Niloufar⁸,Talattof Arjang¹,Sun Duxin¹,Amidon Gordon L.¹

Affiliation:

1. Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109, 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 Internal Medicine, Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan 48109, United States

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

6. Department of Statistics, University of Michigan, Ann Arbor, Michigan 48109, United States

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

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

Funder

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.7b00426

Reference71 articles.

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

2. Food & Drug Administration Guidance for Industry Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA 2013.

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

4. Gastrointestinal Motility Variation and Implications for Plasma Level Variation: Oral Drug Products

5. The migrating motor complex: control mechanisms and its role in health and disease

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