A Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long-Term Safety-Reference-Cited by-同舟云学术

A Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long-Term Safety

Published:2017-06-15 Issue:5 Volume:10 Page:387-394
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical And Translational Science

Author:

Dubcenco E¹²³⁴,Beers-Block PM²,Kim LP²,Schotland P³⁴,Levine JG⁴,McCloskey CA⁴,Bashaw ED⁴

Affiliation:

1. Robarts Clinical Trials Inc.; University of Western Ontario; London Ontario Canada

2. Rutgers; State University of New Jersey; The Biopharma Educational Initiative; Newark New Jersey USA

3. Oak Ridge Institute for Science and Education; Oak Ridge Tennessee USA

4. U.S. Food and Drug Administration; Silver Spring Maryland USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/cts.12475/fullpdf

Reference59 articles.

1. U.S. Food and Drug Administration http://www.fda.gov/downloads/Drugs/Guidances/ucm070244.pdff

2. U.S. Food and Drug administration Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations. Guidance for Industry http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm389370.pdf

3. Bioequivalence: Performance of several measures of extent of absorption;Bois;Pharm. Res,1994)

4. European Medicines Agency Committee for medicinal products for human use http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf

5. Perspectives in clinical gastroenterology and hepatology;Johnson;Clin. Gastroent. Hepatol,2013

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