Regulatory framework on bioequivalence criteria for locally acting gastrointestinal drugs: the case for oral modified release mesalamine formulations-Reference-Cited by-同舟云学术

Regulatory framework on bioequivalence criteria for locally acting gastrointestinal drugs: the case for oral modified release mesalamine formulations

Published:2017-07-06 Issue:9 Volume:10 Page:1007-1019
ISSN:1751-2433
Container-title:Expert Review of Clinical Pharmacology
language:en
Short-container-title:Expert Review of Clinical Pharmacology

Author:

Sferrazza Gianluca¹,Siviero Paolo D²,Nicotera Giuseppe¹,Turella Paola³,Serafino Annalucia¹,Blandizzi Corrado⁴,Pierimarchi Pasquale¹

Affiliation:

1. Institute of Translational Pharmacology, National Research Council, Rome, Italy

2. Principia SGR s.p.a., Milan, Italy

3. Pharma Unit - pre-submission Analysis and Strategy, Intexo S.r.l., Rome, Italy

4. Department of clinical and Experimental Medicine, Unit of Pharmacology and Pharmacovigilance, University of Pisa, Pisa, Italy

Funder

Italian Ministry of Education, University and Research

Institute of Translational Pharmacology

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Pharmacology, Toxicology and Pharmaceutics,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/17512433.2017.1348227

Reference99 articles.

1. European medicines Agency. Generic medicine definition. 2012 [cited 2017, May 15]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000335.jsp&mid=WC0b01ac0580514d5c

2. Food and Drug Administration. Generic drugs: question and answer. 2017 [cited 2017, May 15]. Available from: https://www.fda.gov/drugs/resourcesforyou/consumers/questionsanswers/ucm100100.htm

3. Food and Drug Administration. Guidance for Industry. ANDA Submissions - Content and format of abbreviated new drug Applications. 2014 [cited 2017, May 15]. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm400630.pdf

4. European Parliament. Directive 2001/83/EC relating to medicinal products for human use. 2001 [cited 2017, May 15]. Available from: http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf

5. Food and Drug Administration. Guidance for Industry. Bioavailability and Bioequivalence. Studies for Orally Adminsitered Drug Products - General Considerations. 2003 [cited 2017, May 15]. Available from: https://www.fda.gov/ohrms/dockets/ac/03/briefing/3995B1_07_GFI-BioAvail-BioEquiv.pdf

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