Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base-Reference-Cited by-同舟云学术

Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base

Published:2016-04-20 Issue:5 Volume:28 Page:429-433
ISSN:0899-0042
Container-title:Chirality
language:en
Short-container-title:Chirality

Author:

García-Arieta Alfredo¹,Ferrero-Cafiero Juan Manuel²³,Puntes Montse²³,Gich Ignasi²³,Morales-Alcelay Susana¹,Tarré Maite⁴,Font Xavier⁴,Antonijoan Rosa Maria²³

Affiliation:

1. Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines; Spanish Agency for Medicines and Health Care Products; Madrid Spain

2. Centre d'Investigació de Medicaments, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. (CIM-Sant Pau); Barcelona Spain

3. Farmacologia Clínica, Hospital de la Santa Creu i Sant Pau, Departament de Farmacologia i Terapèutica; Universitat Autònoma de Barcelona; Barcelona Spain

4. Laboratorio de Aplicaciones Farmacodinámicas, S.A. (FARDI); Barcelona Spain

Publisher

Wiley

Subject

Organic Chemistry,Spectroscopy,Drug Discovery,Pharmacology,Catalysis,Analytical Chemistry

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/chir.22598/fullpdf

Reference20 articles.

1. US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research CDER Guidance for Industry 2003

2. Chiral bioequivalence: effect of absorption rate on racemic etodolac;Boni;Clin Pharmacokinet,2000

3. An eutomer/distomer ratio near unity does not justify non-enantiospecific assay methods in bioequivalence studies;Garcia-Arieta;Chirality,2005

4. Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies;Torrado;Eur J Clin Pharmacol,2010

5. Committee for Proprietary Medicinal Products & EMEA Guideline on the Investigation of Bioavailability and Bioequivalence 2010

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