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Bioequivalence between generic tacrolimus products marketed in Spain by adjusted indirect comparison.
MedLine Citation:
PMID:  23196824     Owner:  NLM     Status:  Publisher    
PURPOSE: The objective of the study was to investigate the relative bioavailability between the generic tacrolimus products that are presently authorized in Spain by adjusted indirect comparison. This was based on demonstration of bioequivalence with the reference product (Prograf, Astellas Pharma), which makes these generic tacrolimus products prescribable, switchable and therapeutically equivalent to the reference product; yet, according to Spanish legislation, only prescribers can switch tacrolimus-containing products. METHODS: Data from independent bioequivalence studies that compare each generic product with the reference product were combined by adjusted indirect comparisons to investigate the relative bioavailability between generic drug products, since there is no direct bioequivalence study comparing generics to each other. RESULTS: Eight generic tacrolimus products in the form of capsules are presently authorized in Spain, but only five are marketed. These eight products represent only three different generic product developments. One product is authorized with four different names/companies, while another is authorized under three different names/companies. The adjusted indirect comparisons between generic products show bioequivalence within the conventional 80-125 % confidence interval acceptance criteria for area under the curve (AUC) and maximum concentration (Cmax). CONCLUSION: Not only are the generic products bioequivalent with the reference product, but also with each other.
Marta Herranz; Susana Morales-Alcelay; Ma Teresa Corredera-Hernández; José María de la Torre-Alvarado; Antonio Blázquez-Pérez; Ma Luisa Suárez-Gea; Covadonga Alvarez; Alfredo García-Arieta
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-30
Journal Detail:
Title:  European journal of clinical pharmacology     Volume:  -     ISSN:  1432-1041     ISO Abbreviation:  Eur. J. Clin. Pharmacol.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-30     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  1256165     Medline TA:  Eur J Clin Pharmacol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
División de Farmacología y Evaluación Clínica, Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, C/Campezo 1. Edificio 8, Planta 2 Oeste, 28022, Madrid, Spain.
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