Bioequivalence challenges in development of fixed-dose combination products : looking beyond reformulation

INTRODUCTION: Bioequivalence study is a critical step in the development of novel fixed-dose combination products (FDCPs). While bioequivalence of prototype FDCP to the approved monocomponent products facilitates speedier development and approval, lack of bioequivalence often leads to development de...

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Bibliographic Details
Published in:Expert opinion on drug delivery, Vol. 9, No. 3 (2012), p. 325-32
Main Author: Dubey, Rajesh (Author)
Format: electronic Article
Language:English
ISSN:1744-7593
Item Description:Date Completed 10.04.2013
Date Revised 01.12.2018
published: Print-Electronic
Citation Status MEDLINE
Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Physical Description:Online-Ressource
DOI:10.1517/17425247.2012.655723
Subjects:
Journal Article
Review
Area Under Curve
*Chemistry, Pharmaceutical
*Drug Combinations
Drug Interactions
Humans
*Therapeutic Equivalency
Drug Combinations
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Published in:
Expert opinion on drug delivery, Vol. 9, No. 3 (2012), p. 325-32
Further Information:
http://dx.doi.org/10.1517/17425247.2012.655723
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