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Harmonization of testing drugs for bioequivalence: problems and possible solutions

Zherdev, V.P.; Kolyvanov, G.B.; Litvin, A.A.; Sariev, A.K.

Eksperimental'naia i Klinicheskaia Farmakologiia 66(2): 60-64

2003

ISSN/ISBN: 0869-2092
PMID: 12962051
Document Number: 561868
Problems encountered in the testing for bioequivalence of reproduced drugs (generics) are discussed in the parts incompletely resolved in domestic methodological recommendations. There are special cases when such drugs significantly vary in concentration and dosage, contain endogenous substances, exhibit intensive metabolism with a genetically polymorphous component, belong to "long-lived" compounds, and are intended for local administration. Also mentioned are problems related to insufficient sensitivity of analytical methods and some ethical aspects of investigations.

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