Evaluating the pharmaceutical equivalence of drugs in the registration stage

Evaluating the pharmaceutical equivalence of drugs in the registration stage

Comparative data on the dissolution kinetics profiles of more than 200 drug pairs have been analyzed. It is shown that the comparative dissolution test provides effective evaluation of the pharmacological equivalence during preclinical trials of generic drugs and the drugs with claimed changes in co...

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Veröffentlicht in:Pharmaceutical chemistry journal 2009-03, Vol.43 (3), p.171-175
Hauptverfasser: Korolev, A. V, Bokovikova, T. N, Luttseva, A. I, Milkina, S. E, Nechaeva, E. B, Sadchikova, N. P
Format: Artikel
Sprache:eng
Schlagworte:
dissolution test
generic drug
Medicine
Organic Chemistry
pharmaceutical equivalence
Pharmacology/Toxicology
Pharmacy
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Zusammenfassung:Comparative data on the dissolution kinetics profiles of more than 200 drug pairs have been analyzed. It is shown that the comparative dissolution test provides effective evaluation of the pharmacological equivalence during preclinical trials of generic drugs and the drugs with claimed changes in composition in the registration stage.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-009-0260-9