[Harmonization of testing drugs for bioequivalence: problems and possible solutions].
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.
Zherdev
V P
VP
Zakusov Institute of Pharmacology, Russian Academy of Medical Sciences, Baltiiskaya ul. 8, Moscow, 125315 Russia.
Kolyvanov
G B
GB
Litvin
A A
AA
Sariev
A K
AK
D001682:Biological Availability; D002986:Clinical Trials as Topic / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D026690:Ethics, Clinical; D006801:Humans; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000378:metabolism; D010597:Pharmacogenetics; D012680:Sensitivity and Specificity; D013810:Therapeutic Equivalency
D004364:Pharmaceutical Preparations
Garmonizatsiia provedeniia issledovaniĭ bioékvivalentnosti lekarstvennykh preparatov: voprosy i ikh vozmozhnoe reshenie.