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Journals and Conferences
At present the quality of generic drugs for registration in the Russian Federation is checked by studying their bioequivalence. According to FDA and WHO guidelines, some generic drugs can be registered on the basis of only in vitro data (dissolution test) without testing for the bioequivalence in vivo. A biowaiver procedure that is based on a… (More)
The essential biopharmaceutical properties affecting the ability of drugs to reach the systemic circulation are discussed. Properties such as biopharmaceutical solubility and intestinal permeability are described, along with methods of assessing them and interactions between drug transport and absorption across GIT membranes and levels of metabolism. The… (More)
General approaches to the validation of the pharmacopoeial Dissolution test are considered. The determination of the dissolution validation characteristics (specificity, accuracy, precision, linearity range, and robustness) is described. Specific features for validation of the assay of released drug using UV spectrophotometry and HPLC are described.
Both favorable pregnancy outcomes and fetal abnormalities have been associated with the use of tyrosine kinase inhibitors (TKIs) during pregnancy. The placental transfer of TKIs in humans is poorly understood. We observed women with chronic myeloid leukemia who used imatinib or nilotinib during the late pregnancy stages. The newborns had no birth… (More)
A method for assaying the antituberculosis drug thiozonide in plasma was developed and validated. Sample preparation consisted of precipitation of proteins with acetonitrile. Assay was by HPLC with a mass-selective detector. The method developed here was validated in terms of the following validation properties: selectivity, linearity, accuracy, precision,… (More)
One way of establishing the interchangeability of generic drugs is based on an in vitro study of the dissolution kinetics (biowaiver). The most common approaches for assessing the ability to use the biowaiver procedure instead of the traditional bioequivalence evaluation for generics are reviewed.
The review deals with the modern tool for modeling of drug behavior in vivo, - the dissolution test in biorelevant media, imitating gastrointestinal fluids. The formulations and preparation methods of fasted state simulation intestinal fluid, FaSSIF and fed state simulation intestinal fluid, FeSSIF, are defined. In addition, the dissolution characteristics… (More)
Comparative dissolution kinetics were studied for ropinirole formulations using two media with pH 4.0: phosphate buffered solution (200 rpm) and citrate buffer (100 rpm). The study results showed that the components of the dissolution medium affected release profiles and the stability of the active ingredient even at identical pH. The optimum dissolution… (More)
The application of HPLC and UPLC techniques to the analysis of drugs in blood plasma during bioequivalence investigations and clinical monitoring was reviewed. Various methods of sample preparation, chromatography, and detection were considered and their specific features were pointed out.