Abstract:

This article represents the comparative studies of generic drug on the basis of temozolomide and original drug TEMODAL® using methods in vitro and test "Dissolution", followed by the procedure of state registration of product as biowaiver which involves the obtaining of permission for the medical use of the drug without conduction of clinical trials. On the basis of conducted comparative studies, as a result it was shown that the substance temozolomide belongs to the first class of biopharmaceutical classification system (BCS) and has high solubility and high degree of penetration through biological membranes and drugs refer to very rapidly dissolving, and have similar dissolution profiles. It is concluded that the referent and investigated drugs are equivalent and can be used interchangeably in the medical practice.

Keywords: temozolomide, biowaiver, anticancer drug, test "Dissolution"