title: [PLANNING THE DESIGN AND ESTIMATING THE RESULTS OF INVESTIGATIONS OF BIOEQUIVALENCE OF HIGHLY VARIABLE DRUGS BY EXAMPLE OF ROSUVASTATIN].
abstract: The article gives a definition of highly variable drugs, describes currently existing regulatory guidance and approaches to the study of bioequivalence of highly variable drugs, and formulates recommendations on the design and evaluation of the results of studies of such drugs. These aspects are considered by the example of calculations based on actual data from the registration dossiers materials for rosuvastatin.
authors: D P
authors: DP
authors: Romodanovskii
authors: M A
authors: MA
authors: Dranitsyna
authors: D V
authors: DV
authors: Goryachev
authors: R R
authors: RR
authors: Niyazov
authors: E V
authors: EV
authors: Gavrishina
mesh_terms: D002986:Clinical Trials as Topic; D005464:Fluorobenzenes / Q000493:pharmacokinetics*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000493:pharmacokinetics*; D008954:Models, Biological; D011743:Pyrimidines / Q000493:pharmacokinetics*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000493:pharmacokinetics*
chemical_list: D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium