PRE-CLINICAL SAFETY EVALUATION OF PREPARATIONS CONTAINING A COMBINATION OF KNOWN DRUGS

Abstract

А program of investigational studies of new combined preparations containing known medications includes investigation into general toxic effect of a combination but does not plan investigations into toxicity of its active components. The medical application of these medications assumes that pre-clinical and clinical data proving their effectiveness and safety are sufficient. But a fragmentary and controversial nature of data about toxicity of drugs available to those involved in new drug development significantly restricts the use of literature data in characterizing a combination toxicity expected profile, predicting and identifying the interaction effects. A prognostic and experimental evaluation of active components toxicological interaction was performed using the example of the metamizole sodium and ibuprofen fixed combination. The adequacy evaluation of the program of investigational studies and interpretation results of the combined preparation toxicological assessment was carried out using a common analytical practice.