Good Preclinical Study, as an Obligatory Stage in Design and Clinical Use of New Medicinal Preparations

Abstract

Preclinical studies are investigations, performed in vitro and in vivo (on animals) prior to clinical trials in men. They play the main role in design of medicinal preparations. Preclinical studies provide research of new compounds with useful biopharma-ceutical and pharmacokinetic properties. In addition, they to make shorter the period between isolation of a novel active substance and its further development within the clinical trials, as well as to lower the time and materials expenditures for the clinical trials. There are three aspects of the preclinical study: investigation of the pharmacological activity of the main substance, investigation of the pharmacokinetic properties of the active substance and its medicinal preparation and investigation of the toxicological properties of the active substance. The requirements for preclinical studies on medicinal preparations and practical examples are presented.

Keywords

• glp - надлежащая лабораторная практика
• good laboratory practice (glp)
• immunomodulators