Биопрепараты: Профилактика, диагностика, лечение (Feb 2018)
Comparative analysis of leading pharmacopoeias requirements for the quality of heterologous serum products
Abstract
The article is devoted to a comparative analysis of requirements to the heterologous serum products stipulated in the world leading Pharmacopoeias: the US Pharmacopoeia, the European Pharmacopoeia, the British Pharmacopoeia, the Japanese Pharmacopoeia and the State Pharmacopoeia of the Russian Federation. It was revealed that the range of antibacterial and antiviral heterologous serum products manufactured in the USA, Europe and Japan differs from that manufactured in Russia. Prevention and treatment of some infectious diseases abroad is mainly achieved with the help of human immunoglobulins, while the prevention of other infections, such as anthrax, is only achieved by vaccination. Nevertheless, heterologous serum products are still used in clinical practice all over the world. The range of such products is the same in all countries. Some of these products are included into the WHO Essential Medicines List. The results of the analysis demonstrate that Russian antitoxic serum products are not inferior to foreign analogues in terms of safety and efficacy. A more detailed characterization of Russian products could help harmonize requirements of Russian and foreign pharmacopoeias to these products and help Russian products enter the foreign market.
