Abstract:

Non-biological complex medications have come to us as a new group of medications in recent years. These complex medicines are medical products that do not belong to the class of chemical and biological medicines, the active substance is not in the homo-molecular structure, which cannot be isolated by the latest technology physico-chemical analytical methods, which cannot be fully quantitative and characterized, which cannot be chemically synthesized, which is not biological, which is mostly complex with nanoparticular systems. Non-biological complex medications include liposomes, glatiramoids, iron carbohydrate complexes, polymeric patterns and nano-medicines. These drugs differ from biological and chemical drugs in terms of preparation technology. The biggest problem arising during the production of non-biological complex drugs is that the production process is uncontrollable, and therefore there are differences between the series. In these products, such as biobenzer products, not every different series production is the same, the same product is obtained. The size and size of non-biological complex drugs, such as surface load and composition, physical and chemical characteristics are factors affecting their interactions with biological systems, and therefore their biological activity. Although they are not obtained from living sources, they have immunity and molecular complexity, such as biological drugs. Even small changes in the process of production of these medicinal products can lead to unwanted immune system responses, safety problems, and a decrease in therapeutic effects. The requirements for licensing of these medicines are not fully established in national and international legal regulations. There are differences in legal regulations regarding non-biological complex drugs between EMA and the FDA. Therefore, in order to ensure that these products can be used effectively and safely, the requirements of global harmonisation and the guidelines to be followed during and after the approval process must be published. Research on farmacodynamic, pharmacokinetic and adverse effects on these products is insufficient. This collection contains general information about liposomes, glatiramoids, iron carbohydrate complexes and polymeric patterns.

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