Rationale of the methodological approach to the creation of combined drugs

Efficient development of new drugs is only possible with a reasonable design research, because it requires integrating and coordinating the efforts of specialists in different fields. Currently there is a huge package of documents, and manuals in the field of registration and production of medicines (drugs). However, there are no generally accepted scientific guidelines about primary research at the pharmaceutical development of combination drugs. Our proposed methodological approach to the primary (basic) investigations and developed on the basis of his scheme (algorithm) of design combination drugs with the well-known active pharmaceutical ingredients (APIs) allows to Optimize research and reduce the risk of a negative result at the final stages of development of the drug. Aim . To develop model for the initial design fixed-dose combination with known API and develop methodological approach to the creation of combined drugs. Results. The general scheme (algorithm) was developed for combined drugs based on the combination of well-known API. Conclusions. Offered methodological approach to designing a fixed combination of active substances, as part of the process of creating combined medicines.