Zdoryk O. Methodology approaches formation for the pharmacopoeial standardization of compounded preparations

The dissertation is devoted to the creation of the national pharmacopoeial quality control conception for compounded preparations by the formation of scientifically grounded methodological approaches for the development of general chapters and monographs for compounded preparations for the State Pharmacopoeia of Ukraine. For the first time, systematic investigations of the risks assessment while compounding and quality control of compounded preparations in liquid forms were conducted and general strategy for quality assurance of compounded preparations was defined; approach for validation of compounding technology was developed; theoretically substantiated and experimentally validated the suitability of some rapid analysis methods for the identification and quantification of liquid dosage forms compounded in pharmacies; theoretically substantiated approach to the stability study of compounded preparations and tested in determining the terms and conditions of storage of 16 liquid medicines. For the first time, the development of the chapter of “Pharmaceutical calculations while compounding” and the table “Maximal recommended therapeutic doses of active pharmaceutical ingredients for adults” were scientifically grounded and included into the national part of the State Pharmacopoeia of Ukraine