20.500.12556/RUL-162173 Matrixing designs for shelf-life determination of parenteral drug product a comparative analysis of full and reduced stability testing design This article highlights the applicability of matrixing designs in stability studies for parenteral medications. The traditional approach involves extensive testing over the product’s shelf-life. However, matrixing designs offer an alternative approach where only a fraction of samples is tested at each time point. The study conducted in this article focused on three parenteral medications and examined stability data under long-term condition. Degradation products were identified as critical parameter, and kinetics of degradation varied among the selected products. A systematic methodology was adopted to evaluate the data using different matrixing designs. The regression models obtained were assessed using statistical parameters S and R$^2$. Also, each of the 28 matrixing designs were compared to the full design with statistical parameter RMSE and the shelf-life. The results confirmed that each of the evaluated matrixing designs can be applied, whether degradation product shows a linear or non-linear increase, and demonstrated that a reduction of two time points per batch is the most appropriate. In conclusion, this research contributes to the understanding of utilizing reduced matrixing designs in stability studies for parenteral medications and can be an effective strategy to reduce costs and time of stability testing while maintaining the necessary level of precision and reliability. shelf-life matrixing design ICH Q1D stability study degradation kinetics parenteral dosage forms rok uporabnosti matrično oblikovanje ICH Q1D študija stabilnosti kinetika razgradnje parenteralne dozirne oblike zdravila true false true Angleški jezik Slovenski jezik Članek v reviji 2024-09-19 11:06:47 2024-09-19 11:06:53 2024-09-23 03:31:23 0000-00-00 00:00:00 2024 0 0 12 str. iss. 9, art. 1117 Vol. 16 2024 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 615 1999-4923 10.3390/pharmaceutics16091117 206005507 pharmaceutics-16-01117-v2.pdf pharmaceutics-16-01117-v2.pdf 1 81394D5CDAE888046F11CA003BBBB5AD 4e374004e9374b136be04416f9c8fa5ed221b9317732fcb71cf7ecafc36c3de9 69b13169-7667-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=191342 https://www.mdpi.com/1999-4923/16/9/1117 1 68ce732e-7666-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=191341 Fakulteta za farmacijo 0 0 0