DORI VOSITALARI SIFAT NAZORATIDA PAT VA ZAMONAVIY ANALITIK USULLARNING O‘RNI
Keywords:
sifat nazorati, farmatsevtika, HPLC, LC-MS/MS, NIR spektroskopiyasi, NMR, ICP-MS, PAT, GMP, sun’iy intellekt.Abstract
Dori vositalarining sifati, xavfsizligi va samaradorligini ta’minlash zamonaviy farmatsevtika sanoatining eng muhim vazifalaridan biri hisoblanadi. Farmatsevtika mahsulotlariga bo‘lgan talabning ortib borishi, yangi dori shakllarining yaratilishi hamda xalqaro standartlarga mos ishlab chiqarishni yo‘lga qo‘yish zarurati sifat nazoratining zamonaviy usullarini joriy etishni taqozo etmoqda. Shu sababli analitik texnologiyalar va raqamli nazorat tizimlarining qo‘llanilishini o‘rganish dolzarb ahamiyat kasb etadi.
References
International Council for Harmonisation (ICH). (2022). ICH Q2(R2) Guideline: Validation of Analytical Procedures. Geneva: ICH Secretariat.
U.S. Food and Drug Administration. (2004). PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Rockville: FDA.
European Pharmacopoeia, 11th Edition. (2023). Council of Europe, Strasbourg. European Directorate for the Quality of Medicines & HealthCare (EDQM).
United States Pharmacopeia (USP 46). (2023). United States Pharmacopeial Convention. Rockville, MD.
Schweitzer, M., et al. (2010). Implications and opportunities of applying QbD principles to analytical measurements. Pharmaceutical Technology, 34(2), 52–59.
Bakeev, K. A. (Ed.). (2010). Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries (2nd ed.). Wiley-Blackwell.
De Beer, T., et al. (2011). Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. International Journal of Pharmaceutics, 417(1–2), 32–47.
Rozet, E., et al. (2011). Analysis of recent pharmaceutical regulatory documents on analytical method validation. Journal of Chromatography A, 1218(32), 5373–5383.
Simoens, S. (2011). Biosimilar medicines and cost-effectiveness. ClinicoEconomics and Outcomes Research, 3, 29–36.
Ministry of Health of the Republic of Uzbekistan. (2021). Regulation on the Procedure for Registration and Quality Control of Medicinal Products in the Republic of Uzbekistan. Tashkent: Ministry of Health Publishing House.
Downloads
Published
Issue
Section
How to Cite
