Organisation of the Work of Bioanalytical Laboratories according to the Principles of Good Clinical Laboratory Practice (Review) ; Организация деятельности биоаналитических лабораторий согласно принципам надлежащей клинической лабораторной практики (обзор)

Συγγραφείς: I. S. Giba, И. С. Гиба

Συνεισφορές: The author would like to extend his gratitude and acknowledgements to Konstantin Yu. Semenov for participating in manuscript discussion., Автор выражает признательность и благодарность К.Ю. Семенову за участие в обсуждении рукописи.

Πηγή: Regulatory Research and Medicine Evaluation; Том 14, № 5 (2024); 601-611 ; Регуляторные исследования и экспертиза лекарственных средств; Том 14, № 5 (2024); 601-611 ; 3034-3453 ; 3034-3062 ; 10.30895/1991-2919-2024-14-5

Θεματικοί όροι: требования GCP, Good Clinical Laboratory Practices, bioanalysis, bioequivalence study, efficacy and safety, non-clinical studies, clinical trials, development of analytical procedures, validation of analytical procedures, quality management system, bioanalytical laboratories, GLP requirements, Good Laboratory Practices, GCP requirements, Good Clinical Practices, биоаналитика, исследования биоэквивалентности, эффективность и безопасность, доклинические исследования, клинические исследования, разработка и валидация аналитических методик, система менеджмента качества, биоаналитические лаборатории, требования GLP

Περιγραφή αρχείου: application/pdf

Relation: https://www.vedomostincesmp.ru/jour/article/view/645/1702; https://www.vedomostincesmp.ru/jour/article/downloadSuppFile/645/690; Гиба ИС, Салиева КР, Батуева АА, Григорьева ИВ, Драй РВ. Внедрение и оценка системы менеджмента качества в области фармацевтической разработки биотехнологических лекарственных препаратов. Ведомости Научного центра экспертизы средств медицинского применения. Регуляторные исследования и экспертиза лекарственных средств. 2024;14(1):62–71. https://doi.org/10.30895/1991-2919-2023-549; Рогов ЕС, Белоусов ДЮ, Зырянов СК, Колбин АС, Карпенко ЛИ. Инспекция соблюдения правил Надлежащей клинической практики Росздравнадзором. Качественная клиническая практика. 2018;(1):66–76. https://doi.org/10.24411/2588-0519-2018-10039; Трапкова АА. Проведение фармацевтических инспекций на соответствие требованиям GCP ЕАЭС в Российской Федерации является осознанной необходимостью. Безопасность и риск фармакотерапии. 2023;11(2):127–30. https://doi.org/10.30895/2312-7821-2023-11-2-127-130; Stevens W. Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Qual Assur. 2003;10(2):83–9. https://doi.org/10.1080/10529410390262727; Klausner RD, Fauci AS, Corey L, Nabel GJ, Gayle H, Berkley S, et al. Medicine. The need for a global HIV vaccine enterprise. Science. 2003;300(5628):2036–9. https://doi.org/10.1126/science.1086916; Ezzelle J, Rodriguez-Chavez IR, Darden JM, Stirewalt M, Kunwar N, Hitchcock R, et al. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. J Pharm Biomed Anal. 2008;46(1):18–29. https://doi.org/10.1016/j.jpba.2007.10.010; Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. Evaluation and recommendations on Good Clinical Laboratory Practice guidelines for phase I–III clinical trials. PLoS Medicine. 2009;6(5):e1000067. https://doi.org/10.1371/journal.pmed.1000067; Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. P15-05. Evaluation and recommendations on good clinical laboratory practice (GCLP) guidelines for phase I–III HIV vaccine clinical trials. Retrovirology. 2009;6(3):P206. https://doi.org/10.1186/1742-4690-6-S3-P206; Banoo S, Bell D, Bossuyt P, Herring A, Mabey D, Poole F. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol. 2006;4(9):S21–S31. https://doi.org/10.1038/nrmicro1523; Roy CK. Good Clinical Laboratory Practice (GCLP): quality demanding from clinical laboratories. Bangladesh J Med Microbiol. 2010;4(1):1–5. https://doi.org/10.3329/bjmm.v4i1.8460; Joshi RK, Sarangi SC, Mohapatra S, Mallick S, Datta SK. A comparative review of ICMR, WHO, and EMA guidelines for good clinical laboratory practices. J Lab Physicians. 2023;15(2):179–86. https://doi.org/10.1055/s-0042-1757237; Viana RV, Wallis CL. Good Clinical Laboratory Practice (GCLP) for molecular based tests used in diagnostic laboratories. In: Akyar I. Wide spectra of Quality Control. InTech; 2011. https://doi.org/10.5772/23963; Gumba H, Musyoki J, Mosobo M, Lowe B. Implementation of Good Clinical Laboratory Practice in an immunology basic research laboratory. Am J Clin Pathol. 2019;151(3):270–4. https://doi.org/10.1093/ajcp/aqy138; Patel S, Garima G, Bhatia S, Latha TK, Thakur N, Pujani M, Sharma SB. Effect of Good Clinical Laboratory Practices quality training on knowledge, attitude and practice among laboratory professionals — quasi experimental study. J Clin Diagn Res. 2023;17(9):BC05–BC09. https://doi.org/10.7860/JCDR/2023/62492.18453; Todd CA, Sanchez AM, Garcia A, Denny TN, Sarzotti-Kelsoe M. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J Immunol Methods. 2014;409:91–8. https://doi.org/10.1016/j.jim.2013.09.012; Tzankov A, Tornillo L. Hands-on experience: accreditation of pathology laboratories according to ISO 15189. Patho­ biology. 2017;84(3):121–9. https://doi.org/10.1159/000449254; Zneimer SM. Guidelines for Good Clinical Laboratory Practice. In: Zneimer SM. Cytogenetic laboratory management: chromosomal, FISH and microarray­based best practices and procedures. John Wiley & Sons, Inc.; 2016. P. 1–70. https://doi.org/10.1002/9781119069782.ch1; Gough J, Hamrell M. Standard Operating Procedures (SOPs): Why companies must have them, and why they need them. Ther Innov Regul Sci. 2009;43:69–74. https://doi.org/10.1177/009286150904300112; Amare G. Reviewing the values of a standard operating procedure. Ethiop J Health Sci. 2012;22(3):205–8. PMID: 23209355; Schmidt RH, Pierce PD. The use of Standard Operating Procedures (SOPs). In: Handbook of hygiene control in the food industry. Elsevier Ltd.; 2016. P. 221–3. https://doi.org/10.1016/B978-0-08-100155-4.00016-9; Hollmann S, Frohme M, Endrullat C, Kremer A, D’Elia D, Regierer B, Nechyporenko A. Ten simple rules on how to write a standard operating procedure. PLoS Comput Biol. 2020;16(9):e1008095. https://doi.org/10.1371/journal.pcbi.1008095; Killcross M. Develop Standard Operating Procedures (SOPs). In: Chemical and process plant commissioning hand-book. Elsevier Ltd.; 2021. P. 155–64. https://doi.org/10.1016/B978-0-12-824049-6.00007-X; https://www.vedomostincesmp.ru/jour/article/view/645

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https://doi.org/10.30895/1991-2919-2024-645