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Information × Registration Number 0211U006182, 0108U000118 , R & D reports Title Creation of the algorythm of functioning of the preclinical investigations institution according to Good Laboratory Practice Standards popup.stage_title Head Tanina S.S., Registration Date 28-02-2011 Organization SI "Institute of Pharmacology and Toxicology AMS of Ukraine" popup.description2 The purpose of the research work was logical design of Good Laboratory Practice requirements implementation into work of laboratories for pre-clinical study of medicines in accordance with the principles of GLP. As methodological approach has been choused creation of the database of regulatory documents on Good Laboratory Practice (EU Directives, Guidelines and recommendations of the OECD, FDA legal documents (USA), publications in foreign journals and monographs of experts), then its classification and generalization of the experience of SI "IPT NAMS Ukraine" employees. Basing on the regulatory documents analyzing and on experience of Institutional scientists in implementation of GLP we summarized data about necessary key elements for functioning of GLP organization for pre-clinical study of medicines. Were identified main deeds for stepwise implementation of GLP into preclinical study process and documentation, necessary for this work, such as for work with customer/sponsor of study, with suppliers (reagents, apparatus, equipment, test-systems, feed, ets.); on the step of study-team building - staff recruitment, seminars preparation, SOP preparation, carrying out of SOP-training) identifying of study premises, necessary equipment, and theirs preparation for handling of test-item, carrying on animals, on the step of plan preparation - choice of study design and preparation of study schedule. Were expounded characteristic of QA group study process monitoring in the framework of quality assurance programme (given some typical examples of documentation, which attracted the way of QA reporting). Was determined main procedure of study report preparation with sweeping generalization of all study data. Logical design of passing of GLP compliance standard inspection for research organization/ laboratory for preclinical drug study was formulated. As a conclusion we could say, that we prepared logical design for step by step implementation of GLP principles into research facility, study process and logical design of GLP compliance inspection process passing. Product Description popup.authors Іванова Ірина Володимирівна Бондаренко Лариса Борисівна Вороніна Алла Костянтиновна Данова Ірина Владиславівна Добреля Наталія Володимирівна Карацуба Тетяна Анатоліївна Коваленко Валентина Миколаївна Полєшко Федор Федорович Сергієнко Ольга Володимирівна Соловйов Анатолій Іванович Тишкін Сергій Михайлович Хромов Олександр Станіславович Шаяхметова Ганна Михайлівна Ядловський Олег Євгенович popup.nrat_date 2020-04-02 Close