Synthesis, molecular docking, ADMET study and in vitro pharmacological research of 7-(2-chlorophenyl)-4-(4-methylthiazol-5-yl)-4,6,7,8-tetrahydroquinoline-2,5(1H,3H)-dione as a promising non-opioid analgesic drug

The discovery of novel drugs that can block the transmission of pain signals for treating the pain of various etiologies is an urgent topic in pharmaceutics. The aim of this paper is to synthesize and to investigate in vitro and in silico characteristics of a promising novel compound: 7-(2-chlorophenyl)-4-(4-methylthiazol-5-yl)-4,6,7,8-tetrahydroquinoline-2,5(1H,3H)-dione (HSV-DKH-0450

Review of the Certification Procedure for Qualified Persons of Manufacturers of Medicines for Human Use in Russia

Scientific relevance. In December 2020, the Russian Federation adopted the Eurasian Economic Union (EAEU) requirements. This has significantly changed the certification procedure for qualified persons (QPs) of manufacturers of medicinal products for human use in the Russian Federation. To accommodate these changes, the Russian regulatory framework needs further improvement.Aim. This study aimed to review the changes made to the mechanism of state regulation of medicines and to evaluate the impact on the pharmaceutical industry two years after the adoption of the current QP certification procedure.Discussion. This review compares two QP certification procedures established by Order No. 7n of the Ministry of Health of the Russian Federation dated 12 January 2021. The first is an abbreviated one for QPs certified under the previous procedure, and the second is an initial one for QPs being certified for the first time, having an expired certificate, or wishing to extend their professional qualification profiles. The article illustrates common mistakes made by certification applicants when preparing their documents. Furthermore, the authors describe the most prevalent knowledge gaps identified by testing. The abbreviated certification procedure ensured a sufficiently smooth transition to the EAEU requirements. For example, by 1 February 2023, 506 QPs were recertified for the next five-year period according to this procedure. This accounts for slightly more than half of all QPs certified in the Russian Federation according to the previous requirements. The total number of QPs certified according to the EAEU requirements in Russia in 2021–2022 is approximately 1.5 times higher than the number of QPs certified during the same period in 2014–2015.Conclusions. The updated procedure for QP certification has noticeably changed the occupational group of QPs formed in the Russian Federation in the last decade. The implementation of the new QP certification procedure has revealed several procedural issues that require additional explanation and clarification by the Ministry of Health of the Russian Federation

Аналитический обзор процедуры аттестации уполномоченных лиц производителей лекарственных средств для медицинского применения в России

Scientific relevance. In December 2020, the Russian Federation adopted the Eurasian Economic Union (EAEU) requirements. This has significantly changed the certification procedure for qualified persons (QPs) of manufacturers of medicinal products for human use in the Russian Federation. To accommodate these changes, the Russian regulatory framework needs further improvement.Aim. This study aimed to review the changes made to the mechanism of state regulation of medicines and to evaluate the impact on the pharmaceutical industry two years after the adoption of the current QP certification procedure.Discussion. This review compares two QP certification procedures established by Order No. 7n of the Ministry of Health of the Russian Federation dated 12 January 2021. The first is an abbreviated one for QPs certified under the previous procedure, and the second is an initial one for QPs being certified for the first time, having an expired certificate, or wishing to extend their professional qualification profiles. The article illustrates common mistakes made by certification applicants when preparing their documents. Furthermore, the authors describe the most prevalent knowledge gaps identified by testing. The abbreviated certification procedure ensured a sufficiently smooth transition to the EAEU requirements. For example, by 1 February 2023, 506 QPs were recertified for the next five-year period according to this procedure. This accounts for slightly more than half of all QPs certified in the Russian Federation according to the previous requirements. The total number of QPs certified according to the EAEU requirements in Russia in 2021–2022 is approximately 1.5 times higher than the number of QPs certified during the same period in 2014–2015.Conclusions. The updated procedure for QP certification has noticeably changed the occupational group of QPs formed in the Russian Federation in the last decade. The implementation of the new QP certification procedure has revealed several procedural issues that require additional explanation and clarification by the Ministry of Health of the Russian Federation.Актуальность. Порядок аттестации уполномоченных лиц производителей лекарственных средств для медицинского применения (УЛ) с декабря 2020 г. претерпел существенные изменения в связи с переходом на требования Евразийского экономического союза (ЕАЭС). Актуальной является необходимость дальнейшего совершенствования соответствующей нормативной базы в российском законодательстве.Цель. Анализ изменений в механизме государственного регулирования сферы обращения лекарственных средств, произошедших за два года применения нового порядка аттестации уполномоченных лиц, и оценка влияния этих изменений на фармацевтическую отрасль.Обсуждение. Представлены результаты сравнительного анализа двух административных процедур аттестации УЛ, установленных приказом Минздрава России от 12.01.2021 № 7н: ускоренной (для УЛ, аттестованных ранее) и первичной (для УЛ, аттестуемых впервые; для УЛ, срок действия аттестации которых истек; в случае необходимости расширения производственных специализаций УЛ). Приведены типичные ошибки заявителей при оформлении документов, описаны наиболее распространенные пробелы знаний заявителей, выявляемые при тестовом контроле. Отмечено, что использование ускоренной процедуры аттестации позволило достаточно плавно осуществить переход на требования к УЛ в ЕАЭС. Так, по состоянию на 01.02.2023 по данной процедуре на новый пятилетний период было заново аттестовано 506 человек, чуть более половины всех ранее аттестованных УЛ в Российской Федерации. Общее количество аттестованных в качестве УЛ за период 2021–2022 гг. выросло в 1,5 раза в сравнении с таким же периодом в 2014–2015 гг.Выводы. Отмечено, что введение обновленного порядка аттестации в Российской Федерации привело к заметным изменениям сформированной в последнее десятилетие профессиональной группы УЛ. При анализе нормативной базы выявлен ряд процедурных вопросов, которые требуют дополнительных уточнений и разъяснений Минздрава России при применении действующего порядка аттестации УЛ

Latent Trait Theory Approach to Measuring Person-Organization Fit: Conceptual Rationale and Empirical Evaluation

The purpose of this article is to offer a new approach to measuring person-organization (P-O) fit, referred to here as “Latent fit.” Respondents were administered unidimensional forced choice items and were asked to choose the statement in each pair that better reflected the correspondence between their values and those of the organization; scaling was done using an item response theory (IRT) model for stimulus endorsement. An empirical study comparing this new approach to two traditional P-O fit measurement approaches was also conducted. The results indicated that the Latent fit approach had merit, with the fit scores exhibiting theoretically expected patterns of relations with other variables and incremental validity in predicting intentions to leave