Effect Of Different Species Of Anesthesia On Electrocardiogram Parameters In Rats

Lycheva, N A; Макарова, М.Н.; Makarov, V. A.; Rуbakova, A.

doi:10.29296/2618723x-2018-02-02

Cited by 2 publications

(2 citation statements)

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“…Например, в тексте обзора данных научной литературы по ДКИ не указываются ссылки на источники литературы. Согласно Приложению № 13 к Правилам регистрации и экспертизы лекарственных средств для медицинского применения 6 , если заявитель использует данные из научных публикаций либо такие данные применяются в контексте экспертного отчета, необходимо указывать ссылки, позволяющие четко идентифицировать каждую публикацию. Список литературы, с одной стороны, должен включать все использованные в обзоре источники литературы, а с другой -в него не следует включать публикации, которые не были процитированы.…”

Section: недочеты при подготовке обзора научных работ о доклинических...unclassified

“…Необходима критическая оценка полученной информации. Так, при изучении влияния препарата на сердечно-сосудистую систему существенное влияние на характер изменений на электрокардиограмме может быть обусловлено использованием анестезии при проведении исследований [6].…”

Section: должен включать все использованные в обзоре литературные ист...unclassified

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Preparation of a Nonclinical Overview Based on Scientific Literature

Енгалычева¹,

Syubaev²

2021

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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Current requirements for the registration dossier include submission of a preclinical (nonclinical) overview, including scientific literature data on preclinical studies and actual preclinical data on the medicinal product. For some groups of medicines, scientific literature data may be used instead of actual preclinical data, which may be redundant. One of the important functions of the scientific literature review is the analysis of updated preclinical information on the medicinal product, which reflects the product’s characteristics, supports conclusions on its efficacy or safety, and may affect the results of the benefit/risk assessment. The aim of the study was to determine the optimal format for presenting scientific literature data in a nonclinical overview that would reflect the methodological aspects of preclinical pharmacology and toxicology studies of medicines. The authors analysed the regulations of the Russian Federation and the Eurasian Economic Union containing requirements for the scientific literature review submitted instead of actual preclinical data as part of the registration dossier for a medicinal product. The authors also considered potential difficulties in preparing a nonclinical overview based on scientific literature. In order to systematise scientific literature data, it is recommended to provide pharmacodynamic, pharmacokinetic, and toxicological data using a format consistent with the common technical document. The proposed recommendations help to harmonise the process of preparation and design of a nonclinical overview which should contain data and facts enabling a reasoned assessment of the benefit/risk ratio. The standardised format of literature data presentation will help the developer prepare an adequate nonclinical overview and will speed up assessment of clinical trial or marketing authorisation applications.

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Section: недочеты при подготовке обзора научных работ о доклинических...unclassified

Section: должен включать все использованные в обзоре литературные ист...unclassified

Preparation of a Nonclinical Overview Based on Scientific Literature

Енгалычева¹,

Syubaev²

2021

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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Studies of the effect of indole and its derivative 1-benzylindole on the functional state of the heart and blood values of laboratory rats

Gorokhova,

Mikhailova,

Zhukova

et al. 2024

Acta biomedica scientifica

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Background. Indole and its derivatives are widely used in all areas of pharmaceutical production. The toxicometry of indole compounds has been sufficiently studied. At the same time, there is still no information on the toxic effect on individual organs and systems during long-term intake of most compounds.The aim. To carry out an experimental study of the toxic effect of indole and its derivative 1-benzylindole on the functional state of the heart and blood values.Materials and methods. The work was carried out on 46 white rats, divided into groups: control group (n = 22); animals receiving indole once a day for 1 month (n = 12); animals receiving 1-benzylindole once a day for 1 month (n = 12). The substances were administered intragastrically 5 days a week. The condition of the animals was assessed by integral parameters, peripheral blood parameters and biochemical serum tests, and morphological data.Results. Administration of indole and 1-benzylindole caused an increase in the electrical activity of the atria, a decrease in the duration of the QRS complex, and a statistically significant decrease in blood pressure and body temperature compared to the control group. The intake of indole and 1-benzylindole decreased the number of red blood cells and hemoglobin, increased the activity of aspartate aminotransferase and alanine aminotransferase, and increased the concentrations of urea, total cholesterol and triglycerides in the blood. Against the background of long-term exposure to indole and 1-benzylindole, dystrophic disorders, hypertrophic and atrophic changes in individual fibers with a pronounced congestion of the microcirculatory vessels were revealed in the heart of rats.Conclusion. Indole and 1-benzylindole in case of long-term intake lead to functional disorders of the cardiovascular system, which cause the development of arterial hypertension, coronary heart disease, and atherosclerotic vascular lesions. Preventive measures in industries with possible contact with indole and its derivatives should include regular medical examinations of workers with mandatory monitoring of electrocardiography and advanced indicators of general and biochemical blood tests.

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Effect Of Different Species Of Anesthesia On Electrocardiogram Parameters In Rats

Cited by 2 publications

References 0 publications

Preparation of a Nonclinical Overview Based on Scientific Literature

Preparation of a Nonclinical Overview Based on Scientific Literature

Studies of the effect of indole and its derivative 1-benzylindole on the functional state of the heart and blood values of laboratory rats

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